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Sample records for cardiovascular evaluation trial

  1. Secondary Prevention of Cardiovascular Disease in Patients With Type 2 Diabetes Mellitus: International Insights From the TECOS Trial (Trial Evaluating Cardiovascular Outcomes With Sitagliptin).

    Science.gov (United States)

    Pagidipati, Neha J; Navar, Ann Marie; Pieper, Karen S; Green, Jennifer B; Bethel, M Angelyn; Armstrong, Paul W; Josse, Robert G; McGuire, Darren K; Lokhnygina, Yuliya; Cornel, Jan H; Halvorsen, Sigrun; Strandberg, Timo E; Delibasi, Tuncay; Holman, Rury R; Peterson, Eric D

    2017-09-26

    Intensive risk factor modification significantly improves outcomes for patients with diabetes mellitus and cardiovascular disease. However, the degree to which secondary prevention treatment goals are achieved in international clinical practice is unknown. Attainment of 5 secondary prevention parameters-aspirin use, lipid control (low-density lipoprotein cholesterol diabetes mellitus and known cardiovascular disease at entry into TECOS (Trial Evaluating Cardiovascular Outcomes With Sitagliptin). Logistic regression was used to evaluate the association between individual and regional factors and secondary prevention achievement at baseline. Cox proportional hazards regression analysis was used to determine the association between baseline secondary prevention achievement and cardiovascular death, myocardial infarction, or stroke. Overall, 29.9% of patients with diabetes mellitus and cardiovascular disease achieved all 5 secondary prevention parameters at baseline, although 71.8% achieved at least 4 parameters. North America had the highest proportion (41.2%), whereas Western Europe, Eastern Europe, and Latin America had proportions of ≈25%. Individually, blood pressure control (57.9%) had the lowest overall attainment, whereas nonsmoking status had the highest (89%). Over a median 3.0 years of follow-up, a higher baseline secondary prevention score was associated with improved outcomes in a step-wise graded relationship (adjusted hazard ratio, 0.60; 95% confidence interval, 0.47-0.77 for those patients achieving all 5 measures versus those achieving ≤2). In an international trial population, significant opportunities exist to improve the quality of cardiovascular secondary prevention care among patients with diabetes mellitus and cardiovascular disease, which in turn could lead to reduced risk of downstream cardiovascular events. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00790205. © 2017 American Heart Association, Inc.

  2. Hypertension Control in Adults With Diabetes Mellitus and Recurrent Cardiovascular Events: Global Results From the Trial Evaluating Cardiovascular Outcomes With Sitagliptin.

    Science.gov (United States)

    Navar, Ann Marie; Gallup, Dianne S; Lokhnygina, Yuliya; Green, Jennifer B; McGuire, Darren K; Armstrong, Paul W; Buse, John B; Engel, Samuel S; Lachin, John M; Standl, Eberhard; Van de Werf, Frans; Holman, Rury R; Peterson, Eric D

    2017-11-01

    Systolic blood pressure (SBP) treatment targets for adults with diabetes mellitus remain unclear. SBP levels among 12 275 adults with diabetes mellitus, prior cardiovascular disease, and treated hypertension were evaluated in the TECOS (Trial Evaluating Cardiovascular Outcomes With Sitagliptin) randomized trial of sitagliptin versus placebo. The association between baseline SBP and recurrent cardiovascular disease was evaluated using multivariable Cox proportional hazards modeling with restricted cubic splines, adjusting for clinical characteristics. Kaplan-Meier curves by baseline SBP were created to assess time to cardiovascular disease and 2 potential hypotension-related adverse events: worsening kidney function and fractures. The association between time-updated SBP and outcomes was examined using multivariable Cox proportional hazards models. Overall, 42.2% of adults with diabetes mellitus, cardiovascular disease, and hypertension had an SBP ≥140 mm Hg. The association between SBP and cardiovascular disease risk was U shaped, with a nadir ≈130 mm Hg. When the analysis was restricted to those with baseline SBP of 110 to 150 mm Hg, the adjusted association between SBP and cardiovascular disease risk was flat (hazard ratio per 10-mm Hg increase, 0.96; 95% confidence interval, 0.91-1.02). There was no association between SBP and risk of fracture. Above 150 mm Hg, higher SBP was associated with increasing risk of worsening kidney function (hazard ratio per 10-mm Hg increase, 1.10; 95% confidence interval, 1.02-1.18). Many patients with diabetes mellitus have uncontrolled hypertension. The U-shaped association between SBP and cardiovascular disease events was largely driven by those with very high or low SBP, with no difference in cardiovascular disease risk between 110 and 150 mm Hg. Lower SBP was not associated with higher risks of fractures or worsening kidney function. © 2017 American Heart Association, Inc.

  3. Randomized controlled trials and real-world observational studies in evaluating cardiovascular safety of inhaled bronchodilator therapy in COPD

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    Kardos P

    2016-11-01

    Full Text Available Peter Kardos,1 Sally Worsley,2 Dave Singh,3 Miguel Román-Rodríguez,4 David E Newby,5 Hana Müllerová2 1Group Practice and Respiratory, Allergy and Sleep Unit, Red Cross Maingau Hospital, Frankfurt, Germany; 2GSK, Stockley Park, Middlesex, 3University of Manchester, Medicines Evaluation Unit, University Hospital of South Manchester NHS Foundation Trust, Manchester, UK; 4Primary Care Respiratory Research Unit, Instituto de Investigación Sanitaria de Palma IdisPa, Palma de Mallorca, Spain; 5BHF Centre for Cardiovascular Science, University of Edinburgh, The Queen’s Medical Research Institute, Edinburgh, UK Abstract: Long-acting muscarinic antagonist (LAMA or long-acting β2-agonist (LABA bronchodilators and their combination are recommended for the maintenance treatment of chronic obstructive pulmonary disease (COPD. Although the efficacy of LAMAs and LABAs has been well established through randomized controlled trials (RCTs, questions remain regarding their cardiovascular (CV safety. Furthermore, while the safety of LAMA and LABA monotherapy has been extensively studied, data are lacking for LAMA/LABA combination therapy, and the majority of the studies that have reported on the CV safety of LAMA/LABA combination therapy were not specifically designed to assess this. Evaluation of CV safety for COPD treatments is important because many patients with COPD have underlying CV comorbidities. However, severe CV and other comorbidities are often exclusion criteria for RCTs, contributing to a lack in external validity and generalizability. Real-world observational studies are another important tool to evaluate the effectiveness and safety of COPD therapies in a broader population of patients and can improve upon the external validity limitations of RCTs. We examine what is already known regarding the CV and cerebrovascular safety of LAMA/LABA combination therapy from RCTs and real-world observational studies, and explore the advantages and

  4. Trials of testosterone replacement reporting cardiovascular adverse events

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    Thiago Gagliano-Jucá

    2018-01-01

    Full Text Available The numbers of testosterone prescriptions written have increased several-fold worldwide, but the incidence of pathological hypogonadism due to hypothalamic, pituitary, and testicular disease has remained unchanged. Most of these prescriptions are being dispensed to middle-aged and older men who have experienced age-related decline in serum testosterone levels; a subset of the population in which benefits of testosterone replacement is at best, modest. Recently, some randomized controlled trials have reported increased cardiovascular events in men (mainly older men and those with prevalent cardiovascular disease with testosterone use, and a few recent meta-analyses have confirmed these findings. In this review, we discuss trials of testosterone therapy that have reported higher cardiovascular events, relevant trials that have not reported increased cardiovascular events and large trials that have focused on cardiovascular risk (mainly atherosclerosis progression as their main outcome. We also review findings from meta-analyses that have evaluated cardiovascular events in various testosterone trials. Finally, we discuss some potential mechanisms by which testosterone use might result in an increased cardiovascular risk. As none of the trials conducted to date were adequately powered to evaluate cardiovascular events, no firm conclusions can be drawn regarding the cardiovascular safety of testosterone therapy at this time. In the interim, we hope that this review will help practitioners make informed decisions regarding the care of their patients.

  5. LEADER 7 : Cardiovascular risk profiles of US and European participants in the LEADER diabetes trial differ

    NARCIS (Netherlands)

    Rutten, Guy E H M; Tack, Cees J.; Pieber, Thomas R.; Comlekci, Abdurrahman; Ørsted, David Dynnes; Baeres, Florian M M; Marso, Steven P.; Buse, John B.

    2016-01-01

    Aims: To determine whether US and European participants in the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial differ regarding risk factors for cardiovascular mortality and morbidity. Methods: Baseline data, stratified for prior cardiovascular

  6. Longitudinal Medical Resources and Costs Among Type 2 Diabetes Patients Participating in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS).

    Science.gov (United States)

    Reed, Shelby D; Li, Yanhong; Leal, Jose; Radican, Larry; Adler, Amanda I; Alfredsson, Joakim; Buse, John B; Green, Jennifer B; Kaufman, Keith D; Riefflin, Axel; Van de Werf, Frans; Peterson, Eric D; Gray, Alastair M; Holman, Rury R

    2018-03-23

    TECOS, a cardiovascular safety trial of 14,671 patients with type 2 diabetes and cardiovascular disease, demonstrated sitagliptin was non-inferior to placebo for the primary composite cardiovascular outcome when added to best usual care. This study tested hypotheses that medical resource use and costs differed between these two treatment strategies. Medical resource use information was collected on case report forms throughout the trial and valued using US costs: Medicare payments for hospitalizations, medical procedures, and outpatient visits, and wholesale acquisition costs (WAC) for diabetes-related medications. Hierarchical generalized linear models were used to compare resource use and US costs, accounting for variable intercountry practice patterns. Sensitivity analyses included resource valuation using English costs for a UK perspective. There were no significant differences in hospitalizations, inpatient days, medical procedures, or outpatient visits during follow-up (mean and median 3.0 years in both groups). Hospitalization rates appeared to diverge after 2 years, with lower rates among sitagliptin vs. placebo-treated patients with at least 2.5 years (relative rate, 0.90 [95%CI: 0.83-0.97], P=0.01). Mean medical costs, exclusive of study medication, were $11,937 in the sitagliptin and $12,409 in placebo arm (P=0.06). Mean sitagliptin costs based on undiscounted WAC were $9,978 per patient. Differential UK total costs including study drug costs were smaller (£911), primarily due to lower mean costs for sitagliptin (£1,072). Lower hospitalization rates across time with sitagliptin slightly offset sitagliptin treatment costs over 3 years in type 2 diabetes patients at high risk for cardiovascular events. ClinicalTrials.gov identifier: NCT00790205. This article is protected by copyright. All rights reserved.

  7. Excess pressure integral predicts cardiovascular events independent of other risk factors in the conduit artery functional evaluation substudy of Anglo-Scandinavian Cardiac Outcomes Trial.

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    Davies, Justin E; Lacy, Peter; Tillin, Therese; Collier, David; Cruickshank, J Kennedy; Francis, Darrel P; Malaweera, Anura; Mayet, Jamil; Stanton, Alice; Williams, Bryan; Parker, Kim H; McG Thom, Simon A; Hughes, Alun D

    2014-07-01

    Excess pressure integral (XSPI), a new index of surplus work performed by the left ventricle, can be calculated from blood pressure waveforms and may indicate circulatory dysfunction. We investigated whether XSPI predicted future cardiovascular events and target organ damage in treated hypertensive individuals. Radial blood pressure waveforms were acquired by tonometry in 2069 individuals (aged, 63±8 years) in the Conduit Artery Functional Evaluation (CAFE) substudy of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT). Measurements of left ventricular mass index (n=862) and common carotid artery intima media thickness (n=923) were also performed. XSPI and the integral of reservoir pressure were lower in people treated with amlodipine±perindopril than in those treated with atenolol±bendroflumethiazide, although brachial systolic blood pressure was similar. A total of 134 cardiovascular events accrued during a median 3.4 years of follow-up; XSPI was a significant predictor of cardiovascular events after adjustment for age and sex, and this relationship was unaffected by adjustment for conventional cardiovascular risk factors or Framingham risk score. XSPI, central systolic blood pressure, central augmentation pressure, central pulse pressure, and integral of reservoir pressure were correlated with left ventricular mass index, but only XSPI, augmentation pressure, and central pulse pressure were associated positively with carotid artery intima media thickness. Associations between left ventricular mass index, XSPI, and integral of reservoir pressure and carotid artery intima media thickness and XSPI were unaffected by multivariable adjustment for other covariates. XSPI is a novel indicator of cardiovascular dysfunction and independently predicts cardiovascular events and targets organ damage in a prospective clinical trial. © 2014 American Heart Association, Inc.

  8. The kidney and cardiovascular outcome trials.

    Science.gov (United States)

    Bloomgarden, Zachary

    2018-02-01

    Chronic kidney disease (CKD) affects a substantial minority of people with type 2 diabetes (T2D). Analysis of US National Health and Nutrition Examination Survey (NHANES) datasets from 2007 through 2012 showed Stage 3 or worse disease (estimated glomerular filtration rate [eGFR] effect of blood pressure lowering was also demonstrated, and the UK Prospective Diabetes Study (UKPDS). However, over the past decade a host of cardiovascular outcome trials (CVOTs) have been performed with newer T2D therapeutic agents, and many of these have included intriguing information pertaining to renal disease and renal outcomes not necessarily related to changes in glycemia. It is of interest to review some of these findings. Glucagon-like peptide-1 (GLP-1) has been reported to increase glomerular filtration rate (GFR), renal blood flow, and the fractional excretion both of sodium and potassium, with renal GLP-1 receptors present in afferent arteriolar vascular smooth muscle cells, glomerular endothelial cells and macrophages, juxtaglomerular cells, and the proximal tubule, perhaps mediating the greater natriuresis seen after oral than intravenous sodium. In the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial, the significant 13% reduction in the primary composite outcome of cardiovascular death, myocardial infarction, and stroke was found on subgroup analysis to particularly occur among participants with Stage 3 CKD, having eGFR 30-59 mL/min per 1.73 m 2 . No significant effect on eGFR was found with liraglutide, although both those receiving and not receiving the drug showed a decline in eGFR from approximately 75 to 65 mL/min per 1.73 m 2 over the 48-month period of observation. Liraglutide administration was associated with a significant reduction in albuminuria, with nearly a 25% lower likelihood of development of macroalbuminuria, and with the albumin:  creatinine ratio (ACR) approximately 20% lower among

  9. Cholesterol Efflux Capacity, High-Density Lipoprotein Particle Number, and Incident Cardiovascular Events: An Analysis From the JUPITER Trial (Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin).

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    Khera, Amit V; Demler, Olga V; Adelman, Steven J; Collins, Heidi L; Glynn, Robert J; Ridker, Paul M; Rader, Daniel J; Mora, Samia

    2017-06-20

    Recent failures of drugs that raised high-density lipoprotein (HDL) cholesterol levels to reduce cardiovascular events in clinical trials have led to increased interest in alternative indices of HDL quality, such as cholesterol efflux capacity, and HDL quantity, such as HDL particle number. However, no studies have directly compared these metrics in a contemporary population that includes potent statin therapy and low low-density lipoprotein cholesterol. HDL cholesterol levels, apolipoprotein A-I, cholesterol efflux capacity, and HDL particle number were assessed at baseline and 12 months in a nested case-control study of the JUPITER trial (Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin), a randomized primary prevention trial that compared rosuvastatin treatment to placebo in individuals with normal low-density lipoprotein cholesterol but increased C-reactive protein levels. In total, 314 cases of incident cardiovascular disease (CVD) (myocardial infarction, unstable angina, arterial revascularization, stroke, or cardiovascular death) were compared to age- and gender-matched controls. Conditional logistic regression models adjusting for risk factors evaluated associations between HDL-related biomarkers and incident CVD. Cholesterol efflux capacity was moderately correlated with HDL cholesterol, apolipoprotein A-I, and HDL particle number (Spearman r = 0.39, 0.48, and 0.39 respectively; P JUPITER, cholesterol efflux capacity was associated with incident CVD in individuals on potent statin therapy but not at baseline. For both baseline and on-statin analyses, HDL particle number was the strongest of 4 HDL-related biomarkers as an inverse predictor of incident events and biomarker of residual risk. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00239681. © 2017 American Heart Association, Inc.

  10. Streamlining cardiovascular clinical trials to improve efficiency and generalisability.

    Science.gov (United States)

    Zannad, Faiez; Pfeffer, Marc A; Bhatt, Deepak L; Bonds, Denise E; Borer, Jeffrey S; Calvo-Rojas, Gonzalo; Fiore, Louis; Lund, Lars H; Madigan, David; Maggioni, Aldo Pietro; Meyers, Catherine M; Rosenberg, Yves; Simon, Tabassome; Stough, Wendy Gattis; Zalewski, Andrew; Zariffa, Nevine; Temple, Robert

    2017-08-01

    Controlled trials provide the most valid determination of the efficacy and safety of an intervention, but large cardiovascular clinical trials have become extremely costly and complex, making it difficult to study many important clinical questions. A critical question, and the main objective of this review, is how trials might be simplified while maintaining randomisation to preserve scientific integrity and unbiased efficacy assessments. Experience with alternative approaches is accumulating, specifically with registry-based randomised controlled trials that make use of data already collected. This approach addresses bias concerns while still capitalising on the benefits and efficiencies of a registry. Several completed or ongoing trials illustrate the feasibility of using registry-based controlled trials to answer important questions relevant to daily clinical practice. Randomised trials within healthcare organisation databases may also represent streamlined solutions for some types of investigations, although data quality (endpoint assessment) is likely to be a greater concern in those settings. These approaches are not without challenges, and issues pertaining to informed consent, blinding, data quality and regulatory standards remain to be fully explored. Collaboration among stakeholders is necessary to achieve standards for data management and analysis, to validate large data sources for use in randomised trials, and to re-evaluate ethical standards to encourage research while also ensuring that patients are protected. The rapidly evolving efforts to streamline cardiovascular clinical trials have the potential to lead to major advances in promoting better care and outcomes for patients with cardiovascular disease. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  11. Evaluation of a toolkit to improve cardiovascular disease screening and treatment for people with type 2 diabetes: protocol for a cluster-randomized pragmatic trial

    Directory of Open Access Journals (Sweden)

    Bhattacharyya Onil

    2010-04-01

    Full Text Available Abstract Background The gap between the level of care recommended by evidence-based clinical practice guidelines and the actual care delivered to patients in practice has been well established. The Canadian Diabetes Association (CDA created an implementation strategy to improve the implementation of its 2008 guidelines. This study will evaluate the impact of the strategy to improve cardiovascular disease (CVD screening, prevention and treatment for people with diabetes. Design A pragmatic cluster-randomized trial will be conducted to evaluate the CDA's CVD Toolkit. All family physicians in Ontario, Canada were randomly allocated to receive the Toolkit, which includes several printed educational materials targeting CVD screening, prevention and treatment, either in spring 2009 (intervention arm or in spring 2010 (control arm. Randomization occurred at the level of the practice. Forty family physicians from each arm will be recruited to participate, and the medical records for 20 of their diabetic patients at high risk for CVD will be retrospectively reviewed. Outcome measures will be assessed for each patient between July 2009 and March 2010. The primary outcome will be that the patient is receiving a statin. Secondary outcomes will include 1 the receipt of an angiotensin converting enzyme inhibitor or angiotensin receptor blocker, 2 various intermediate measures (A1c, blood pressure, LDL-cholesterol, total-/HDL-cholesterol ratio, body mass index and waist circumference, and 3 clinical inertia (the failure to change therapy in response to an abnormal A1c, blood pressure or cholesterol reading. The analysis will be carried out using multilevel hierarchical logistic regression models to account for the clustered nature of the data. The group assignment will be a physician-level variable. In addition, a process evaluation study with six focus groups of family physicians will assess the acceptability of the CDA's Toolkit and will explore factors

  12. Evaluation of the Effectiveness of Tai Chi versus Brisk Walking in Reducing Cardiovascular Risk Factors: Protocol for a Randomized Controlled Trial

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    Aileen W. K. Chan

    2016-07-01

    Full Text Available Physical inactivity is one of the major modifiable lifestyle risk factors for cardiovascular disease (CVD. This protocol aims to evaluate the effectiveness of Tai Chi versus brisk walking in reducing CVD risk factors. This is a randomized controlled trial with three arms, namely, Tai Chi group, walking group, and control group. The Tai Chi group will receive Tai Chi training, which consists of two 60-min sessions each week for three months, and self-practice for 30 min every day. The walking group will perform brisk walking for 30 min every day. The control group will receive their usual care. 246 subjects with CVD risk factors will be recruited from two outpatient clinics. The primary outcome is blood pressure. Secondary outcomes include fasting blood for lipid profile, sugar and glycated haemoglobin (HbA1c; body mass index, waist circumference, body fat percentage; perceived stress level and quality of life. Data collections will be conducted at baseline, 3-month, 6-month and 9-month. Generalized estimating equations model will be used to compare the changes in outcomes across time between groups. It is expected that both the Tai Chi and walking groups could maintain better health and have improved quality of life, and that Tai Chi will be more effective than brisk walking in reducing CVD risk factors.

  13. A phase I open-label trial evaluating the cardiovascular safety of regorafenib in patients with advanced cancer.

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    Jones, Robin L; Bendell, Johanna C; Smith, David C; Diefenbach, Konstanze; Lettieri, John; Boix, Oliver; Lockhart, A Craig; O'Bryant, Cindy; Moore, Kathleen N

    2015-10-01

    To characterize the cardiovascular safety profile of regorafenib in patients with advanced cancer. Patients received regorafenib 160 mg/day for 21 days followed by a 7-day break. The primary endpoint was the change from baseline in QTcF at the regorafenib t(max) (Day 21, Cycle 1 or 2) and changes in left ventricular ejection fraction (LVEF) from baseline on Cycle 2, Day 21. Secondary objectives were pharmacokinetics, safety, anti-tumor activity and effects on electrocardiogram intervals. QT intervals were corrected using the methods of Fridericia (QTcF) and Bazett (QTcB). LVEF was assessed by multigated acquisition scanning. Fifty-three patients were enrolled, and all received at least one dose of regorafenib 160 mg. Twenty-five patients received regorafenib for 21 days without dose reduction. The mean change from baseline in QTcF at t(max) was (-)2 ms (90 % CI -8, 3). No patient experienced a change from baseline in QTcF > 60 ms, and two had QTcF changes between 30 and 60 ms. No patient had a QTcF or QTcB > 480 ms. In 27 patients who received at least 80 mg of regorafenib, the mean change from baseline in LVEF% ± SD was 1.7 ± 7.8. In 14 patients without a dose reduction, the mean change from baseline in LVEF% was (-)0.1 ± 8.6 at Cycle 2, Day 21. Four patients experienced a LVEF decrease between 10 and 20 %. The effects of regorafenib on the QT/QTc interval and LVEF were modest and unlikely to be of clinical significance in the setting of advanced cancer therapy.

  14. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial

    DEFF Research Database (Denmark)

    Home, Philip D; Pocock, Stuart J; Beck-Nielsen, Henning

    2009-01-01

    BACKGROUND: Rosiglitazone is an insulin sensitiser used in combination with metformin, a sulfonylurea, or both, for lowering blood glucose in people with type 2 diabetes. We assessed cardiovascular outcomes after addition of rosiglitazone to either metformin or sulfonylurea compared with the comb......BACKGROUND: Rosiglitazone is an insulin sensitiser used in combination with metformin, a sulfonylurea, or both, for lowering blood glucose in people with type 2 diabetes. We assessed cardiovascular outcomes after addition of rosiglitazone to either metformin or sulfonylurea compared...... with the combination of the two over 5-7 years of follow-up. We also assessed comparative safety. METHODS: In a multicentre, open-label trial, 4447 patients with type 2 diabetes on metformin or sulfonylurea monotherapy with mean haemoglobin A(1c) (HbA(1c)) of 7.9% were randomly assigned to addition of rosiglitazone (n...... failure and of some fractures, mainly in women. Although the data are inconclusive about any possible effect on myocardial infarction, rosiglitazone does not increase the risk of overall cardiovascular morbidity or mortality compared with standard glucose-lowering drugs. FUNDING: GlaxoSmithKline plc, UK....

  15. Evaluating the effects of sevelamer carbonate on cardiovascular structure and function in chronic renal impairment in Birmingham: the CRIB-PHOS randomised controlled trial

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    Steeds Richard P

    2011-02-01

    Full Text Available Abstract Background Serum phosphate is an independent predictor of cardiovascular morbidity and mortality in patients with chronic kidney disease and the general population. There is accumulating evidence that phosphate promotes arterial stiffening through structural vascular alterations such as medial calcification, which are already apparent in the early stages of chronic kidney disease. Aim To determine the effects of phosphate binding with sevelamer carbonate on left ventricular mass and function together with arterial stiffness in patients with stage 3 chronic kidney disease. Methods/Design A single-centre, prospective, randomised, double-blind, placebo-controlled trial of 120 subjects with stage 3 chronic kidney disease recruited from University Hospitals Birmingham NHS Foundation Trust. Baseline investigations include transthoracic echocardiography and cardiac magnetic resonance imaging to assess ventricular mass, volumes and function, applanation tonometry to determine pulse wave velocity and pulse wave analysis as surrogate measures of arterial stiffness and dual energy x-ray absorptiometry scanning to determine bone density. During an open-label run in phase, subjects will receive 1600 mg sevelamer carbonate with meals for four weeks. They will then be randomised to either continue sevelamer carbonate or receive an identical placebo (60 subjects per arm for the remaining 36 weeks. Four-weekly monitoring of serum electrolytes and bone biochemistry will be performed. All baseline investigations will be repeated at the end of the treatment period. The primary endpoint of the study is a reduction in left ventricular mass after 40 weeks of treatment. Secondary endpoints are: i change in aortic compliance; ii change in arterial stiffness; iii change in arterial elastance; iv change in left ventricular systolic and diastolic elastance; v change in left ventricular function; and vi change in bone density. Trial Registration This trial is

  16. The Danish Cardiovascular Screening Trial (DANCAVAS)

    DEFF Research Database (Denmark)

    Diederichsen, Axel Cosmus Pyndt; Rasmussen, Lars Melholt; Søgaard, Rikke

    2015-01-01

    BACKGROUND: The significant increase in the average life expectancy has increased the societal challenge of managing serious age-related diseases, especially cancer and cardiovascular diseases. A routine check by a general practitioner is not sufficient to detect incipient cardiovascular disease...... to cardiovascular seven-faceted screening examinations at one of four locations. The screening will include: (1) low-dose non-contrast CT scan to detect coronary artery calcification and aortic/iliac aneurysms, (2) brachial and ankle blood pressure index to detect peripheral arterial disease and hypertension, (3......) a telemetric assessment of the heart rhythm, and (4) a measurement of the cholesterol and plasma glucose levels. Up-to-date cardiovascular preventive treatment is recommended in case of positive findings. OBJECTIVE: To investigate whether advanced cardiovascular screening will prevent death and cardiovascular...

  17. Trials of cardiovascular risk factor management in type 2 diabetes.

    NARCIS (Netherlands)

    Patel, A.; Joshi, R.; Galan, B.E. de

    2009-01-01

    PURPOSE OF REVIEW: To provide an overview of recent clinical trial findings relevant to cardiovascular risk management in patients with diabetes. RECENT FINDINGS: Recent trial evidence has demonstrated benefits of routine blood pressure (BP) lowering, regardless of initial BP levels, in people with

  18. Current trends in the cardiovascular clinical trial arena (I

    Directory of Open Access Journals (Sweden)

    Pater Cornel

    2004-06-01

    Full Text Available Abstract The existence of effective therapies for most cardiovascular disease states, coupled with increased requirements that potential benefits of new drugs be evaluated on clinical rather than surrogate endpoints, makes it increasingly difficult to substantiate any incremental improvements in efficacy that these new drugs might offer. Compounding the problem is the highly controversial issue of comparing new agents with placebos rather than active pharmaceuticals in drug efficacy trials. Despite the recent consensus that placebos may be used ethically in well-defined, justifiable circumstances, the problem persists, in part because of increased scrutiny by ethics committees but also because of considerable lingering disagreement regarding the propriety and scientific value of placebo-controlled trials (and trials of antihypertensive drugs in particular. The disagreement also substantially affects the most viable alternative to placebo-controlled trials: actively controlled equivalence/noninferiority trials. To a great extent, this situation was prompted by numerous previous trials of this type that were marked by fundamental methodological flaws and consequent false claims, inconsistencies, and potential harm to patients. As the development and use of generic drugs continue to escalate, along with concurrent pressure to control medical costs by substituting less-expensive therapies for established ones, any claim that a new drug, intervention, or therapy is "equivalent" to another should not be accepted without close scrutiny. Adherence to proper methods in conducting studies of equivalence will help investigators to avoid false claims and inconsistencies. These matters will be addressed in the third article of this three-part series.

  19. Usefulness of proteinuria as a prognostic marker of mortality and cardiovascular events among patients undergoing percutaneous coronary intervention (data from the Evaluation of Oral Xemilofiban in Controlling Thrombotic Events [EXCITE] trial).

    Science.gov (United States)

    Mercado, Nestor; Brugts, Jasper J; Ix, Joachim H; Shlipak, Michael G; Dixon, Simon R; Gersh, Bernard J; Lemos, Pedro A; Guarneri, Mimi; Teirstein, Paul S; Wijns, William; Serruys, Patrick W; Boersma, Eric; O'Neill, William W

    2008-11-01

    Proteinuria was associated with cardiovascular events and mortality in community-based cohorts. The association of proteinuria with mortality and cardiovascular events in patients undergoing percutaneous coronary intervention (PCI) was unknown. The association of urinary dipstick proteinuria with mortality and cardiovascular events (composite of death, myocardial infarction, or nonhemorrhagic stroke) in 5,835 subjects of the EXCITE trial was evaluated. Dipstick urinalysis was performed before PCI, and proteinuria was defined as trace or greater. Subjects were followed up for 210 days/7 months after enrollment for the occurrence of events. Multivariate Cox regression analysis evaluated the independent association of proteinuria with each outcome. Mean age was 59 years, 21% were women, 18% had diabetes mellitus, and mean estimated glomerular filtration rate was 90 ml/min/1.73 m(2). Proteinuria was present in 750 patients (13%). During follow-up, 22 subjects (2.9%) with proteinuria and 54 subjects (1.1%) without proteinuria died (adjusted hazard ratio 2.83, 95% confidence interval [CI] 1.65 to 4.84, p use tool as urinary dipstick may be useful to identify and treat patients at high risk of mortality at the time of PCI.

  20. Cost-effectiveness of rosuvastatin 20 mg for the prevention of cardiovascular morbidity and mortality: a Swedish economic evaluation of the JUPITER trial.

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    Ohsfeldt, Robert L; Olsson, Anders G; Jensen, Marie M; Gandhi, Sanjay K; Paulsson, Thomas

    2012-01-01

    This study estimated the long-term health outcomes, healthcare costs, and cost-effectiveness of rosuvastatin 20 mg therapy in primary prevention of major cardiovascular disease (CVD) in a Swedish population. Based on data from the JUPITER trial, long-term CVD outcomes with rosuvastatin vs no active treatment were estimated for patients with an elevated baseline CVD risk (Framingham CVD score >20%, sub-population of JUPITER population) and for a population similar to the total JUPITER population. Using a decision-analytic model, trial CVD event rates were combined with epidemiological and cost data specific for Sweden. First and subsequent CVD events and death were estimated over a lifetime perspective. The observed relative risk reduction was extrapolated beyond the trial duration. Incremental effectiveness was measured as life-years gained (LYG) and quality-adjusted life-years (QALYs) gained. Treating 100,000 patients with rosuvastatin 20 mg was estimated to avoid 14,692 CVD events over the lifetime (8021 non-fatal MIs, 3228 non-fatal strokes, and 4924 CVD deaths) compared to placebo. This translated into an estimated gain of 42,122 QALYs and 36,865 total life years (LYG). Rosuvastatin was both more effective and less costly over a lifetime perspective, and rosuvastatin is subsequently a dominant alternative compared to no treatment in the assessed population. Using the overall JUPITER population, rosuvastatin was dominant for the lifetime horizon. In the sensitivity analysis, rosuvastatin was the dominant treatment strategy over a 20-year time horizon, and cost-effective with an incremental cost-effectiveness ratio (cost per QALY) of SEK 1783 over a 10-year time horizon. Some model inputs were derived from literature or other data sources, but uncertainty was controlled by sensitivity analyses. Results indicate that rosuvastatin 20 mg treatment is a cost-effective option vs no-treatment in patients with Framingham CVD risk >20% in Sweden and might even be

  1. Cardiovascular drug trials: how to examine interaction, and why so

    NARCIS (Netherlands)

    Cleophas, T. J.; Zwinderman, A. H.; van Ouwerkerk, B.; Sobh, M.

    2007-01-01

    Background: In practice the benefit of cardiovascular medicines is less consistent than it is in clinical trials. This is due to multiple uncontrolled factors that co-determine the efficacy of the new treatment. In statistical terms, they interact with the new treatment. Interaction effects are

  2. Atherogenic Lipoprotein Subfractions Determined by Ion Mobility and First Cardiovascular Events After Random Allocation to High-Intensity Statin or Placebo: The Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) Trial.

    Science.gov (United States)

    Mora, Samia; Caulfield, Michael P; Wohlgemuth, Jay; Chen, Zhihong; Superko, H Robert; Rowland, Charles M; Glynn, Robert J; Ridker, Paul M; Krauss, Ronald M

    2015-12-08

    Cardiovascular disease (CVD) can occur in individuals with low low-density lipoprotein (LDL) cholesterol (LDL-C). We investigated whether detailed measures of LDL subfractions and other lipoproteins can be used to assess CVD risk in a population with both low LDL-C and high C-reactive protein who were randomized to high-intensity statin or placebo. In 11 186 Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) participants, we tested whether lipids, apolipoproteins, and ion mobility-measured particle concentrations at baseline and after random allocation to rosuvastatin 20 mg/d or placebo were associated with first CVD events (n=307) or CVD/all-cause death (n=522). In placebo-allocated participants, baseline LDL-C was not associated with CVD (adjusted hazard ratio [HR] per SD, 1.03; 95% confidence interval [CI], 0.88-1.21). In contrast, associations with CVD events were observed for baseline non-high-density lipoprotein (HDL) cholesterol (HR, 1.18; 95% CI, 1.01-1.38), apolipoprotein B (HR, 1.28; 95% CI, 1.11-1.48), and ion mobility-measured non-HDL particles (HR, 1.19; 95% CI, 1.05-1.35) and LDL particles (HR, 1.21; 95% CI, 1.07-1.37). Association with CVD events was also observed for several LDL and very-low-density lipoprotein subfractions but not for ion mobility-measured HDL subfractions. In statin-allocated participants, CVD events were associated with on-treatment LDL-C, non-HDL cholesterol, and apolipoprotein B; these were also associated with CVD/all-cause death, as were several LDL and very-low-density lipoprotein subfractions, albeit with a pattern of association that differed from the baseline risk. In JUPITER, baseline LDL-C was not associated with CVD events, in contrast with significant associations for non-HDL cholesterol and atherogenic particles: apolipoprotein B and ion mobility-measured non-HDL particles, LDL particles, and select subfractions of very-low-density lipoprotein particles and

  3. [Treatment of patients with type 2 diabetes mellitus: cardiovascular safety of incretin-based therapy supported by the ELIXA and TECOS trials].

    Science.gov (United States)

    Avogaro, Angelo

    2016-04-01

    The risk of morbidity and mortality from cardiovascular disease in patients with type 2 diabetes is about 2-fold higher compared to their non-diabetic counterparts. In December 2008, the Food and Drug Administration published guidelines for the evaluation of cardiovascular risk in new antidiabetic therapies. A shift of emphasis occurred from short-term glycated hemoglobin-centered trials to trials testing cardiovascular safety. The SAVOR-TIMI 53 and the EXAMINE trials with the dipeptidyl peptidase 4 (DPP-4) inhibitors saxagliptin and alogliptin were cardiovascular neutral. The publication of the results of the TECOS trial with sitagliptin, another DPP-4 inhibitor, the American Diabetes Association 2015 presentation of the ELIXA trial with lixisenatide, the first cardiovascular safety trial with glucagon-like peptide 1 receptor agonists, have also been completed. They both show cardiovascular neutrality in very high-risk diabetic patients. The results of these trials are interpreted in the context of diabetic treatment.

  4. [Cardiovascular effects of insulin therapy: from pharmacology to clinical trials].

    Science.gov (United States)

    Mannucci, Edoardo

    2016-03-01

    Insulin has direct effects on vascular walls which, depending on experimental models, can be either predominantly antiatherogenic or proatherogenic. In observational studies, insulin therapy is usually associated with an increase in the incidence of major cardiovascular events. However, this result is probably determined by the effect of confounders. In clinical trials performed in the acute phase of coronary syndromes, the benefits observed with insulin therapy are probably due to the improvement of glycemic control, rather than to direct effects of insulin on the cardiovascular system. In long-term trials for primary or secondary prevention such as UKPDS and ORIGIN insulin has no relevant effects on major cardiovascular events beyond those determined by the improvement of metabolic control. On the other hand, severe hypoglycemia, which is a possible side effect of insulin therapy, is associated with a worse prognosis of cardiovascular disease. The availability of new long-acting insulin analogs, which reduce the incidence of hypoglycemia for similar levels of glycemic control, makes insulin therapy easier and potentially safer for the cardiovascular system.

  5. Patients’ preferences for selection of endpoints in cardiovascular clinical trials

    Directory of Open Access Journals (Sweden)

    Robert D. Chow

    2014-02-01

    Full Text Available Background: To reduce the duration and overall costs of cardiovascular trials, use of the combined endpoints in trial design has become commonplace. Though this methodology may serve the needs of investigators and trial sponsors, the preferences of patients or potential trial subjects in the trial design process has not been studied. Objective: To determine the preferences of patients in the design of cardiovascular trials. Design: Participants were surveyed in a pilot study regarding preferences among various single endpoints commonly used in cardiovascular trials, preference for single vs. composite endpoints, and the likelihood of compliance with a heart medication if patients similar to them participated in the trial design process. Participants: One hundred adult English-speaking patients, 38% male, from a primary care ambulatory practice located in an urban setting. Key results: Among single endpoints, participants rated heart attack as significantly more important than death from other causes (4.53 vs. 3.69, p=0.004 on a scale of 1–6. Death from heart disease was rated as significantly more important than chest pain (4.73 vs. 2.47, p<0.001, angioplasty/PCI/CABG (4.73 vs. 2.43, p<0.001, and stroke (4.73 vs. 2.43, p<0.001. Participants also expressed a slight preference for combined endpoints over single endpoint (43% vs. 57%, incorporation of the opinions of the study patient population into the design of trials (48% vs. 41% for researchers, and a greater likelihood of medication compliance if patient preferences were considered during trial design (67% indicated a significant to major effect. Conclusions: Patients are able to make judgments and express preferences regarding trial design. They prefer that the opinions of the study population rather than the general population be incorporated into the design of the study. This novel approach to study design would not only incorporate patient preferences into medical decision making, but

  6. Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo

    DEFF Research Database (Denmark)

    Bentley-Lewis, Rhonda; Aguilar, David; Riddle, Matthew C

    2015-01-01

    BACKGROUND: Cardiovascular (CV) disease is the leading cause of morbidity and mortality in patients with type 2 diabetes mellitus (T2DM). Furthermore, patients with T2DM and acute coronary syndrome (ACS) have a particularly high risk of CV events. The glucagon-like peptide 1 receptor agonist, lix...

  7. Educational intervention on cardiovascular parameters in perimenopausal women with a cardiovascular risk factor. Randomised clinical trial.

    Science.gov (United States)

    Soto Rodríguez, Anxela; García Soidán, José Luís; Arias Gómez, María Jesús; Del Álamo Alonso, Alberto; Leirós Rodríguez, Raquel; Pérez Fernández, María Reyes

    2018-03-09

    Randomised clinical trial performed in two urban health centres in Spain. To evaluate if educational intervention in women of perimenopausal age with hypertension, diabetes mellitus and/or dyslipidaemia could achieve significant changes in the reduction of biochemical and haemodynamic risk parameters. The study included 320 women aged between 45 and 60 years old who were diagnosed with hypertension, diabetes mellitus and/or dyslipidaemia. They were randomly assigned to the experimental group (n=160) and the control group (n=160). The intervention group received three educational sessions and the control group received an informative leaflet sent by mail. Haemodynamic and biochemical variables were evaluated at baseline and one year later in both groups. Women in the intervention group showed a decrease in low density lipoprotein (P=.034), (-5.89±29.8; 95% CI: -13.1/0.27) and an increase in high density lipoprotein (P=.013), (2.71±10.6; 95% CI: -1.36/6.20), as well as improvements in systolic blood pressure (P=.016), (-2.16±11.8; 95% CI: -4.4/0.01) and frequency (P=.003), (-1.46±10.3; 95% CI: -3.34/0.42) compared to women in the control group. Women in the control group significantly increased glucose (P=.04), (4.84±15.5; 95% CI: -0.75/31.3) and gamma-glutamyltranspeptidase (P=.031), (3.61±14.7; 95% CI: 0.87/6.36) levels more than those in the experimental group. An educational intervention can be an effective method of reducing the parameters associated with an increased likelihood of cardiovascular disease in women at perimenopausal age with hypertension, diabetes mellitus and/or dyslipidaemia. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

  8. Stem cell trials for cardiovascular medicine: ethical rationale.

    Science.gov (United States)

    Niemansburg, Sophie L; Teraa, Martin; Hesam, Husna; van Delden, Johannes J M; Verhaar, Marianne C; Bredenoord, Annelien L

    2014-10-01

    Stem cell-based interventions provide new treatment prospects for many disease conditions, including cardiovascular disorders. Clinical trials are necessary to collect adequate evidence on (long-term) safety and efficacy of novel interventions such as stem cells, but the design and launch of clinical trials, from first-in-human studies to larger randomized controlled trials (RCTs), is scientifically and ethically challenging. Stem cells are different from traditional pharmaceuticals, surgical procedures, and medical devices in the following ways: the novelty and complexity of stem cells, the invasiveness of the procedures, and the novel aim of regeneration. These specifics, combined with the characteristics of the study population, will have an impact on the design and ethics of RCTs. The recently closed JUVENTAS trial will serve as an example to identify the (interwoven) scientific and ethical challenges in the design and launch of stem cell RCTs. The JUVENTAS trial has investigated the efficacy of autologous bone marrow cells in end-stage vascular patients, in a double-blind sham-controlled design. We first describe the choices, considerations, and experiences of the JUVENTAS team. Subsequently, we identify the main ethical and scientific challenges and discuss what is important to consider in the design of future stem cell RCTs: assessment of risks and benefits, the choice for outcome measures, the choice for the comparator, the appropriate selection of participants, and adequate informed consent. Additionally, the stem cell field is highly in the spotlight due to the (commercial) interests and expectations. This warrants a cautious pace of translation and scrupulous set up of clinical trials, as failures could put the field in a negative light. At the same time, knowledge from clinical trials is necessary for the field to progress. We conclude that in the scientifically and ethically challenging field of stem cell RCTs, researchers and clinicians have to

  9. Kettlebell training for musculoskeletal and cardiovascular health: a randomized controlled trial

    DEFF Research Database (Denmark)

    Jay, Kenneth; Frisch, Dennis; Hansen, Klaus

    2011-01-01

    The aim of this trial was to investigate the effectiveness of a worksite intervention using kettlebell training to improve musculoskeletal and cardiovascular health.......The aim of this trial was to investigate the effectiveness of a worksite intervention using kettlebell training to improve musculoskeletal and cardiovascular health....

  10. Improving clinical trials for cardiovascular diseases: a position paper from the Cardiovascular Round Table of the European Society of Cardiology.

    Science.gov (United States)

    Jackson, Neville; Atar, Dan; Borentain, Maria; Breithardt, Günter; van Eickels, Martin; Endres, Matthias; Fraass, Uwe; Friede, Tim; Hannachi, Hakima; Janmohamed, Salim; Kreuzer, Jörg; Landray, Martin; Lautsch, Dominik; Le Floch, Chantal; Mol, Peter; Naci, Huseyin; Samani, Nilesh J; Svensson, Anders; Thorstensen, Cathrine; Tijssen, Jan; Vandzhura, Victoria; Zalewski, Andrew; Kirchhof, Paulus

    2016-03-01

    Cardiovascular disease is the most common cause of mortality and morbidity in the world, but the pharmaceutical industry's willingness to invest in this field has declined because of the many challenges involved with bringing new cardiovascular drugs to market, including late-stage failures, escalating regulatory requirements, bureaucracy of the clinical trial business enterprise, and limited patient access after approval. This contrasts with the remaining burden of cardiovascular disease in Europe and in the world. Thus, clinical cardiovascular research needs to adapt to address the impact of these challenges in order to ensure development of new cardiovascular medicines. The present paper is the outcome of a two-day workshop held by the Cardiovascular Round Table of the European Society of Cardiology. We propose strategies to improve development of effective new cardiovascular therapies. These can include (i) the use of biomarkers to describe patients who will benefit from new therapies more precisely, achieving better human target validation; (ii) targeted, mechanism-based approaches to drug development for defined populations; (iii) the use of information technology to simplify data collection and follow-up in clinical trials; (iv) streamlining adverse event collection and reducing monitoring; (v) extended patent protection or limited rapid approval of new agents to motivate investment in early phase development; and (vi) collecting data needed for health technology assessment continuously throughout the drug development process (before and after approval) to minimize delays in patient access. Collaboration across industry, academia, regulators, and payers will be necessary to enact change and to unlock the existing potential for cardiovascular clinical drug development. A coordinated effort involving academia, regulators, industry, and payors will help to foster better and more effective conduct of clinical cardiovascular trials, supporting earlier

  11. Comparison of cardiovascular magnetic resonance and single-photon emission computed tomography in women with suspected coronary artery disease from the Clinical Evaluation of Magnetic Resonance Imaging in Coronary Heart Disease (CE-MARC) Trial.

    Science.gov (United States)

    Greenwood, John P; Motwani, Manish; Maredia, Neil; Brown, Julia M; Everett, Colin C; Nixon, Jane; Bijsterveld, Petra; Dickinson, Catherine J; Ball, Stephen G; Plein, Sven

    2014-03-11

    Coronary artery disease is the leading cause of death in women, and underdiagnosis contributes to the high mortality. This study compared the sex-specific diagnostic performance of cardiovascular magnetic resonance (CMR) and single-photon emission computed tomography (SPECT). A total of 235 women and 393 men with suspected angina underwent CMR, SPECT, and x-ray angiography as part of the Clinical Evaluation of Magnetic Resonance Imaging in Coronary Heart Disease (CE-MARC) study. CMR comprised adenosine stress/rest perfusion, cine imaging, late gadolinium enhancement, and magnetic resonance coronary angiography. Gated adenosine stress/rest SPECT was performed with (99m)Tc-tetrofosmin. For CMR, the sensitivity in women and men was similar (88.7% versus 85.6%; P=0.57), as was the specificity (83.5% versus 82.8%; P=0.86). For SPECT, the sensitivity was significantly worse in women than in men (50.9% versus 70.8%; P=0.007), but the specificities were similar (84.1% versus 81.3%; P=0.48). The sensitivity in both the female and male groups was significantly higher with CMR than SPECT (Pwomen (area under the curve, 0.90 versus 0.67; Pmen (area under the curve, 0.89 versus 0.74; Paccuracy was similar in both sexes with perfusion CMR (P=1.00) but was significantly worse in women with SPECT (Pwomen with suspected coronary artery disease. http://www.controlled-trials.com. Unique identifier: ISRCTN77246133.

  12. Quantitative imaging biomarkers for the evaluation of cardiovascular complications in type 2 diabetes mellitus.

    Science.gov (United States)

    Lin, Kai; Lloyd-Jones, Donald M; Li, Debiao; Carr, James C

    2014-01-01

    Type 2 diabetes mellitus (T2DM) is a prevalent condition in aged populations. Cardiovascular diseases are leading causes of death and disability in patients with T2DM. Traditional strategies for controlling the cardiovascular complications of diabetes primarily target a cluster of well-defined risk factors, such as hyperglycemia, lipid disorders and hypertension. However, there is controversy over some recent clinical trials aimed at evaluating efficacy of intensive treatments for T2DM. As a powerful tool for quantitative cardiovascular risk estimation, multi-disciplinary cardiovascular imaging have been applied to detect and quantify morphological and functional abnormalities in the cardiovascular system. Quantitative imaging biomarkers acquired with advanced imaging procedures are expected to provide new insights to stratify absolute cardiovascular risks and reduce the overall costs of health care for people with T2DM by facilitating the selection of optimal therapies. This review discusses principles of state-of-the-art cardiovascular imaging techniques and compares applications of those techniques in various clinical circumstances. Individuals measurements of cardiovascular disease burdens from multiple aspects, which are closely related to existing biomarkers and clinical outcomes, are recommended as promising candidates for quantitative imaging biomarkers to assess the responses of the cardiovascular system during diabetic regimens. © 2013 Elsevier Inc. All rights reserved.

  13. Rational and design of a stepped-wedge cluster randomized trial evaluating quality improvement initiative for reducing cardiovascular events among patients with acute coronary syndromes in resource-constrained hospitals in China.

    Science.gov (United States)

    Li, Shenshen; Wu, Yangfeng; Du, Xin; Li, Xian; Patel, Anushka; Peterson, Eric D; Turnbull, Fiona; Lo, Serigne; Billot, Laurent; Laba, Tracey; Gao, Runlin

    2015-03-01

    Acute coronary syndromes (ACSs) are a major cause of morbidity and mortality, yet effective ACS treatments are frequently underused in clinical practice. Randomized trials including the CPACS-2 study suggest that quality improvement initiatives can increase the use of effective treatments, but whether such programs can impact hard clinical outcomes has never been demonstrated in a well-powered randomized controlled trial. The CPACS-3 study is a stepped-wedge cluster-randomized trial conducted in 104 remote level 2 hospitals without PCI facilities in China. All hospitalized ACS patients will be recruited consecutively over a 30-month period to an anticipated total study population of more than 25,000 patients. After a 6-month baseline period, hospitals will be randomized to 1 of 4 groups, and a 6-component quality improvement intervention will be implemented sequentially in each group every 6months. These components include the following: establishment of a quality improvement team, implementation of a clinical pathway, training of physicians and nurses, hospital performance audit and feedback, online technical support, and patient education. All patients will be followed up for 6months postdischarge. The primary outcome will be the incidence of in-hospital major adverse cardiovascular events comprising all-cause mortality, myocardial infarction or reinfarction, and nonfatal stroke. The CPACS-3 study will be the first large randomized trial with sufficient power to assess the effects of a multifaceted quality of care improvement initiative on hard clinical outcomes, in patients with ACS. Copyright © 2014 Elsevier Inc. All rights reserved.

  14. Community Outreach and Cardiovascular Health (COACH) Trial: a randomized, controlled trial of nurse practitioner/community health worker cardiovascular disease risk reduction in urban community health centers.

    Science.gov (United States)

    Allen, Jerilyn K; Dennison-Himmelfarb, Cheryl R; Szanton, Sarah L; Bone, Lee; Hill, Martha N; Levine, David M; West, Murray; Barlow, Amy; Lewis-Boyer, LaPricia; Donnelly-Strozzo, Mary; Curtis, Carol; Anderson, Katherine

    2011-11-01

    Despite well-publicized guidelines on the appropriate management of cardiovascular disease and type 2 diabetes, the implementation of risk-reducing practices remains poor. This report describes the results of a randomized, controlled clinical trial evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reduction delivered by nurse practitioner /community health worker (NP/CHW) teams versus enhanced usual care (EUC) to improve lipids, blood pressure, glycated hemoglobin (HbA1c), and patient perceptions of the quality of their chronic illness care in patients in urban community health centers. A total of 525 patients with documented cardiovascular disease, type 2 diabetes, hypercholesterolemia, or hypertension and levels of LDL cholesterol, blood pressure, or HbA1c that exceeded goals established by national guidelines were randomly assigned to NP/CHW (n=261) or EUC (n=264) groups. The NP/CHW intervention included aggressive pharmacological management and tailored educational and behavioral counseling for lifestyle modification and problem solving to address barriers to adherence and control. Compared with EUC, patients in the NP/CHW group had significantly greater 12-month improvement in total cholesterol (difference, 19.7 mg/dL), LDL cholesterol (difference,15.9 mg/dL), triglycerides (difference, 16.3 mg/dL), systolic blood pressure (difference, 6.2 mm Hg), diastolic blood pressure (difference, 3.1 mm Hg), HbA1c (difference, 0.5%), and perceptions of the quality of their chronic illness care (difference, 1.2 points). An intervention delivered by an NP/CHW team using individualized treatment regimens based on treat-to-target algorithms can be an effective approach to improve risk factor status and perceptions of chronic illness care in high-risk patients.

  15. Baseline characteristics in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT)

    DEFF Research Database (Denmark)

    Pfeffer, Marc A; Burdmann, Emmanuel A; Chen, Chao-Yin

    2009-01-01

    BACKGROUND: Anemia augments the already high rates of fatal and major nonfatal cardiovascular and renal events in individuals with type 2 diabetes. In 2004, we initiated the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT). This report presents the baseline characteristics and t...

  16. The women's heart health programme: a pilot trial of sex-specific cardiovascular management.

    Science.gov (United States)

    Low, Ting Ting; Chan, Siew Pang; Wai, Shin Hnin; Ang, Zhou; Kyu, Kyu; Lee, Kim Yee; Ching, Anne; Comer, Sarah; Tan, Naomi Qiu Pin; Thong, Elizabeth Grace Hui En; Nang, Tracy; Dutta, Mohan; Lam, Carolyn S P

    2018-04-16

    There is increasing knowledge of sex-specific differences in cardiovascular disease and recognition of sex disparities in management. In our study, we investigated whether a cardiovascular programme tailored to the specific needs of women could lead to improved outcomes. We randomised 100 female patients to receive cardiology follow-up with the conventional sex-neutral cardiac programme (control), or the sex-tailored Women's Heart Health Programme (intervention). The intervention group was managed by an all-women multidisciplinary team and received culture-centred health intervention workshops, designed through in-depth interviews with the participants. The primary outcome was cardiovascular risk factor improvement at 1 year. Secondary outcomes include cardiovascular event rates, quality of life scores, and self-reported improvement in knowledge, attitudes, intentions and practices. Generalised structural equation model analysis was used to determine if the intervention group had better outcomes at alpha level 0.1. The mean age was 67.3 ± 12.7 years, with an ethnic distribution of 70% Chinese, 18% Malays, and 12% Indians. The majority of these patients had no formal or primary level of education (63%), and were mostly unemployed (78%). Patients in intervention group had better control of diabetes mellitus (lower HbA1c of 0.63% [CI 0.21-1.04], p = 0.015) and lower body-mass-index (0.74 kg/m 2 [CI 0.02-1.46], p = 0.092) at 1 year, but there was no significant difference in blood pressure or lipid control. Overall, there was a trend towards better risk factor control, 31.6% of intervention group versus 26.5% of control group achieved improvement in at least 1 CV risk factor control to target range. There was no significant difference in incidence of cardiovascular events, quality of life, or domains in knowledge, attitudes, intention and practices. This pilot study is the first of its kind evaluating a new model of care for women with heart disease

  17. Evaluation of Cardiovascular Risk Scores Applied to NASA's Astronant Corps

    Science.gov (United States)

    Jain, I.; Charvat, J. M.; VanBaalen, M.; Lee, L.; Wear, M. L.

    2014-01-01

    In an effort to improve cardiovascular disease (CVD) risk prediction, this analysis evaluates and compares the applicability of multiple CVD risk scores to the NASA Astronaut Corps which is extremely healthy at selection.

  18. Relationships of different types of event to cardiovascular death in trials of antihypertensive treatment: an aid to definition of total cardiovascular disease risk in hypertension.

    Science.gov (United States)

    Zambon, Antonella; Arfè, Andrea; Corrao, Giovanni; Zanchetti, Alberto

    2014-03-01

    Guidelines for management of cardiovascular diseases stratify absolute cardiovascular risk into categories with a high-risk threshold defined at a 20% cardiovascular events risk in 10 years, but it is unclear whether only major events or the Framingham-extended definition should be considered. The 2013 ESH-ESC hypertension guidelines, instead, define cardiovascular risk as a risk of cardiovascular death in 10 years, as in the SCORE model, setting the threshold for high risk at the 5% level. It would be therefore convenient to know the quantitative relationship between the risks of the different outcomes adopted by the different guidelines, especially because some outcome definitions include serious nonfatal cardiovascular events relevant in cardiovascular prevention. We have therefore analysed these relationships in trials of antihypertensive therapy as an aid to defining total cardiovascular risk in hypertensive patients. Sixty-one trials were identified, and 51 retained for analysis of the relationship of cardiovascular death to the incidence of all-cause death, major cardiovascular events and inclusive (Framingham) cardiovascular events. The relationship between cardiovascular death rates and each type of event rates was explored by fitting flexible regression models. The included trials provided 15164 cardiovascular deaths and 1674427 patient-years. The relation of each event rate to cardiovascular death rate was best explained by a model considering the logarithm of each event rate as a dependent variable and the logarithm of cardiovascular death rate as a predictor. Mean patients' age and treatment were also predictors, but to a minor extent. The increase of the incidence rates of all types of events was less steep the higher the CV death rate: the rate ratios of all-cause death to cardiovascular death were 2.2, 1.9 and 1.8 at low-moderate (cardiovascular death hypertensive patients whose cardiovascular death risk is calculated by the SCORE model.

  19. Design, history and results of the Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) randomised controlled trial

    DEFF Research Database (Denmark)

    Punthakee, Z; Bosch, J; Dagenais, G

    2012-01-01

    AIMS/OBJECTIVE: Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial. The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs (rosiglit......AIMS/OBJECTIVE: Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial. The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs...

  20. A problem-solving intervention for cardiovascular disease risk reduction in veterans: Protocol for a randomized controlled trial.

    Science.gov (United States)

    Nieuwsma, Jason A; Wray, Laura O; Voils, Corrine I; Gierisch, Jennifer M; Dundon, Margaret; Coffman, Cynthia J; Jackson, George L; Merwin, Rhonda; Vair, Christina; Juntilla, Karen; White-Clark, Courtney; Jeffreys, Amy S; Harris, Amy; Owings, Michael; Marr, Johnpatrick; Edelman, David

    2017-09-01

    Health behaviors related to diet, tobacco usage, physical activity, medication adherence, and alcohol use are highly determinative of risk for developing cardiovascular disease. This paper describes a study protocol to evaluate a problem-solving intervention that aims to help patients at risk for developing cardiovascular disease address barriers to adopting positive health behaviors in order to reduce cardiovascular risk. Eligible patients are adults enrolled in Veterans Affairs (VA) health care who have not experienced a cardiovascular event but are at elevated risk based on their Framingham Risk Score (FRS). Participants in this two-site study are randomized to either the intervention or care as usual, with a target of 400 participants. The study intervention, Healthy Living Problem-Solving (HELPS), consists of six group sessions conducted approximately monthly interspersed with individualized coaching calls to help participants apply problem-solving principles. The primary outcome is FRS, analyzed at the beginning and end of the study intervention (6months). Participants also complete measures of physical activity, caloric intake, self-efficacy, group cohesion, problem-solving capacities, and demographic characteristics. Results of this trial will inform behavioral interventions to change health behaviors in those at risk for cardiovascular disease and other health conditions. ClinicalTrials.gov identifier NCT01838226. Published by Elsevier Inc.

  1. Cardiovascular System Sonographic Evaluation Algorithm: A New Sonographic Algorithm for Evaluation of the Fetal Cardiovascular System in the Second Trimester.

    Science.gov (United States)

    De León-Luis, Juan; Bravo, Coral; Gámez, Francisco; Ortiz-Quintana, Luis

    2015-07-01

    To evaluate the reproducibility and feasibility of the new cardiovascular system sonographic evaluation algorithm for studying the extended fetal cardiovascular system, including the portal, thymic, and supra-aortic areas, in the second trimester of pregnancy (19-22 weeks). We performed a cross-sectional study of pregnant women with healthy fetuses (singleton and twin pregnancies) attending our center from March to August 2011. The extended fetal cardiovascular system was evaluated by following the new algorithm, a sequential acquisition of axial views comprising the following (caudal to cranial): I, portal sinus; II, ductus venosus; III, hepatic veins; IV, 4-chamber view; V, left ventricular outflow tract; VI, right ventricular outflow tract; VII, 3-vessel and trachea view; VIII, thy-box; and IX, subclavian arteries. Interobserver agreement on the feasibility and exploration time was estimated in a subgroup of patients. The feasibility and exploration time were determined for the main cohort. Maternal, fetal, and sonographic factors affecting both features were evaluated. Interobserver agreement was excellent for all views except view VIII; the difference in the mean exploration time between observers was 1.5 minutes (95% confidence interval, 0.7-2.1 minutes; P cardiovascular system sonographic evaluation algorithm is a reproducible and feasible approach for exploration of the extended fetal cardiovascular system in a second-trimester scan. It can be used to explore these areas in normal and abnormal conditions and provides an integrated image of extended fetal cardiovascular anatomy. © 2015 by the American Institute of Ultrasound in Medicine.

  2. Comparative trials in registration files of cardiovascular drugs : Comparator drugs and dosing schemes.

    NARCIS (Netherlands)

    Wieringa, NF; Vos, R; de Graeff, PA

    Registration files of 13 cardiovascular drugs were analysed with respect to the number of double-blind phase-III clinical trials, the use of placebo and active comparator drugs and their dosing schemes. Half of the 146 double-blind trials used active comparator drugs. The majority of files included

  3. Evaluation of the electromechanical properties of the cardiovascular system

    Science.gov (United States)

    Bergman, S. A., Jr.; Hoffler, G. W.; Johnson, R. L.

    1974-01-01

    Cardiovascular electromechanical measurements were collected on returning Skylab crewmembers at rest and during both lower body negative pressure and exercise stress testing. These data were compared with averaged responses from multiple preflight tests. Systolic time intervals and first heart sound amplitude changes were measured. Clinical cardiovascular examinations and clinical phonocardiograms were evaluated. All changes noted returned to normal within 30 days postflight so that the processes appear to be transient and self limited. The cardiovascular system seems to adapt quite readily to zero-g, and more importantly it is capable of readaptation to one-g after long duration space flight. Repeated exposures to zero-g also appear to have no detrimental effects on the cardiovascular system.

  4. Cardiovascular benefits from ancient grain bread consumption: findings from a double-blinded randomized crossover intervention trial.

    Science.gov (United States)

    Sereni, Alice; Cesari, Francesca; Gori, Anna Maria; Maggini, Niccolò; Marcucci, Rossella; Casini, Alessandro; Sofi, Francesco

    2017-02-01

    Ancient grain varieties have been shown to have some beneficial effects on health. Forty-five clinically healthy subjects were included in a randomized, double-blinded crossover trial aimed at evaluating the effect of a replacement diet with bread derived from ancient grain varieties versus modern grain variety on cardiovascular risk profile. After 8 weeks of intervention, consumption of bread obtained by the ancient varieties showed a significant amelioration of various cardiovascular parameters. Indeed, the ancient varieties were shown to result in a significant reduction of total cholesterol, low-density lipoprotein (LDL)-cholesterol and blood glucose, whereas no significant differences during the phase with the modern variety were reported. Moreover, a significant increase in circulating endothelial progenitor cells were reported after the consumption of products made from the ancient "Verna" variety. The present results suggest that a dietary consumption of bread obtained from ancient grain varieties was effective in reducing cardiovascular risk factors.

  5. Effects of a Mediterranean-style diet on cardiovascular risk factors: a randomized trial.

    Science.gov (United States)

    Estruch, Ramon; Martínez-González, Miguel Angel; Corella, Dolores; Salas-Salvadó, Jordi; Ruiz-Gutiérrez, Valentina; Covas, María Isabel; Fiol, Miguel; Gómez-Gracia, Enrique; López-Sabater, Mari Carmen; Vinyoles, Ernest; Arós, Fernando; Conde, Manuel; Lahoz, Carlos; Lapetra, José; Sáez, Guillermo; Ros, Emilio

    2006-07-04

    The Mediterranean diet has been shown to have beneficial effects on cardiovascular risk factors. To compare the short-term effects of 2 Mediterranean diets versus those of a low-fat diet on intermediate markers of cardiovascular risk. Substudy of a multicenter, randomized, primary prevention trial of cardiovascular disease (Prevención con Dieta Mediterránea [PREDIMED] Study). Primary care centers affiliated with 10 teaching hospitals. 772 asymptomatic persons 55 to 80 years of age at high cardiovascular risk who were recruited from October 2003 to March 2004. Participants were assigned to a low-fat diet (n = 257) or to 1 of 2 Mediterranean diets. Those allocated to Mediterranean diets received nutritional education and either free virgin olive oil, 1 liter per week (n = 257), or free nuts, 30 g/d (n = 258). The authors evaluated outcome changes at 3 months. Body weight, blood pressure, lipid profile, glucose levels, and inflammatory molecules. The completion rate was 99.6%. Compared with the low-fat diet, the 2 Mediterranean diets produced beneficial changes in most outcomes. Compared with the low-fat diet, the mean changes in the Mediterranean diet with olive oil group and the Mediterranean diet with nuts group were -0.39 mmol/L (95% CI, -0.70 to -0.07 mmol/L) and -0.30 mmol/L (CI, -0.58 to -0.01 mmol/L), respectively, for plasma glucose levels; -5.9 mm Hg (CI, -8.7 to -3.1 mm Hg) and -7.1 mm Hg (CI, -10.0 to -4.1 mm Hg), respectively, for systolic blood pressure; and -0.38 (CI, -0.55 to -0.22) and - 0.26 (CI, -0.42 to -0.10), respectively, for the cholesterol-high-density lipoprotein cholesterol ratio. The Mediterranean diet with olive oil reduced C-reactive protein levels by 0.54 mg/L (CI, 1.04 to 0.03 mg/L) compared with the low-fat diet. This short-term study did not focus on clinical outcomes. Nutritional education about low-fat diet was less intense than education about Mediterranean diets. Compared with a low-fat diet, Mediterranean diets supplemented

  6. Cardiovascular risk assessment in the treatment of nonalcoholic steatohepatitis: a secondary analysis of the MOZART trial.

    Science.gov (United States)

    Lin, Steven C; Ang, Brandon; Hernandez, Carolyn; Bettencourt, Ricki; Jain, Rashmi; Salotti, Joanie; Richards, Lisa; Kono, Yuko; Bhatt, Archana; Aryafar, Hamed; Lin, Grace Y; Valasek, Mark A; Sirlin, Claude B; Brouha, Sharon; Loomba, Rohit

    2016-03-01

    Nonalcoholic steatohepatitis (NASH) is associated with increased cardiovascular risk and mortality. No US Food and Drug Administration (FDA) approved therapies for NASH are available; clinical trials to date have not yet systematically assessed for changes in cardiovascular risk. This study examines the prospective utility of cardiovascular risk assessments, the Framingham risk score (FRS) and coronary artery calcium (CAC) score, as endpoints in a NASH randomized clinical trial, and assesses whether histologic improvements lead to lower cardiovascular risk. Secondary analysis of a 24-week randomized, double-blind, placebo-controlled trial (MOZART) in which 50 biopsy-proven NASH patients received oral ezetimibe 10 mg daily (n = 25) versus placebo (n = 25). Biochemical profiling, FRS, CAC scores, liver biopsies were obtained at baseline and endpoint. Ezetimibe improved FRS whereas placebo did not (4.4 ± 6.2 to 2.9 ± 4.8, p = 0.038; 3.0 ± 4.4 to 2.9 ± 4.2, p = 0.794). CAC scores did not change with ezetimibe or placebo (180.4 ± 577.2 to 194.1 ± 623.9, p = 0.293; 151.4 ± 448.9 to 183.3 ± 555.7, p = 0.256). Ezetimibe improved FRS and CAC scores in more patients than placebo (48% versus 23%, p = 0.079, and 21% versus 0%, p = 0.090, respectively), though not significantly. No differences were noted in cardiovascular risk scores among histologic responders versus nonresponders. Ezetimibe improved FRS whereas placebo did not. FRS and CAC scores improved in a greater proportion of patients with ezetimibe; this trend did not reach significance. These findings indicate the utility and feasibility of monitoring cardiovascular risk in a NASH trial. The utility of CAC scores may be higher in trials of longer duration (⩾52 weeks) and with older patients (age ⩾45). ClinicalTrials.gov registration: NCT01766713.

  7. Filtration Markers, Cardiovascular Disease, Mortality, and Kidney Outcomes in Stable Kidney Transplant Recipients: The FAVORIT Trial.

    Science.gov (United States)

    Foster, M C; Weiner, D E; Bostom, A G; Carpenter, M A; Inker, L A; Jarolim, P; Joseph, A A; Kusek, J W; Pesavento, T; Pfeffer, M A; Rao, M; Solomon, S D; Levey, A S

    2017-09-01

    Cystatin C and beta-2-microglobulin (B2M) are filtration markers associated with adverse outcomes in nontransplant populations, sometimes with stronger associations than for creatinine. We evaluated associations of estimated glomerular filtration rate from cystatin C (eGFR cys ), B2M (eGFR B 2M ), and creatinine (eGFR cr ) with cardiovascular outcomes, mortality, and kidney failure in stable kidney transplant recipients using a case-cohort study nested within the Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) Trial. A random subcohort was selected (N = 508; mean age 51.6 years, median transplant vintage 4 years, 38% women, 23.6% nonwhite race) with enrichment for cardiovascular events (N = 306; 54 within the subcohort), mortality (N = 208; 68 within the subcohort), and kidney failure (N = 208; 52 within the subcohort). Mean eGFR cr , eGFR cys , and eGFR B 2M were 46.0, 43.8, and 48.8 mL/min/1.73m 2 , respectively. After multivariable adjustment, hazard ratios for eGFR cys and eGFR B 2M mortality; and 9.49 (4.28-21.00) and 15.53 (6.99-34.51; both p mortality, and kidney failure in stable kidney transplant recipients. © 2017 The American Society of Transplantation and the American Society of Transplant Surgeons.

  8. Evaluation of cardiovascular effects of edible fruits of Syzygium ...

    African Journals Online (AJOL)

    Evaluation of cardiovascular effects of edible fruits of Syzygium cumini Myrtaceae (L) skeels in rats. EA Herculano, C da Costa, AKBF Rodriques, JX Araújo-Júnior, EG Santana, PHB França, EA Gomes, MJ Salvador, FBP Moura, EAN Ribeiro ...

  9. Rationale and design of the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) trial.

    Science.gov (United States)

    Holman, Rury R; Bethel, Mary Angelyn; George, Jyothis; Sourij, Harald; Doran, Zoë; Keenan, Joanne; Khurmi, Nardev S; Mentz, Robert J; Oulhaj, Abderrahim; Buse, John B; Chan, Juliana C; Iqbal, Nayyar; Kundu, Sudeep; Maggioni, Aldo P; Marso, Steven P; Öhman, Peter; Pencina, Michael J; Poulter, Neil; Porter, Lisa E; Ramachandran, Ambady; Zinman, Bernard; Hernandez, Adrian F

    2016-04-01

    Exenatide once-weekly is an extended release formulation of exenatide, a glucagon-like peptide-1 receptor agonist, which can improve glycemic control, body weight, blood pressure, and lipid levels in patients with type 2 diabetes mellitus (T2DM). The EXenatide Study of Cardiovascular Event Lowering (EXSCEL) will compare the impact of adding exenatide once-weekly to usual care with usual care alone on major cardiovascular outcomes. EXSCEL is an academically led, phase III/IV, double-blind, pragmatic placebo-controlled, global trial conducted in 35 countries aiming to enrol 14,000 patients with T2DM and a broad range of cardiovascular risk over approximately 5 years. Participants will be randomized (1:1) to receive exenatide once-weekly 2 mg or matching placebo by subcutaneous injections. The trial will continue until 1,360 confirmed primary composite cardiovascular end points, defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, have occurred. The primary efficacy hypothesis is that exenatide once-weekly is superior to usual care with respect to the primary composite cardiovascular end point. EXSCEL is powered to detect a 15% relative risk reduction in the exenatide once-weekly group, with 85% power and a 2-sided 5% alpha. The primary safety hypothesis is that exenatide once-weekly is noninferior to usual care with respect to the primary cardiovascular composite end point. Noninferiority will be concluded if the upper limit of the CI is events in patients with T2DM with a broad range of cardiovascular risk. It will also provide long-term safety information on exenatide once-weekly in people with T2DM. ClinicalTrials.gov Identifier: NCT01144338. Copyright © 2015 Elsevier Inc. All rights reserved.

  10. A review of renal, cardiovascular and mortality endpoints in antihypertensive trials in diabetic patients.

    Science.gov (United States)

    García-Donaire, J A; Segura, J; Cerezo, C; Ruilope, L M

    2011-12-01

    Renal disease is highly prevalent in people with type 2 diabetes, and co-existence with hypertension increases the risk of cardiac events and mortality. Despite many large randomized trials, controversies remain regarding optimal antihypertensive therapy in diabetic patients, including whether some classes of antihypertensive drugs have specific renal protective properties, and the relationships between renal, cardiovascular and mortality endpoints. In this article, we review landmark antihypertensive drug trials from the last two decades in patient populations composed, or including substantial proportions, of patients with type 2 diabetes. Several points emerge. Firstly, treatment effects can vary widely among different renal, cardiovascular and mortality endpoints. Secondly, combinations of antihypertensive drugs vary in their ability to prevent major renal and cardiovascular events, even if they produce similar reductions in blood pressure. Thirdly, simply adding further antihypertensive drugs may not improve outcomes, even if it produces further reductions in blood pressure. In most trials, a reduction in microalbuminuria was associated with evidence of renal protection, but further evidence is needed relating changes in proteinuria with cardiovascular risk. The study that aligns best with the current reappraisal of ESH guidelines, with regard to blood pressure goals, use of an adequate combination and simultaneously protecting the kidney and the cardiovascular system, is the ADVANCE study.

  11. Co-morbidity of 'clinical trial' versus 'real-world' patients using cardiovascular drugs

    NARCIS (Netherlands)

    Wieringa, N.F.; Vos, Reinder; van der Werf, G.T.; van der Veen, W.J.; de Graeff, P.A.

    2000-01-01

    Purpose - To examine discrepancies between co-morbidity of patients included in pre marketing clinical trials of cardiovascular drugs and patients from daily practice, representing the actual users after marketing, and to investigate the availability of data regarding co-morbidity in registration

  12. Association between baseline vitamin D metabolite levels and long-term cardiovascular events in patients with rheumatoid arthritis from the CIMESTRA trial

    DEFF Research Database (Denmark)

    Herly, Mette; Stengaard-Pedersen, Kristian; Hørslev-Petersen, Kim

    2017-01-01

    event in the follow-up period, evaluated using systematic journal audits. Logistic regression models will test the hypothesis that there are more cardiovascular events in enrolled patients with a low level of vitamin D (..., it is relevant to take into account in a prediction model, to be considered by patients, physicians and other decision-makers. TRIAL REGISTRATION NUMBER: The parental controlled trial is registered as NCT00209859....

  13. Cardiovascular exercise training extends influenza vaccine seroprotection in sedentary older adults: the immune function intervention trial.

    Science.gov (United States)

    Woods, Jeffrey A; Keylock, K Todd; Lowder, Thomas; Vieira, Victoria J; Zelkovich, William; Dumich, Sara; Colantuano, Kim; Lyons, Kristin; Leifheit, Kurt; Cook, Marc; Chapman-Novakofski, Karen; McAuley, Edward

    2009-12-01

    To determine whether cardiovascular exercise training resulted in improved antibody responses to influenza vaccination in sedentary elderly people who exhibited poor vaccine responses. Single-site randomized parallel-arm 10-month controlled trial. University of Illinois at Urbana-Champaign. One hundred forty-four sedentary, healthy older (69.9 +/- 0.4) adults. Moderate (60-70% maximal oxygen uptake) cardiovascular exercise was compared with flexibility and balance training. The primary outcome was influenza vaccine response, as measured according to hemagglutination inhibition (HI) anti-influenza antibody titer and seroprotective responses (HI titer > or =40). Secondary measures included cardiovascular fitness and body composition. Of the 160 participants enrolled, 144 (90%) completed the 10-month intervention with excellent compliance ( approximately 83%). Cardiovascular, but not flexibility, exercise intervention resulted in improvements in indices of cardiovascular fitness, including maximal oxygen uptake. Although not affecting peak (e.g., 3 and 6 weeks) postvaccine anti-influenza HI titers, cardiovascular exercise resulted in a significant increase in seroprotection 24 weeks after vaccination (30-100% dependent on vaccine variant), whereas flexibility training did not. Participants randomized to cardiovascular exercise experienced improvements in influenza seroprotection throughout the entire influenza season, whereas those in the balance and flexibility intervention did not. Although there were no differences in reported respiratory tract infections, the exercise group exhibited reduced overall illness severity and sleep disturbance. These data support the hypothesis that regular endurance exercise improves influenza vaccine responses.

  14. Berberine: metabolic and cardiovascular effects in preclinical and clinical trials

    Directory of Open Access Journals (Sweden)

    Arrigo FG Cicero

    2009-09-01

    Full Text Available Arrigo FG Cicero1, Sibel Ertek21Internal Medicine, Aging and Kidney Diseases Department, Sant’Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; 2Ufuk University, Medical Faculty, Dr Ridvan Ege Hospital, Department of Endocrinology and Metabolic Diseases, Ankara, TurkeyAbstract: Berberine is a plant alkaloid with numerous biological activities. A large body of preclinical in vitro and in vivo studies support different pharmacological actions of berberine that could be potentially useful in the management of metabolic diseases associated with high cardiovascular disease risk, such as mixed hyperlipidemia, insulin resistance, metabolic syndrome, and type 2 diabetes. Moreover, it seems that berberine also exerts anti-inflammatory and antiproliferative effects that could play a role in the development of atherosclerosis and its clinical consequences. Recently, the metabolic effects of berberine have been demonstrated in humans, opening new perspectives for the use of this molecule in patient therapy. Larger and longer clinical studies need to be carried out to implement the definition of the therapeutic role of berberine in humans.Keywords: berberine, cardiovascular disease, diabetes, cholesterol

  15. Cluster-Randomized Trial of Clinical Pharmacist Tobacco Cessation Counseling Among Patients with Cardiovascular Disease.

    Science.gov (United States)

    Adams, Jody; Cymbala, Alicia A; Delate, Thomas; Kurz, Deanna; Olson, Kari L; Youngblood, Morgan; Zadvorny, Emily

    2015-08-01

    Optimal management of patients with cardiovascular disease (CVD) includes evaluation of risk factors using a team-based approach. Tobacco use often receives less attention than other CVD risk factors; therefore, utilization of nonphysician health care providers may be valuable in addressing tobacco use. The purpose of this trial was to assess the impact of brief, structured, telephone tobacco cessation counseling (BST) delivered by clinical pharmacists on tobacco cessation attempts compared to usual care. The BST consisted of 1 to 5 minutes discussing 3 key counseling points, including a recommendation to quit and education about cessation aids. This was a cluster-randomized trial of tobacco-using patients with CVD who were enrolled in a clinical pharmacist-managed, physician-directed, CVD disease state management service. Clinical pharmacists were randomized to provide usual care (control) or BST (intervention) to their tobacco-using patients during a 4-month period. Patients were surveyed 3 months later to assess their tobacco cessation attempts, use of tobacco cessation aids, and self-reported cessation. One hundred twenty patients were enrolled. Subjects were predominately white males, aged ≥65 years, with a history of myocardial infarction. One hundred and four subjects completed the follow-up survey. No differences were detected between the 36.2% and 38.6% of control and intervention subjects, respectively, reporting a tobacco cessation attempt (P=0.804) or in the other outcomes (all P>0.05). A BST delivered by clinical pharmacists may not adequately affect patient motivation enough to increase tobacco cessation attempts in tobacco-dependent patients with CVD. Future research is needed to evaluate other team-based strategies that can decrease tobacco use in patients with CVD.

  16. Ginseng and Ginkgo Biloba Effects on Cognition as Modulated by Cardiovascular Reactivity: A Randomised Trial.

    Science.gov (United States)

    Ong Lai Teik, Derek; Lee, Xiao Shiang; Lim, Chu Jian; Low, Chia Mei; Muslima, Mariyam; Aquili, Luca

    2016-01-01

    There is some evidence to suggest that ginseng and Ginkgo biloba can improve cognitive performance, however, very little is known about the mechanisms associated with such improvement. Here, we tested whether cardiovascular reactivity to a task is associated with cognitive improvement. Using a double-blind, placebo controlled, crossover design, participants (N = 24) received two doses of Panax Ginseng (500, 1000 mg) or Ginkgo Biloba (120, 240 mg) (N = 24), and underwent a series of cognitive tests while systolic, diastolic, and heart rate readings were taken. Ginkgo Biloba improved aspects of executive functioning (Stroop and Berg tasks) in females but not in males. Ginseng had no effect on cognition. Ginkgo biloba in females reversed the initial (i.e. placebo) increase in cardiovascular reactivity (systolic and diastolic readings increased compared to baseline) to cognitive tasks. This effect (reversal) was most notable after those tasks (Stroop and Iowa) that elicited the greatest cardiovascular reactivity during placebo. In males, although ginkgo also decreased cardiovascular readings, it did so from an initial (placebo) blunted response (i.e. decrease or no change from baseline) to cognitive tasks. Ginseng, on the contrary, increased cardiovascular readings compared to placebo. These results suggest that cardiovascular reactivity may be a mechanism by which ginkgo but not ginseng, in females is associated with certain forms of cognitive improvement. ClinicalTrials.gov NCT02386852.

  17. Centralized adjudication of cardiovascular end points in cardiovascular and noncardiovascular pharmacologic trials: a report from the Cardiac Safety Research Consortium.

    Science.gov (United States)

    Seltzer, Jonathan H; Turner, J Rick; Geiger, Mary Jane; Rosano, Giuseppe; Mahaffey, Kenneth W; White, William B; Sabol, Mary Beth; Stockbridge, Norman; Sager, Philip T

    2015-02-01

    This white paper provides a summary of presentations and discussions at a cardiovascular (CV) end point adjudication think tank cosponsored by the Cardiac Safety Research Committee and the US Food and Drug Administration (FDA) that was convened at the FDA's White Oak headquarters on November 6, 2013. Attention was focused on the lack of clarity concerning the need for end point adjudication in both CV and non-CV trials: there is currently an absence of widely accepted academic or industry standards and a definitive regulatory policy on how best to structure and use clinical end point committees (CECs). This meeting therefore provided a forum for leaders in the fields of CV clinical trials and CV safety to develop a foundation of initial best practice recommendations for use in future CEC charters. Attendees included representatives from pharmaceutical companies, regulatory agencies, end point adjudication specialist groups, clinical research organizations, and active, academically based adjudicators. The manuscript presents recommendations from the think tank regarding when CV end point adjudication should be considered in trials conducted by cardiologists and by noncardiologists as well as detailing key issues in the composition of a CEC and its charter. In addition, it presents several recommended best practices for the establishment and operation of CECs. The science underlying CV event adjudication is evolving, and suggestions for additional areas of research will be needed to continue to advance this science. This manuscript does not constitute regulatory guidance. Copyright © 2014 Elsevier Inc. All rights reserved.

  18. Evaluating a decision making system for cardiovascular dysautonomias diagnosis.

    Science.gov (United States)

    Idri, Ali; Kadi, Ilham

    2016-01-01

    Autonomic nervous system (ANS) is the part of the nervous system that is involved in homeostasis of the whole body functions. A malfunction in this system can lead to a cardiovascular dysautonomias. Hence, a set of dynamic tests are adopted in ANS units to diagnose and treat patients with cardiovascular dysautonomias. The purpose of this study is to develop and evaluate a decision tree based cardiovascular dysautonomias prediction system on a dataset collected from the ANS unit of the Moroccan university hospital Avicenne. We collected a dataset of 263 records from the ANS unit of the Avicenne hospital. This dataset was split into three subsets: training set (123 records), test set (55 records) and validation set (85 records). C4.5 decision tree algorithm was used in this study to develop the prediction system. Moreover, Java Enterprise Edition platform was used to implement a prototype of the developed system which was deployed in the Avicenne ANS unit so as to be clinically validated. The performance of the decision tree-based prediction system was evaluated by means of the error rate criterion. The error rates were measured for each classifier and have achieved an average value of 1.46, 2.24 and 0.89 % in training, test, and validation sets respectively. The results obtained were encouraging but further replicated studies are still needed to be performed in order to confirm the findings of this study.

  19. Evaluation of the cardiovascular effects of varenicline in rats

    Directory of Open Access Journals (Sweden)

    Selçuk EB

    2015-10-01

    prolongation was statistically significant in both the control and acute varenicline groups. Caspase-9 activity was also significantly increased by chronic exposure. Moreover, histopathological observations revealed severe morphological heart damage in both groups.Conclusion: Adverse effects of chronic varenicline exposure on cardiovascular tissue were confirmed by our electrocardiographic, biochemical, and histopathological analyses. This issue needs to be investigated with new experimental and clinical studies to evaluate the exact mechanism(s of the detrimental effects of varenicline. Physicians should bear in mind the toxic effects of varenicline on the cardiovascular system when prescribing it for smoking cessation.Keywords: varenicline, smoking, cardiovascular, rat, electrocardiogram, histopathological evaluation

  20. Oral disease and subsequent cardiovascular disease in people with type 2 diabetes: a prospective cohort study based on the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified-Release Controlled Evaluation (ADVANCE) trial.

    NARCIS (Netherlands)

    Li, Q.; Chalmers, J.; Czernichow, S.; Neal, B.; Taylor, B.A.; Zoungas, S.; Poulter, N.; Woodward, M.; Patel, A.; Galan, B.E. de; Batty, G.D.

    2010-01-01

    AIMS/HYPOTHESIS: While there are plausible biological mechanisms linking oral health with cardiovascular disease (CVD) and mortality rates, no study, to our knowledge, has examined this association in a representative population of people with type 2 diabetes. METHODS: We used the Action in Diabetes

  1. COACH trial: a randomized controlled trial of nurse practitioner/community health worker cardiovascular disease risk reduction in urban community health centers: rationale and design.

    Science.gov (United States)

    Allen, Jerilyn K; Himmelfarb, Cheryl R Dennison; Szanton, Sarah L; Bone, Lee; Hill, Martha N; Levine, David M

    2011-05-01

    Despite well-publicized guidelines on the appropriate management of cardiovascular disease (CVD) and type 2 diabetes, implementation of risk-reducing practices remains poor. This paper describes the rationale and design of a randomized controlled clinical trial evaluating the effectiveness of a comprehensive program of CVD risk reduction delivered by nurse practitioner (NP)/community health worker (CHW) teams versus enhanced usual care in improving the proportion of patients in urban community health centers who achieve goal levels recommended by national guidelines for lipids, blood pressure, HbA1c and prescription of appropriate medications. The COACH (Community Outreach and Cardiovascular Health) trial is a randomized controlled trial in which patients at federally-qualified community health centers were randomly assigned to one of two groups: comprehensive intensive management of CVD risk factors for one year by a NP/CHW team or an enhanced usual care control group. A total of 3899 patients were assessed for eligibility and 525 were randomized. Groups were comparable at baseline on sociodemographic and clinical characteristics with the exception of statistically significant differences in total cholesterol and hemoglobin A1c. This study is a novel amalgam of multilevel interdisciplinary strategies to translate highly efficacious therapies to low-income federally-funded health centers that care for patients who carry a disproportionate burden of CVD, type 2 diabetes and uncontrolled CVD risk factors. The impact of such a community clinic-based intervention is potentially enormous. Copyright © 2011 Elsevier Inc. All rights reserved.

  2. A systematic review of event rates in clinical trials in diabetes mellitus: the importance of quantifying baseline cardiovascular disease history and proteinuria and implications for clinical trial design.

    Science.gov (United States)

    Preiss, David; Sattar, Naveed; McMurray, John J

    2011-01-01

    Food and Drug Administration guidance now proposes that cardiovascular safety of new diabetes medicines be demonstrated. Consequently, trials should include a sufficient number of individuals with diabetes who are at high cardiovascular risk. We aimed to examine the impact of the presence of baseline cardiovascular disease and proteinuria, as binary criteria, on cardiovascular event rates in diabetes trials and to examine whether predicted primary end-point event rates are achieved. we searched Medline and EMBASE English language records (January 1998-June 2010) for randomized controlled trials of antiplatelet, lipid-lowering, antihypertensive, and glucose-lowering agents with >1,000 diabetic subjects reporting at least one of all-cause death, cardiovascular death, myocardial infarction, and stroke. Weighted mean event rates (events/1,000 patient-years) were calculated. Data from published power calculations were also compared with achieved event rates. twenty-nine trials met inclusion criteria. Weighted mean event rates in diabetic subjects with and those without baseline cardiovascular disease were, respectively, 28.9 and 10.0 for all-cause death, 16.7 and 3.6 for cardiovascular death, 23.1 and 5.2 for myocardial infarction, and 12.1 and 5.4 for stroke. Event rates in diabetic subjects with and those without proteinuria were, respectively, 39.9 and 6.3 for all-cause death and 18.7 and 1.2 for cardiovascular death. Nine of 11 relevant trials achieved primary end-point event rates clearly lower than predicted. trials including diabetic subjects without cardiovascular disease or proteinuria generate few events and require substantial participant numbers to achieve adequate power. However, the presence of coexisting cardiovascular disease or proteinuria increases event rates multiple-fold. Such data should aid investigators designing diabetes end-point trials.

  3. Role of imaging techniques in the evaluation of cardiovascular drugs

    International Nuclear Information System (INIS)

    Sugishita, Yasuro; Matsuda, Mitsuo; Ajisaka, Ryuichi

    1985-01-01

    In order to investigate the role of imaging in the evaluation of medical treatment in heart diseases, radionuclide angiocardiography, echocardiography and Doppler echocardiography were applied in the cases of various kinds of heart diseases. Acute and chronic effects of antianginal drugs (nitrates, calcium antagonists and beta-blockers) could be evaluated by exercise radionuclide angiocardiography or exercise echocardiography in the cases of effort angina. The effects of the drugs changing myocardial contractility, preload or afterload could be evaluated by echocardiography in various kinds of heart diseases, including valvular heart biseases. The effect of calcium antagonists in improving diastolic function in hypertrophic cardiomyopathy could be evaluated by echocardiography or Doppler echocardiography. In conclusion, imaging techniqus are valuable and useful methods to evaluate the effects of cardiovascular drugs, by offering various informations. (author)

  4. Sugars, obesity, and cardiovascular disease: results from recent randomized control trials.

    Science.gov (United States)

    Rippe, James M; Angelopoulos, Theodore J

    2016-11-01

    The relationship between sugar consumption and various health-related sequelas is controversial. Some investigators have argued that excessive sugar consumption is associated with increased risk of obesity, coronary heart disease, diabetes (T2D), metabolic syndrome, non-alcoholic fatty liver disease, and stimulation of reward pathways in the brain potentially causing excessive caloric consumption. These concerns have influenced organizations such as the World Health Organization, the Scientific Advisory Committee on Nutrition in England not to exceed 5 % of total energy and the Dietary Guidelines for Americans Advisory Committee 2015 to recommend upper limits of sugar consumption not to exceed 10 % of calories. Data from many randomized control trials (RCTs) do not support linkages between sugar consumption at normal levels within the human diet and various adverse metabolic and health-related effects. Fructose and glucose are typically consumed together in roughly equal proportions from high-fructose corn syrup (also known as isoglucose in Europe) or sucrose. The purpose of this review is to present data from recent RCTs and findings from recent systematic reviews and meta-analyses related to sugar consumption and its putative health effects. This review evaluates findings from recent randomized controlled trials, systematic reviews and meta-analyses into the relationship of sugar consumption and a range of health-related issues including energy-regulating hormones, obesity, cardiovascular disease, diabetes, and accumulation of liver fat and neurologic responses. Data from these sources do not support linkages between sugar consumption at normal levels within the human diet and various adverse metabolic and health-related effects.

  5. Carotid intimal-media thickness as a surrogate for cardiovascular disease events in trials of HMG-CoA reductase inhibitors

    Directory of Open Access Journals (Sweden)

    Morgan Timothy

    2005-03-01

    Full Text Available Abstract Background Surrogate measures for cardiovascular disease events have the potential to increase greatly the efficiency of clinical trials. A leading candidate for such a surrogate is the progression of intima-media thickness (IMT of the carotid artery; much experience has been gained with this endpoint in trials of HMG-CoA reductase inhibitors (statins. Methods and Results We examine two separate systems of criteria that have been proposed to define surrogate endpoints, based on clinical and statistical arguments. We use published results and a formal meta-analysis to evaluate whether progression of carotid IMT meets these criteria for HMG-CoA reductase inhibitors (statins. IMT meets clinical-based criteria to serve as a surrogate endpoint for cardiovascular events in statin trials, based on relative efficiency, linkage to endpoints, and congruency of effects. Results from a meta-analysis and post-trial follow-up from a single published study suggest that IMT meets established statistical criteria by accounting for intervention effects in regression models. Conclusion Carotid IMT progression meets accepted definitions of a surrogate for cardiovascular disease endpoints in statin trials. This does not, however, establish that it may serve universally as a surrogate marker in trials of other agents.

  6. The Impact of Web-Based Feedback on Physical Activity and Cardiovascular Health of Nurses Working in a Cardiovascular Setting: A Randomized Trial

    Directory of Open Access Journals (Sweden)

    Jennifer L. Reed

    2018-03-01

    Full Text Available A disconcerting proportion of Canadian nurses are physically inactive and report poor cardiovascular health. Web-based interventions incorporating feedback and group features may represent opportune, convenient, and cost-effective methods for encouraging physical activity (PA in order to improve the levels of PA and cardiovascular health of nurses. The purpose of this parallel-group randomized trial was to examine the impact of an intervention providing participants with feedback from an activity monitor coupled with a web-based individual, friend or team PA challenge, on the PA and cardiovascular health of nurses working in a cardiovascular setting.Methods: Nurses were randomly assigned in a 1:1:1 ratio to one of the following intervention “challenge” groups: (1 individual, (2 friend or (3 team. Nurses wore a Tractivity® activity monitor throughout a baseline week and 6-week intervention. Height, body mass, body fat percentage, waist circumference, resting blood pressure (BP and heart rate were assessed, and body mass index (BMI was calculated, during baseline and within 1 week post-intervention. Data were analyzed using descriptive statistics and general linear model procedures for repeated measures.Results: 76 nurses (97% female; age: 46 ± 11 years participated. Weekly moderate-to-vigorous intensity PA (MVPA changed over time (F = 4.022, df = 4.827, p = 0.002, η2 = 0.055, and was greater during intervention week 2 when compared to intervention week 6 (p = 0.011. Daily steps changed over time (F = 7.668, df = 3.910, p < 0.001, η2 = 0.100, and were greater during baseline and intervention weeks 1, 2, 3, and 5 when compared to intervention week 6 (p < 0.05. No differences in weekly MVPA or daily steps were observed between groups (p > 0.05. No changes in body mass, BMI or waist circumference were observed within or between groups (p > 0.05. Decreases in body fat percentage (−0.8 ± 4.8%, p = 0.015 and resting systolic BP (−2.6 ± 8

  7. Relevance of positive cardiovascular outcome trial results in clinical practice: perspectives from the Academy for Cardiovascular Risk, Outcomes and Safety Studies in Type 2 Diabetes (ACROSS T2D

    Directory of Open Access Journals (Sweden)

    Schernthaner G

    2017-12-01

    Full Text Available Guntram Schernthaner,1 Kamlesh Khunti,2 Chaim Lotan,3 Michel Burnier,4 Heinz Drexel,5 Martin Prázný61Department of Medicine I, Rudolfstiftung Hospital, Vienna, Austria; 2Diabetes Research Centre, Leicester General Hospital, Leicester, UK; 3Cardiovascular Division, Hadassah Medical Centre, Jerusalem, Israel; 4Division of Nephrology and Hypertension Consultation, University Hospital of Lausanne, Lausanne, Switzerland; 5Vorarlberg Institute for Vascular Investigation and Treatment, Feldkirch, Austria; 6Charles University, Prague, Czech RepublicAbstract: Type 2 diabetes (T2D imposes a substantial disease burden, predominantly from cardiovascular disease (CVD, which accounts for >50% of deaths in this population and leads to a 12-year reduction in the life expectancy of a 60-year-old male patient with T2D and CVD compared with the general population. The results from mandatory cardiovascular outcome trials (CVOTs are therefore of great interest in the field. The Academy for Cardiovascular Risk, Outcomes and Safety Studies in Type 2 Diabetes meeting program aims to bring together experts from several associated disciplines to provide fair and balanced resources for those involved in the management of patients with T2D. This publication represents the opinions of the faculty on the key learnings from the meeting held in Vienna in the spring of 2017. In particular, we detail how data from the EMPA-REG OUTCOME® [cardiovascular outcomes trial of empagliflozin] and Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER® (liraglutide CVOTs can be practically interpreted across clinical specialities. It is hoped that this translation of CVOT data will achieve a dual treatment paradigm for the management of both raised glucose levels and CV risk in patients with T2D. Keywords: type 2 diabetes, cardiovascular disease, CVOT, SGLT2 inhibitors, GLP-1 agonists, DPP-4 inhibitors

  8. The cardiac model of rehabilitation for reducing cardiovascular risk factors post transient ischaemic attack and stroke: a randomized controlled trial.

    Science.gov (United States)

    Kirk, Hayden; Kersten, Paula; Crawford, Pamela; Keens, Angela; Ashburn, Ann; Conway, Joy

    2014-04-01

    To evaluate the feasibility and effectiveness of a standard National Health Service cardiac rehabilitation programme on risk factor reduction for patients after a minor stroke and transient ischaemic attack. Single-blind randomized controlled trial. Cardiac rehabilitation classes. Twenty-four patients. All participants received standard care. In addition, the intervention group undertook an eight-week cardiac rehabilitation programme consisting of weekly exercise and education classes. Cardiovascular disease risk score; lipid profiles; resting blood pressure; C-reactive protein (measured with a high sensitive assay) and fibrinogen levels; blood glucose; obesity; physical activity levels; subjective health status (SF-36); Hospital Anxiety and Depression Scale. Group comparison with independent t-tests showed a significantly greater improvement in the cardiovascular disease risk score for participants in the intervention group compared to standard care (intervention 25.7 ± 22.8 to 23.15 ± 18.3, control 25.03 ± 15.4 to 27.12 ± 16.1, t = -1.81, P rehabilitation programmes are a feasible and effective means of reducing the risk of future cardiovascular events for patients after minor stroke and transient ischaemic attack.

  9. The acute and sub-chronic effects of cocoa flavanols on mood, cognitive and cardiovascular health in young healthy adults: a randomized, controlled trial.

    Science.gov (United States)

    Massee, Laura A; Ried, Karin; Pase, Matthew; Travica, Nikolaj; Yoganathan, Jaesshanth; Scholey, Andrew; Macpherson, Helen; Kennedy, Greg; Sali, Avni; Pipingas, Andrew

    2015-01-01

    Cocoa supplementation has been associated with benefits to cardiovascular health. However, cocoa's effects on cognition are less clear. A randomized, placebo-controlled, double-blind clinical trial (n = 40, age M = 24.13 years, SD = 4.47 years) was conducted to investigate the effects of both acute (same-day) and sub-chronic (daily for four-weeks) 250 mg cocoa supplementation on mood and mental fatigue, cognitive performance and cardiovascular functioning in young, healthy adults. Assessment involved repeated 10-min cycles of the Cognitive Demand Battery (CDB) encompassing two serial subtraction tasks (Serial Threes and Sevens), a Rapid Visual Information Processing task, and a mental fatigue scale over the course of half an hour. The Swinburne University Computerized Cognitive Assessment Battery (SUCCAB) was also completed to evaluate cognition. Cardiovascular function included measuring both peripheral and central blood pressure and cerebral blood flow. At the acute time point, consumption of cocoa significantly improved self-reported mental fatigue and performance on the Serial Sevens task in cycle one of the CDB. No other significant effects were found. This trial was registered with the Australian and New Zealand Clinical Trial Registry (Trial ID: ACTRN12613000626763). Accessible via http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN12613000626763&ddlSearch=Registered.

  10. The acute and sub-chronic effects of cocoa flavanols on mood, cognitive and cardiovascular health in young healthy adults: A randomized, controlled trial

    Directory of Open Access Journals (Sweden)

    Laura Amy Massee

    2015-05-01

    Full Text Available Cocoa supplementation has been associated with benefits to cardiovascular health. However, cocoa’s effects on cognition are less clear. A randomized, placebo-controlled, double-blind clinical trial (n=40, age M= 24.13 years, SD = 4.47 years was conducted to investigate the effects of both acute (same-day and sub-chronic (daily for four-weeks 250mg cocoa supplementation on mood and mental fatigue, cognitive performance and cardiovascular functioning in young, healthy adults. Assessment involved repeated 10-minute cycles of the Cognitive Demand Battery (CDB encompassing two serial subtraction tasks (Serial Threes and Sevens, a Rapid Visual Information Processing task, and a mental fatigue scale over the course of half an hour. The Swinburne University Computerised Cognitive Assessment Battery (SUCCAB was also completed to evaluate cognition. Cardiovascular function included measuring both peripheral and central blood pressure and cerebral blood flow. At the acute time point, consumption of cocoa significantly improved self-reported mental fatigue and performance on the Serial Sevens task in cycle one of the CDB. No other significant effects were found. This trial was registered with the Australian and New Zealand Clinical Trial Registry (Trial ID: ACTRN12613000626763. Accessible via http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN126130006 26763&ddlSearch=Registered

  11. Basic fibroblast growth factor predicts cardiovascular disease occurrence in participants from the Veterans Affairs Diabetes Trial

    Directory of Open Access Journals (Sweden)

    Mark B Zimering

    2013-11-01

    Full Text Available Aim: Cardiovascular disease is a leading cause of morbidity and mortality in adults with type 2 diabetes mellitus. The aim of the present study was to test whether plasma basic fibroblast growth factor (bFGF levels predict future cardiovascular disease (CVD occurrence in adults from the Veterans Affairs Diabetes Trial. Methods: Nearly four- hundred veterans, 40 years of age or older, having a mean baseline diabetes duration of 11.4 years were recruited from outpatient clinics at six geographically distributed sites in the Veterans Affairs Diabetes Trial (VADT. Within the VADT, they were randomly assigned to intensive or standard glycemic treatment, with follow-up as much as seven and one-half years. Cardiovascular disease occurrence was examined at baseline in the patient population and during randomized treatment. Plasma bFGF was determined with a sensitive, specific two-site enzyme-linked immunoassay at the baseline study visit in all 399 subjects. Results: One hundred-five first cardiovascular events occurred in these 399 subjects. The best fit model of risk factors associated with the time to first cardiovascular disease occurrence (in the study over a seven and one-half year period had as significant predictors: prior cardiovascular event, (hazard ratio [HR] 3.378; 95% confidence intervals [CI] 3.079- 3.807; P < .0001, baseline plasma bFGF (HR 1.008; 95% CI 1.002-1.014; P =.01, age, (HR 1.027; 95% CI 1.004-1.051; P =.019, baseline plasma triglycerides, (HR 1.001; 95% CI 1.000-1.002; P =.02 and diabetes duration-treatment interaction (P =.03. Intensive glucose-lowering was associated with significantly decreased hazard ratios for CVD occurrence (0.38-0.63 in patients with known diabetes duration of 0-10 years, and non-significantly increased hazard ratios for CVD occurrence (0.82-1.78 in patients with longer diabetes duration. Conclusion: High level ofplasma basic fibroblast growth factor is a predictive biomarker of future cardiovascular

  12. Plasma lipidomic profiles and cardiovascular events in a randomized intervention trial with the Mediterranean diet.

    Science.gov (United States)

    Toledo, Estefanía; Wang, Dong D; Ruiz-Canela, Miguel; Clish, Clary B; Razquin, Cristina; Zheng, Yan; Guasch-Ferré, Marta; Hruby, Adela; Corella, Dolores; Gómez-Gracia, Enrique; Fiol, Miquel; Estruch, Ramón; Ros, Emilio; Lapetra, José; Fito, Montserrat; Aros, Fernando; Serra-Majem, Luis; Liang, Liming; Salas-Salvadó, Jordi; Hu, Frank B; Martínez-González, Miguel A

    2017-10-01

    Background: Lipid metabolites may partially explain the inverse association between the Mediterranean diet (MedDiet) and cardiovascular disease (CVD). Objective: We evaluated the associations between 1 ) lipid species and the risk of CVD (myocardial infarction, stroke, or cardiovascular death); 2 ) a MedDiet intervention [supplemented with extra virgin olive oil (EVOO) or nuts] and 1-y changes in these molecules; and 3 ) 1-y changes in lipid species and subsequent CVD. Design: With the use of a case-cohort design, we profiled 202 lipid species at baseline and after 1 y of intervention in the PREDIMED (PREvención con DIeta MEDiterránea) trial in 983 participants [230 cases and a random subcohort of 790 participants (37 overlapping cases)]. Results: Baseline concentrations of cholesterol esters (CEs) were inversely associated with CVD. A shorter chain length and higher saturation of some lipids were directly associated with CVD. After adjusting for multiple testing, direct associations remained significant for 20 lipids, and inverse associations remained significant for 6 lipids. When lipid species were weighted by the number of carbon atoms and double bonds, the strongest inverse association was found for CEs [HR: 0.39 (95% CI: 0.22, 0.68)] between extreme quintiles ( P -trend = 0.002). Participants in the MedDiet + EVOO and MedDiet + nut groups experienced significant ( P < 0.05) 1-y changes in 20 and 17 lipids, respectively, compared with the control group. Of these changes, only those in CE(20:3) in the MedDiet + nuts group remained significant after correcting for multiple testing. None of the 1-y changes was significantly associated with CVD risk after correcting for multiple comparisons. Conclusions: Although the MedDiet interventions induced some significant 1-y changes in the lipidome, they were not significantly associated with subsequent CVD risk. Lipid metabolites with a longer acyl chain and higher number of double bonds at baseline were significantly

  13. Emergency Medical Services Data for Cardiovascular Disease Surveillance, Program Planning, and Evaluation in Maine

    OpenAIRE

    Meyer, Katie A; Decker, Kathy; Mervis, Cynthia A; Louder, Danielle; Bradshaw, Jay; DeVader, Shannon; Wigand, Debra

    2008-01-01

    Rapid access to medical treatment is a key determinant of outcomes for cardiovascular events. Emergency medical services (EMS) play an important role in delivering early treatment for acute cardiovascular events. Attention has increased on the potential for EMS data to contribute to our understanding of prehospital treatment. Maine recently began to explore the possible role of EMS data in cardiovascular disease surveillance and cardiovascular health program planning and evaluation. We descri...

  14. Lung Deflation and Cardiovascular Structure and Function in Chronic Obstructive Pulmonary Disease. A Randomized Controlled Trial.

    Science.gov (United States)

    Stone, Ian S; Barnes, Neil C; James, Wai-Yee; Midwinter, Dawn; Boubertakh, Redha; Follows, Richard; John, Leonette; Petersen, Steffen E

    2016-04-01

    Patients with chronic obstructive pulmonary disease develop increased cardiovascular morbidity with structural alterations. To investigate through a double-blind, placebo-controlled, crossover study the effect of lung deflation on cardiovascular structure and function using cardiac magnetic resonance. Forty-five hyperinflated patients with chronic obstructive pulmonary disease were randomized (1:1) to 7 (maximum 14) days inhaled corticosteroid/long-acting β2-agonist fluticasone furoate/vilanterol 100/25 μg or placebo (7-day minimum washout). Primary outcome was change from baseline in right ventricular end-diastolic volume index versus placebo. There was a 5.8 ml/m(2) (95% confidence interval, 2.74-8.91; P deflation on intrinsic myocardial function. Clinical trial registered with www.clinicaltrials.gov (NCT 01691885).

  15. Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS)--a randomized placebo-controlled trial.

    Science.gov (United States)

    Neal, Bruce; Perkovic, Vlado; de Zeeuw, Dick; Mahaffey, Kenneth W; Fulcher, Greg; Stein, Peter; Desai, Mehul; Shaw, Wayne; Jiang, Joel; Vercruysse, Frank; Meininger, Gary; Matthews, David

    2013-08-01

    Sodium glucose co-transporter 2 inhibition is a novel mode of treatment for type 2 diabetes mellitus (T2DM). The sodium glucose co-transporter 2 inhibitor canagliflozin lowered blood glucose, blood pressure, and body weight, with increased risk of urogenital infections in Phase 2 studies. Effects on macrovascular complications of diabetes remain to be determined. CANVAS is a double-blind, placebo-controlled trial designed to evaluate the effects of canagliflozin on the risk of cardiovascular disease and to assess safety and tolerability in patients with inadequately controlled T2DM and increased cardiovascular risk. The first of 2 planned phases randomized 4,330 individuals to placebo, canagliflozin 100 or 300 mg (1:1:1) with planned follow-up of about 2 years to substantiate potential cardiovascular protection by assessing key biomarkers and to achieve initial safety objectives. By the end of mid-September 2012, a total of 7174 patient-years of follow-up were accrued. Mean baseline age was 62 years, duration of diabetes 13 years; hemoglobin A1c 8.2%, fasting plasma glucose 9.3 mmol/L, and body mass index 32 kg/m(2). Of the participants, 34% are female and 57% had a history of atherosclerotic vascular disease. Participants will be followed up to achieve primary safety and tolerability objectives and to investigate secondary outcomes. The planned second phase will not be undertaken. CANVAS will define the effects of canagliflozin on biomarkers and provide data on cardiovascular safety against established regulatory parameters. Copyright © 2013 Mosby, Inc. All rights reserved.

  16. Improved delivery of cardiovascular care (IDOCC through outreach facilitation: study protocol and implementation details of a cluster randomized controlled trial in primary care

    Directory of Open Access Journals (Sweden)

    Akbari Ayub

    2011-09-01

    project implementation. Discussion This pragmatic, stepped-wedge randomized controlled trial with both quantitative and process evaluations demonstrates innovative methods of implementing large-scale quality improvement and evidence-based approaches to care delivery. This is the first Canadian study to examine the impact of a large-scale multifaceted cardiovascular quality-improvement program in primary care. It is anticipated that through the evaluation of IDOCC, we will demonstrate an effective, practical, and sustainable means of improving the cardiovascular health of patients across Canada. Trial Registration ClinicalTrials.gov: NCT00574808

  17. Race, medical researcher distrust, perceived harm, and willingness to participate in cardiovascular prevention trials.

    Science.gov (United States)

    Braunstein, Joel B; Sherber, Noëlle S; Schulman, Steven P; Ding, Eric L; Powe, Neil R

    2008-01-01

    Minority underrepresentation exists in medical research including cardiovascular clinical trials, but the hypothesis that this relates to distrust in medical researchers is unproven. Therefore, we examined whether African American persons differ from white persons in perceptions of the risks/benefits of trial participation and distrust toward medical researchers, and whether these factors influence willingness to participate (WTP) in a clinical drug trial. Participants were self-administered a survey regarding WTP in a cardiovascular drug trial given to 1440 randomly selected patients from 13 Maryland outpatient cardiology and general medicine clinics. Patients reported their WTP, rated their perceived chances of experiencing health benefit and harm, and rated their distrust toward researchers. Of eligible participants, 70% responded, and 717 individuals were included: 36% African American and 64% white. African American participants possessed lower WTP than white participants (27% vs. 39%, p = 0.001) and had higher mean distrust scores than whites (p prescribe medication as a way of experimenting on people without their knowledge (35% vs. 16%, p < 0.001), and ask them to participate in research even if it could harm them (24% vs. 15%, p = 0.002). African American participants also more often believed they could less freely ask their doctor questions (8% vs. 2%, p < 0.001) and that doctors had previously experimented on them without their consent (58% vs. 25%, p < 0.001). African American participants expressed lesser WTP than white participants after controlling for racial differences in age, sex, socioeconomic status and cardiovascular disease risk profiles (multivariable odds ratio [OR], 0.57; 95% confidence interval [CI], 0.39-0.85). The impact of race was attenuated and nonsignificant after adjustment for potential mediating factors of racial differences in medical researcher distrust and perceived risk of harm (explanatory model OR, 0.84; 95% CI 0

  18. Effectiveness of personalized face-to-face and telephone nursing counseling interventions for cardiovascular risk factors: a controlled clinical trial.

    Science.gov (United States)

    Vílchez Barboza, Vivian; Klijn, Tatiana Paravic; Salazar Molina, Alide; Sáez Carrillo, Katia Lorena

    2016-08-08

    to evaluate the effect and gender differences of an innovative intervention involving in-person and telephone nursing counseling to control cardiovascular risk factors (arterial hypertension, dyslipidemia, and overweight), improve health-related quality of life and strengthen self-efficacy and social support in persons using the municipal health centers' cardiovascular health program. a randomized controlled clinical trial involving participants randomized into the intervention group who received traditional consultation plus personalized and telephone nursing counseling for 7 months (n = 53) and the control group (n = 56). The study followed the Consolidated Standards of Reporting Trials Statement. women in the intervention group presented a significant increase in the physical and mental health components compared to the control group, with decreases in weight, abdominal circumference, total cholesterol, low-density lipoprotein cholesterol, and the atherogenic index. The effects attributable to the intervention in the men in the intervention group were increased physical and emotional roles and decreased systolic and diastolic pressure, waist circumference, total cholesterol, low-density lipoprotein cholesterol, atherogenic index, cardiovascular risk factor, and 10-year coronary risk. this intervention is an effective strategy for the control of three cardiovascular risk factors and the improvement of health-related quality of life. evaluar efecto y diferencias por sexo de una intervención innovadora "Consejería de Enfermería Personalizada y Telefónica", dirigida al control de factores de riesgo cardiovascular (hipertensión arterial, dislipidemia y sobrepeso) y al mejoramiento de la calidad de vida relacionada con la salud, fortaleciendo la autoeficacia y el apoyo social en personas usuarias del programa de salud cardiovascular de los Centros de Salud Municipales de Concepción. ensayo clínico controlado aleatoriamente y selección aleatoria de

  19. Serial Measurement of High-Sensitivity Troponin I and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus in the EXAMINE Trial (Examination of Cardiovascular Outcomes With Alogliptin Versus Standard of Care).

    Science.gov (United States)

    Cavender, Matthew A; White, William B; Jarolim, Petr; Bakris, George L; Cushman, William C; Kupfer, Stuart; Gao, Qi; Mehta, Cyrus R; Zannad, Faiez; Cannon, Christopher P; Morrow, David A

    2017-05-16

    We aimed to describe the relationship between changes in high-sensitivity cardiac troponin I (hsTnI) and cardiovascular outcomes. The EXAMINE trial (Examination of Cardiovascular Outcomes With Alogliptin Versus Standard of Care) was a phase IIIb clinical outcomes trial designed to evaluate the cardiovascular safety of alogliptin, a nonselective dipeptidyl peptidase 4 inhibitor. Patients with type 2 diabetes mellitus, glycohemoglobin between 6.5% and 11% (or between 7% and 11% if they were on insulin), and a recent acute coronary syndrome (between 15 and 90 days before randomization) were eligible for the trial. hsTnI was measured using the Abbott ARCHITECT assay at baseline and 6 months in patients randomized in the EXAMINE trial. This analysis was restricted to patients randomized ≥30 days after qualifying acute coronary syndrome to mitigate the potential for persistent hsTnI elevation after acute coronary syndrome (n=3808). The primary end point of the trial was cardiovascular death, myocardial infarction, or stroke. Cardiovascular death or heart failure was a prespecified, adjudicated secondary end point. At baseline, hsTnI was detectable (≥1.9 ng/L) in 93% of patients and >99 th percentile upper reference limit in 16%. There was a strong relationship between increasing hsTnI, both at baseline and 6 months, and the incidence of cardiovascular events through 24 months ( P 28.1% versus 8.8%; adjusted hazard ratio, 2.65; 95% confidence interval, 1.64-4.28; P 22.5% versus 8.8%; adjusted hazard ratio, 1.90; 95% confidence interval, 1.33-2.70; P 22.3% versus 23.0%; hazard ratio, 0.87; 95% confidence interval, 0.60-1.25; P =0.44). Serial assessment of hsTnI revealed a substantial proportion of patients with type 2 diabetes mellitus without clinically recognized events had dynamic or persistently elevated values and were at high risk of recurrent events. hsTnI may have a role in personalizing preventive strategies in patients with diabetes mellitus based on risk

  20. Statins but not aspirin reduce thrombotic risk assessed by thrombin generation in diabetic patients without cardiovascular events: the RATIONAL trial.

    Directory of Open Access Journals (Sweden)

    Alejandro Macchia

    Full Text Available The systematic use of aspirin and statins in patients with diabetes and no previous cardiovascular events is controversial. We sought to assess the effects of aspirin and statins on the thrombotic risk assessed by thrombin generation (TG among patients with type II diabetes mellitus and no previous cardiovascular events.Prospective, randomized, open, blinded to events evaluation, controlled, 2×2 factorial clinical trial including 30 patients randomly allocated to aspirin 100 mg/d, atorvastatin 40 mg/d, both or none. Outcome measurements included changes in TG levels after treatment (8 to 10 weeks, assessed by a calibrated automated thrombogram. At baseline all groups had similar clinical and biochemical profiles, including TG levels. There was no interaction between aspirin and atorvastatin. Atorvastatin significantly reduced TG measured as peak TG with saline (85.09±55.34 nmol vs 153.26±75.55 nmol for atorvastatin and control groups, respectively; p = 0.018. On the other hand, aspirin had no effect on TG (121.51±81.83 nmol vs 116.85±67.66 nmol, for aspirin and control groups, respectively; p = 0.716. The effects of treatments on measurements of TG using other agonists were consistent.While waiting for data from ongoing large clinical randomized trials to definitively outline the role of aspirin in primary prevention, our study shows that among diabetic patients without previous vascular events, statins but not aspirin reduce thrombotic risk assessed by TG.ClinicalTrials.gov NCT00793754.

  1. Differential cardiovascular profiles of sodium-glucose cotransporter 2 inhibitors: critical evaluation of empagliflozin

    Directory of Open Access Journals (Sweden)

    Sanon VP

    2017-05-01

    Full Text Available Vani P Sanon,1 Shalin Patel,1 Saurabh Sanon,2 Ruben Rodriguez,1 Son V Pham,1 Robert Chilton1 1Division of Cardiology, University of Texas Health Science Center at San Antonio, Audie L Murphy VA Hospital, San Antonio, TX, 2Interventional Cardiology-Structural Heart Disease, Cardiology Consultants at Baptist Heart and Vascular Institute, Pensacola, FL, USA Abstract: One of the most feared repercussions of type 2 diabetes mellitus is the risk of adverse cardiovascular outcomes. The current antidiabetic agents on the market have had difficulty in showing cardiovascular outcome improvement. The EMPA-REG OUTCOME trial studied the sodium-glucose cotransporter 2 inhibitor empagliflozin in type 2 diabetic patients at high risk of cardiovascular events. The trial results revealed a decrease in the composite primary end points of death from cardiovascular causes, nonfatal myocardial infarction, and nonfatal stroke in those taking empagliflozin vs placebo. Those taking the medication also had a significant decrease in death from any cause, death from cardiovascular cause, and hospitalization for heart failure. The EMPA-REG trial is paradigm shifting because it demonstrates a clear mortality benefit to cardiovascular outcomes with a low side-effect profile, in contrast to prior outcome studies of hypoglycemic agents. Further studies are required to better clarify the long-term safety and efficacy of this promising class of diabetic drugs. Keywords: SGLT2 inhibitors, diabetes, cardiovascular mortality, heart failure, hypertension

  2. Mixed methods evaluation of targeted case finding for cardiovascular disease prevention using a stepped wedged cluster RCT

    Directory of Open Access Journals (Sweden)

    Marshall Tom

    2012-10-01

    Full Text Available Abstract Background A pilot project cardiovascular prevention was implemented in Sandwell (West Midlands, UK. This used electronic primary care records to identify untreated patients at high risk of cardiovascular disease then invited these high risk patients for assessment by a nurse in their own general practice. Those found to be eligible for treatment were offered treatment. During the pilot a higher proportion of high risk patients were started on treatment in the intervention practices than in control practices. Following the apparent success of the prevention project, it was intended to extend the service to all practices across the Sandwell area. However the pilot project was not a robust evaluation. There was a need for an efficient evaluation that would not disrupt the planned rollout of the project. Methods/design Project nurses will sequentially implement targeted cardiovascular case finding in a phased way across all general practices, with the sequence of general practices determined randomly. This is a stepped wedge randomised controlled trial design. The target population is patients aged 35 to 74, without diabetes or cardiovascular disease whose ten-year cardiovascular risk, (determined from data in their electronic records is ≥20%. The primary outcome is the number of high risk patients started on treatment, because these data could be efficiently obtained from electronic primary care records. From this we can determine the effects of the case finding programme on the proportion of high risk patients started on treatment in practices before and after implementation of targeted case finding. Cost-effectiveness will be modelled from the predicted effects of treatments on cardiovascular events and associated health service costs. Alongside the implementation it is intended to interview clinical staff and patients who participated in the programme in order to determine acceptability to patients and clinicians. Practical

  3. Regression Discontinuity Design: Simulation and Application in Two Cardiovascular Trials with Continuous Outcomes

    NARCIS (Netherlands)

    van Leeuwen, Nikki; Lingsma, Hester F.; de Craen, Anton J. M.; Nieboer, Daan; Mooijaart, Simon P.; Richard, Edo; Steyerberg, Ewout W.

    2016-01-01

    In epidemiology, the regression discontinuity design has received increasing attention recently and might be an alternative to randomized controlled trials (RCTs) to evaluate treatment effects. In regression discontinuity, treatment is assigned above a certain threshold of an assignment variable for

  4. [Evaluation of cardiovascular risk in HIV positive patients in a specialized center at Santiago, Chile].

    Science.gov (United States)

    Lazcano, Camila; Millacura, Juan C; Saavedra, Felipe; Cortés, Claudia P

    2016-06-01

    Antiretroviral therapy has changed the course of HIV epidemic, as consequence, the patients present the same medical conditions than the rest ofthe population, including cardiovascular diseases. To describe the evolution of cardiovascular risk of HIV positive patients attending to a HIV/AIDS integral clinical center. Clinical charts were reviewed, looking for cardiovascular risk markers. Our findings showed a deficient evaluation of the cardiovascular basal risks at first medical control and patients had important metabolic alterations despite hypolipidemic treatment. Given the higher cardiovascular risk of this population, increasing the effort on diagnosis and treatment of HIV patients is required.

  5. Criteria for Evaluation of Novel Markers of Cardiovascular Risk

    Science.gov (United States)

    Hlatky, Mark A.; Greenland, Philip; Arnett, Donna K.; Ballantyne, Christie M.; Criqui, Michael H.; Elkind, Mitchell S.V.; Go, Alan S.; Harrell, Frank E.; Hong, Yuling; Howard, Barbara V.; Howard, Virginia J.; Hsue, Priscilla Y.; Kramer, Christopher M.; McConnell, Joseph P.; Normand, Sharon-Lise T.; O’Donnell, Christopher J.; Smith, Sidney C.; Wilson, Peter W.F.

    2010-01-01

    There is increasing interest in utilizing novel markers of cardiovascular disease risk, and consequently, there is a need to assess the value of their use. This scientific statement reviews current concepts of risk evaluation and proposes standards for the critical appraisal of risk assessment methods. An adequate evaluation of a novel risk marker requires a sound research design, a representative at-risk population, and an adequate number of outcome events. Studies of a novel marker should report the degree to which it adds to the prognostic information provided by standard risk markers. No single statistical measure provides all the information needed to assess a novel marker, so measures of both discrimination and accuracy should be reported. The clinical value of a marker should be assessed by its effect on patient management and outcomes. In general, a novel risk marker should be evaluated in several phases, including initial proof of concept, prospective validation in independent populations, documentation of incremental information when added to standard risk markers, assessment of effects on patient management and outcomes, and ultimately, cost-effectiveness. PMID:19364974

  6. Outcome reporting across randomised controlled trials evaluating therapeutic interventions for pre-eclampsia.

    Science.gov (United States)

    Duffy, Jmn; Hirsch, M; Kawsar, A; Gale, C; Pealing, L; Plana, M N; Showell, M; Williamson, P R; Khan, K S; Ziebland, S; McManus, R J

    2017-11-01

    Standardising outcome collection and reporting in pre-eclampsia trials requires an appraisal of current outcome reporting. To map maternal and offspring outcome reporting across randomised trials evaluating therapeutic interventions for pre-eclampsia. Randomised trials were identified by searching bibliographical databases from inception to January 2016. Randomised controlled trials. We systematically extracted and categorised outcome reporting. Seventy-nine randomised trials, reporting data from 31 615 maternal participants and 28 172 of their offspring, were included. Fifty-five different interventions were evaluated. Included trials reported 119 different outcomes, including 72 maternal outcomes and 47 offspring outcomes. Maternal outcomes were inconsistently reported across included trials; for example, 11 trials (14%) reported maternal mortality, reporting data from 12 422 participants, and 16 trials (20%) reported cardiovascular morbidity, reporting data from 14 963 maternal participants. Forty-three trials (54%) reported fetal outcomes and 23 trials (29%) reported neonatal outcomes. Twenty-eight trials (35%) reported offspring mortality. There was poor reporting of childhood outcomes: six trials (8%) reported neurodevelopmental outcomes. Less than half of included trials reported any relevant information regarding harms for maternal participants and their offspring. Most randomised trials evaluating interventions for pre-eclampsia are missing information on clinically important outcomes, and in particular have neglected to evaluate efficacy and safety in the offspring of participants. Developing and implementing a minimum data set, known as a core outcome set, in future pre-eclampsia trials could help to address these issues. Future #preeclampsia research requires a core outcome set to reduce #research waste. @coreoutcomes @jamesmnduffy International Prospective Register of Systematic Reviews: CRD42015015529; www.crd

  7. The effectiveness of integrative medicine interventions on pain and anxiety in cardiovascular inpatients: a practice-based research evaluation.

    Science.gov (United States)

    Johnson, Jill R; Crespin, Daniel J; Griffin, Kristen H; Finch, Michael D; Rivard, Rachael L; Baechler, Courtney J; Dusek, Jeffery A

    2014-12-13

    Pain and anxiety occurring from cardiovascular disease are associated with long-term health risks. Integrative medicine (IM) therapies reduce pain and anxiety in small samples of hospitalized cardiovascular patients within randomized controlled trials; however, practice-based effectiveness research has been limited. The goal of the study is to evaluate the effectiveness of IM interventions (i.e., bodywork, mind-body and energy therapies, and traditional Chinese medicine) on pain and anxiety measures across a cardiovascular population. Retrospective data obtained from medical records identified patients with a cardiovascular ICD-9 code admitted to a large Midwestern hospital between 7/1/2009 and 12/31/2012. Outcomes were changes in patient-reported pain and anxiety, rated before and after IM treatments based on a numeric scale (0-10). Of 57,295 hospital cardiovascular admissions, 6,589 (11.5%) included IM. After receiving IM therapy, patients averaged a 46.5% (p-value anxiety. There was no difference between treatment modalities on pain reduction; however, mind-body and energy therapies (p-value anxiety than bodywork therapies. Each additional year of age reduced the odds of receiving any IM therapy by two percent (OR: 0.98, p-value anxiety following care with adjunctive IM interventions. This study underscores the potential for future practice-based research to investigate the best approach for incorporating these therapies into an acute care setting such that IM therapies are most appropriately provided to patient populations.

  8. Baseline plasma fatty acids profile and incident cardiovascular events in the SU.FOL.OM3 trial: the evidence revisited.

    Directory of Open Access Journals (Sweden)

    Léopold K Fezeu

    Full Text Available OBJECTIVE: We aimed to investigate the association between baseline plasma fatty acids profile and the risk of future major cardiovascular events in patients with a history of ischaemic heart disease or ischemic stroke. METHODS: Baseline plasma fatty acids as well as established cardiovascular risk factors were measured in 2,263 patients enrolled in the SUpplementation with FOLate, vitamins B-6 and B-12 and/or OMega-3 fatty acids randomized controlled trial. Incident major cardiovascular, cardiac and cerebrovascular events were ascertained during the 4.7 years of follow up. Hazard ratios were obtained from Cox proportional hazards models after adjustment for cardiovascular risk factors. RESULTS: During the follow-up, 154, 379 and 84 patients had major cardiovascular, cardiac and cerebrovascular events respectively. Upon adjustment for gender, initial event, baseline age and BMI, the risk of developing a major cardiovascular event decreased significantly in successive quartiles of arachidonic acid (P trend<0.002, total omega 3 polyunsaturated fatty acids (P trend<0.03, docosapentaenoic acid (P trend<0.019, docosahexaenoic acid (P trend<0.004, eicosapentaenoic acid + docosahexaenoic acid (P trend<0.03 and eicosapentaenoic acid + docosapentaenoic acid + docosahexaenoic acid (P trend<0.02. This inverse association was borderline significant with increased quartiles of stearidonic acid (P trend<0.06. In the full model, only stearidonic acid remained inversely associated with the risk of developing a major cardiovascular event (P trend<0.035, a cardiac event (P trend<0.016 or a cerebrovascular event (P trend<0.014, while arachidonic acid was inversely associated with the risk a cerebrovascular event (P trend<0.033. CONCLUSION: The inverse association of long chain omega 3 polyunsaturated fatty acids with recurrence of Cardiovascular diseases was mainly driven by well-known cardiovascular risk factors. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN

  9. Improving clinical trials for cardiovascular diseases: a position paper from the Cardiovascular Round Table of the European Society of Cardiology

    NARCIS (Netherlands)

    Jackson, Neville; Atar, Dan; Borentain, Maria; Breithardt, Günter; van Eickels, Martin; Endres, Matthias; Fraass, Uwe; Friede, Tim; Hannachi, Hakima; Janmohamed, Salim; Kreuzer, Jörg; Landray, Martin; Lautsch, Dominik; Le Floch, Chantal; Mol, Peter; Naci, Huseyin; Samani, Nilesh J.; Svensson, Anders; Thorstensen, Cathrine; Tijssen, Jan; Vandzhura, Victoria; Zalewski, Andrew; Kirchhof, Paulus

    2016-01-01

    Cardiovascular disease is the most common cause of mortality and morbidity in the world, but the pharmaceutical industry's willingness to invest in this field has declined because of the many challenges involved with bringing new cardiovascular drugs to market, including late-stage failures,

  10. Improving clinical trials for cardiovascular diseases : a position paper from the Cardiovascular Round Table of the European Society of Cardiology

    NARCIS (Netherlands)

    Jackson, Neville; Atar, Dan; Borentain, Maria; Breithardt, Guenter; van Eickels, Martin; Endres, Matthias; Fraass, Uwe; Friede, Tim; Hannachi, Hakima; Janmohamed, Salim; Kreuzer, Joerg; Landray, Martin; Lautsch, Dominik; Le Floch, Chantal; Mol, Peter; Naci, Huseyin; Samani, Nilesh J.; Svensson, Anders; Thorstensen, Cathrine; Tijssen, Jan; Vandzhura, Victoria; Zalewski, Andrew; Kirchhof, Paulus

    2016-01-01

    Aims Cardiovascular disease is the most common cause of mortality and morbidity in the world, but the pharmaceutical industry's willingness to invest in this field has declined because of the many challenges involved with bringing new cardiovascular drugs to market, including late-stage failures,

  11. Developments in statistical evaluation of clinical trials

    CERN Document Server

    Oud, Johan; Ghidey, Wendimagegn

    2014-01-01

    This book describes various ways of approaching and interpreting the data produced by clinical trial studies, with a special emphasis on the essential role that biostatistics plays in clinical trials. Over the past few decades the role of statistics in the evaluation and interpretation of clinical data has become of paramount importance. As a result the standards of clinical study design, conduct and interpretation have undergone substantial improvement. The book includes 18 carefully reviewed chapters on recent developments in clinical trials and their statistical evaluation, with each chapter providing one or more examples involving typical data sets, enabling readers to apply the proposed procedures. The chapters employ a uniform style to enhance comparability between the approaches.

  12. Biased and inadequate citation of prior research in reports of cardiovascular trials is a continuing source of waste in research.

    Science.gov (United States)

    Sawin, Veronica I; Robinson, Karen A

    2016-01-01

    We assessed citation of prior research over time and the association of citation with the agreement of results between the trial being reported and the prior trial. Groups of pharmacologic trials in cardiovascular disease were created using meta-analyses, and we assessed citation within these groups. We calculated the proportion of prior trials cited, the proportion of study participants captured in citations, and agreement of results between citing and cited trials. Analysis included 86 meta-analyses with 580 trials published between 1982 and 2011. Reports of trials cited 25% (median; 95% confidence interval [CI], 23-27%) of prior trials, capturing 31% (95% CI, 25-36%) of trial participants. Neither measure differed by publication of the citing trial before vs. after 2005. Prior trials with results that agreed with the reports of trials (supportive trials) were significantly more likely to be cited than nonsupportive trials (relative risk 1.45; 95% CI, 1.30-1.61, P < 0.001). Selective undercitation of prior research continues; three quarters of existing evidence is ignored. This source of waste may result in unnecessary, unethical, and unscientific studies. Copyright © 2016 Elsevier Inc. All rights reserved.

  13. The PreCardio-study protocol – a randomized clinical trial of a multidisciplinary electronic cardiovascular prevention programme

    Directory of Open Access Journals (Sweden)

    Jacobs Nele

    2007-09-01

    Full Text Available Abstract Background Cardiovascular diseases (CVD are the leading cause of death and the third cause of disability in Europe. Prevention programmes should include interventions aimed at a reduction of medical risk factors (hypertension, hypercholesterol, hyperglycemia, overweight and obesity as well as behavioural risk factors (sedentary lifestyle, high fat intake and low fruit and vegetable intake, smoking. The aim of this study is to investigate the effects of a multifaceted, multidisciplinary electronic prevention programme on cardiovascular risk factors. Methods/Design In a randomized controlled trial, one group will receive a maximal intervention (= intervention group. The intervention group will be compared to the control group receiving a minimal intervention. An inclusion of 350 patients in total, with a follow-up of 3 years is foreseen. The inclusion criteria are age between 25–65 and insured by the Onderlinge Ziekenkas, insuring for guaranteed income in case of illness for self-employed. The maximal intervention group receives several prevention consultations by their general practitioner (GP using a new type of cardiovascular risk calculator with personalised feedback on behavioural risk factors. These patients receive a follow-up with intensive support of health behaviour change via different methods, i.e. a tailored website and personal advice of a multidisciplinary team (psychologist, physiotherapist and dietician. The aim of this strategy is to reduce cardiovascular risk factors according to the guidelines. The primary outcome measures will be cardiovascular risk factors. The secondary outcome measures are cardiovascular events, quality of life, costs and incremental cost effectiveness ratios. The control group receives prevention consultations using a new type of cardiovascular risk calculator and general feedback. Discussion This trial incorporates interventions by GPs and other health professionals aiming at a reduction of

  14. Is a reduction in albuminuria associated with renal and cardiovascular protection? A post hoc analysis of the ALTITUDE trial.

    Science.gov (United States)

    Heerspink, H J L; Ninomiya, T; Persson, F; Brenner, B M; Brunel, P; Chaturvedi, N; Desai, A S; Haffner, S M; Mcmurray, J J V; Solomon, S D; Pfeffer, M A; Parving, H-H; de Zeeuw, D

    2016-02-01

    To investigate whether the degree of albuminuria reduction observed in the ALTITUDE trial is associated with renal and cardiovascular protection, and secondly, whether the reduction in albuminuria was too small to afford clinical benefit. In a post hoc analysis of the ALTITUDE trial in 8561 patients with type 2 diabetes and chronic kidney disease or cardiovascular disease we examined the effect of albuminuria changes at 6 months on renal and cardiovascular outcomes using Cox proportional hazard regression. The median change in albuminuria in the first 6 months in the aliskiren arm of the trial was -12% (25th to 75th percentile: -48.7_to_ +41.9%) and 0.0% (25th to 75th percentile: -40.2_to_55%) in the placebo arm. Changes in albuminuria in the first 6 months were linearly associated with renal and cardiovascular endpoints: a >30% reduction in albuminuria in the first 6 months was associated with a 62% reduction in renal risk and a 25% reduction in cardiovascular risk compared with an increase in albuminuria. The association between changes at 6 months in albuminuria and renal or cardiovascular endpoints was similar in the two treatment groups (p for interaction >0.1 for both endpoints). The addition of aliskiren to angiotensin-converting enzyme inhibitor/angiotensin receptor blocker therapy resulted in albuminuria changes that were associated with renal and cardiovascular risk changes. This did not translate into renal or cardiovascular protection because the overall reduction in albuminuria in the aliskiren arm was too small and nearly similar to that in the placebo arm. © 2015 John Wiley & Sons Ltd.

  15. Randomized clinical trial studying effects of a personalized supervised lifestyle intervention program on cardiovascular status in physically inactive healthy volunteers.

    Science.gov (United States)

    Westergren, Helena U; Gan, Li-Ming; Månsson, Marianne; Svedlund, Sara

    2018-02-06

    The impact of personalized exercise training and a healthy dietary lifestyle in healthy volunteers on coronary flow reserve and cardiovascular function remains to be investigated in a controlled study setting. To examine the effects of a Mediterranean-inspired diet combined with regular physical exercise (standard) and a personalized supervised exercise program (DAPS) on coronary flow reserve and cardiovascular function. The number of males were 10 (59%) and 9 (47%) and mean age was 54 ± 12 and 55 ± 5 years in standard versus DAPS group, respectively. Primary outcomes were in addition to improved body composition and aerobic capacity, increased TDE-CFR (5.0%, CI:1.62,8.64, p = 0.005) and left ventricle ejection fraction (LVEF) during hyperemia (10.2%, CI:1.62,19.4, p = 0.022) in DAPS adjusted for the control period. Also, plasma fibrinogen decreased (-12.1%, CI:-22.0,-0.92, p = 0.035) in the DAPS group. Secondary outcomes, after adjusting DAPS intervention effects for the standard-training period, TDE-CFR and hyperemic LVEF remained significantly improved. This randomized, controlled clinical trial (URL: http://www.clinicaltrials.gov NCT02713724) included 36 healthy volunteers who underwent exercise ECG before randomization to standard or DAPS groups. Standard-group was given gym-membership with limited instructions and general dietary advice. DAPS-group received personalized supervised exercise programs and more detailed dietary advice with regular contact with a personal trainer. Effects were evaluated after 3 months. All participants underwent coronary flow reserve by transthoracic ultrasound (TDE-CFR), blood marker analysis and examinations of vascular function. Standard-group was evaluated pre-control, post-control (=pre-intervention) and post-intervention. DAPS-group was examined at pre-intervention and post-intervention. A personalized supervised training- and diet program improves cardiovascular status in healthy subjects with a physically inactive

  16. A double-blind, randomised, placebo-controlled trial of Ganoderma lucidum for the treatment of cardiovascular risk factors of metabolic syndrome

    Science.gov (United States)

    Klupp, Nerida L.; Kiat, Hosen; Bensoussan, Alan; Steiner, Genevieve Z.; Chang, Dennis H.

    2016-01-01

    This study aimed to evaluate the efficacy and safety of Ganoderma lucidum for the treatment of hyperglycaemia and other cardiovascular risk components of metabolic syndrome using a prospective, double-blind, randomised, placebo-controlled trial. Eighty-four participants with type 2 diabetes mellitus and metabolic syndrome were randomised to one of three intervention groups: Ganoderma lucidum, Ganoderma lucidum with Cordyceps sinensis, or placebo. The dosage was 3 g/day of Ganoderma lucidum, with or without Cordyceps sinensis, for 16 weeks. The primary outcome measure was blood glucose (glycosylated haemoglobin [HbA1c] and fasting plasma glucose [FPG]); a number of secondary outcome measures were also tested. Data from the two intervention groups were combined. The combined intervention had no effect on any of the primary (baseline-adjusted difference in means: HbA1c = 0.13%, 95% CI [−0.35, 0.60], p = 0.60; FPG = 0.03 mmol/L, 95% CI [−0.90, 0.96], p = 0.95) or secondary outcome measures over the course of the 16-week trial, and no overall increased risk of adverse events with either active treatment. Evidence from this randomised clinical trial does not support the use of Ganoderma lucidum for treatment of cardiovascular risk factors in people with diabetes mellitus or metabolic syndrome. This Clinical Trial was registered with the Australian New Zealand Clinical Trials Registry on November 23, 2006. Trial ID: ACTRN12606000485538 and can be accessed here: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=81705. PMID:27511742

  17. A double-blind, randomised, placebo-controlled trial of Ganoderma lucidum for the treatment of cardiovascular risk factors of metabolic syndrome.

    Science.gov (United States)

    Klupp, Nerida L; Kiat, Hosen; Bensoussan, Alan; Steiner, Genevieve Z; Chang, Dennis H

    2016-08-11

    This study aimed to evaluate the efficacy and safety of Ganoderma lucidum for the treatment of hyperglycaemia and other cardiovascular risk components of metabolic syndrome using a prospective, double-blind, randomised, placebo-controlled trial. Eighty-four participants with type 2 diabetes mellitus and metabolic syndrome were randomised to one of three intervention groups: Ganoderma lucidum, Ganoderma lucidum with Cordyceps sinensis, or placebo. The dosage was 3 g/day of Ganoderma lucidum, with or without Cordyceps sinensis, for 16 weeks. The primary outcome measure was blood glucose (glycosylated haemoglobin [HbA1c] and fasting plasma glucose [FPG]); a number of secondary outcome measures were also tested. Data from the two intervention groups were combined. The combined intervention had no effect on any of the primary (baseline-adjusted difference in means: HbA1c = 0.13%, 95% CI [-0.35, 0.60], p = 0.60; FPG = 0.03 mmol/L, 95% CI [-0.90, 0.96], p = 0.95) or secondary outcome measures over the course of the 16-week trial, and no overall increased risk of adverse events with either active treatment. Evidence from this randomised clinical trial does not support the use of Ganoderma lucidum for treatment of cardiovascular risk factors in people with diabetes mellitus or metabolic syndrome. This Clinical Trial was registered with the Australian New Zealand Clinical Trials Registry on November 23, 2006. Trial ID: ACTRN12606000485538 and can be accessed here: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=81705.

  18. Providing cardiovascular risk management information to acute coronary syndrome patients: a randomized trial.

    Science.gov (United States)

    Broadbent, Elizabeth; Leggat, Alexandra; McLachlan, Andy; Kerr, Andrew

    2013-02-01

    Cardiac patients have been shown to have inaccurate understanding of their cardiovascular risk. The purpose of the study was to investigate whether a guideline-based risk assessment and management intervention could facilitate understanding of cadiovascular risk and appropriate illness perceptions in cardiac patients. Randomized trial. A total of 106 patients with MI or unstable angina were randomized to receive standard care with or without a 30-min nurse-led computerized Predict CVD-Diabetes (where CVD is cardiovascular disease) session. Patients' risk perceptions (using categorical and numerical measures), and perceptions of their heart condition were assessed at admission, discharge, and 3 months. The intervention group rated the risk information as more easily understood than the control group. At discharge, they had increased perceptions of personal control, higher perceptions that a low-fat diet and regular exercise could help their condition, and believed their current illness would be shorter compared to the control group. At 3 months, no group differences were significant. The intervention had no effect on risk perceptions, which were high in both groups. Patients' perceptions of 'high' risk corresponded to numerical estimates of over 50%, which differs from clinical guidelines (over 20%). A computerized cardiovascular risk assessment and management session can help acute coronary syndrome patients understand CVD risk information and improve perceptions of control in the short term, but not change risk perceptions. In-hospital risk factor assessment and management information may help patients understand the importance of key lifestyle changes. WHAT IS ALREADY KNOWN ON THIS SUBJECT?: • Many members of the public, as well as patients with diagnosed coronary heart disease (CHD), have poor understanding of their cardiovascular disease risk. • Giving risk information can improve accuracy of risk perceptions, and may increase intentions to start preventive

  19. WP6 - Application Integration, Trials and Evaluation

    DEFF Research Database (Denmark)

    Prasad, Neeli R.; Cetin, Bilge Kartal; Moran, Humberto

    2009-01-01

    This deliverable contains all the details on the planning, description of business cases, business goals stakeholders, IT infrastructure, evaluation guidelines and other aspects of the pilot trials, that are envisioned for demonstrating the benefits of the ASPIRE middleware platform. These pilot...... middleware platform during their trials. The pilots aim to cover different business sectors, scenarios and applications related to RFID (Radio Frequency Identification) systems, thus giving a diverse set of outcomes that will be able to provide a better perspective on how ASPIRE will help in the reduction...... of the Total cost of ownership (TCO) associated to RFID systems as well as to confirm the ease of implementation of ASPIRE open source software (OSS) components into current IT SME infrastructure.The different pilot trials described in this deliverable are the following: • A Logistics pilot for the packing...

  20. Evaluation of Total Cardiovascular Risk in Patients with Hypertension and Impaired Glucose Tolerance

    Directory of Open Access Journals (Sweden)

    I.V. Cherniavska

    2016-11-01

    Full Text Available Aim. Timely reveal of the patients at high risk of cardiovascular diseases for whom earlier intervention for cardiovascular risk correction is the most effective. Materials and methods. Seventy patients aged 30–55 years old with stage 2 hypertension, impaired glucose tolerance (IGT and high cardiovascular risk were examined according to Framingham criteria. Cardiovascular risk was compared by SCORE and PROCAM results. Results. Percentage ratio of males with high cardiovascular risk was higher by 52.3 % in comparison to females by SCORE and by 2.3 % in comparison to females by PROCAM. Males did not present any significant discrepancy by evaluation of cardiovascular risk by both scores unlike females. Obtained results showed that total cardiovascular risk in females was twofold higher by PROCAM compared to SCORE scale. Conclusions. Total cardiovascular risk level in patients with stage 2 hypertension and IGT is influenced by age, systolic blood pressure level, smoking, lipid storage disease and carbohydrate metabolism disorder. When we evaluate total cardiovascular risk, we should not be limited only by determination of factors determined in SCORE. It is reasonable to evaluate risk factors by PROCAM, too, especially for females.

  1. Effects of alcohol and polyphenols from beer on atherosclerotic biomarkers in high cardiovascular risk men: a randomized feeding trial.

    Science.gov (United States)

    Chiva-Blanch, G; Magraner, E; Condines, X; Valderas-Martínez, P; Roth, I; Arranz, S; Casas, R; Navarro, M; Hervas, A; Sisó, A; Martínez-Huélamo, M; Vallverdú-Queralt, A; Quifer-Rada, P; Lamuela-Raventos, R M; Estruch, R

    2015-01-01

    Moderate alcohol consumption exerts a cardioprotective effect, but no studies have evaluated the alcohol-independent cardiovascular effects of the non-alcoholic components of beer. We aimed to evaluate the effects of ethanol and the phenolic compounds of beer on classical and novel cardiovascular risk factors. Thirty-three high risk male volunteers were included in a randomized, crossover feeding trial. After a washout period, all subjects received beer (30 g alcohol/d, 660 mL), the equivalent amount of polyphenols as non-alcoholic beer (990 mL), and gin (30 g alcohol/d, 100 mL) for 4 weeks. All outcomes were evaluated before and after each intervention period. Moderate alcohol consumption increased serum HDL-cholesterol (∼5%), ApoA-I (∼6%), ApoA-II (∼7%) and adiponectin (∼7%), and decreased serum fibrinogen (∼8%), and interleukin (IL)-5 (∼14%) concentrations, whereas the non-alcoholic fraction of beer (mainly polyphenols) increased the receptor antagonist of IL-1 (∼24%), and decreased lymphocyte expression of lymphocyte function-associated antigen-1 (∼11%), lymphocyte and monocyte expression of Sialil-Lewis X (∼16%) and monocyte expression of CCR2 (∼31%), and tumor necrosis factor (TNF)-β (∼14%) and IL-15 (∼22%) plasma concentrations. No changes were observed in glucose metabolism parameters or in body weight and adiposity parameters. The phenolic content of beer reduces leukocyte adhesion molecules and inflammatory biomarkers, whereas alcohol mainly improves the lipid profile and reduces some plasma inflammatory biomarkers related to atherosclerosis. Copyright © 2014 Elsevier B.V. All rights reserved.

  2. Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), cardiovascular outcomes: randomised controlled trial.

    NARCIS (Netherlands)

    Farkouh, M.E.; Kirshner, H.; Harrington, R.A.; Ruland, S.; Verheugt, F.W.A.; Schnitzer, T.J.; Burmester, G.R.; Mysler, E.; Hochberg, M.C.; Doherty, M.; Ehrsam, E.; Gitton, X.; Krammer, G.; Mellein, B.; Gimona, A.; Matchaba, P.; Hawkey, C.J.; Chesebro, J.H.

    2004-01-01

    BACKGROUND: The potential for cyclo-oxygenase 2 (COX2)-selective inhibitors to increase the risk for myocardial infarction is controversial. The Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET) aimed to assess gastrointestinal and cardiovascular safety of the COX2 inhibitor

  3. [Meta-analysis of clinical trials of folic acid, vitamin B12 and B6 supplementation on plasma homocysteine level and risk of cardiovascular disease].

    Science.gov (United States)

    Li, Jun; Li, Bin; Qi, Juanfei; Shen, Bo

    2015-06-01

    To evaluate the effects of folic acid, vitamin B(6) and B(12) supplementation on plasma homocysteine level and risk of cardiovascular disease. The databases, including Embase, Pubmed, Ovid, Biosis, China National Knowledge Infra-structure (CNKI), Wanfang Data, VIP Database for Chinese Technical Periodical (VIP), Chinese Biomedical Literature Database (CMB), were searched to identify random control trials between February 1994 to February 2014 on the effect of folic acid, vitamin B(6) and B(12) supplementation on plasma homocysteine level and risk of cardiovascular disease. The screening, data extraction and quality assessment were conducted in accordance with the inclusion and exclusion criteria by two reviewers independently. The software Review Manager 5.2 was used. Funnel plots and Egger's regression test were applied to evaluate the publication bias. Data from 12 studies including 34 481 patients were analyzed using a fixed-effects model. Funnel plot and Egger's test (P > 0.10) confirmed the absence of publication bias. No statistically significant heterogeneity was detected on testing after excluding the sources of heterogeneity (chi-square test, I folic acid, vitamin B(6) and B(12) groups (all P > 0.05). Mean homocysteine levels were significantly lower with folic acid, vitamin B(6) and B(12) therapy compared with placebo during follow-up (all P folic acid, vitamin B(6) and B(12) supplementation compared with placebo were 0.98 (0.93-1.03) for cardiovascular event, 0.97 (0.87-1.07) for coronary artery disease, 1.00 (0.92-1.08) for myocardial infarction and 0.92 (0.82-1.03) for cardiovascular death. Folic aicd combined with vitamin B(6) and B(12) treatment significantly reduced plasma homocysteine level, but did not affect the risk of cardiovascular disease. Thus, folic acid combined with vitamin B(6) and B(12) should not be recommended as secondary prevention of cardiovascular diseases.

  4. Development and evaluation of a patient centered cardiovascular health education program for insured patients in rural Nigeria (QUICK - II

    Directory of Open Access Journals (Sweden)

    Osibogun Akin

    2011-03-01

    Full Text Available Abstract Background In Sub Saharan Africa, the incidence of hypertension and other modifiable cardiovascular risk factors is growing rapidly. Poor adherence to prescribed prevention and treatment regimens by patients can compromise treatment outcomes. Patient-centered cardiovascular health education is likely to improve shortcomings in adherence. This paper describes a study that aims to develop a cardiovascular health education program for patients participating in a subsidized insurance plan in Nigeria and to evaluate the applicability and effectiveness in patients at increased risk for cardiovascular disease. Methods/Design Design: The study has two parts. Part 1 will develop a cardiovascular health education program, using qualitative interviews with stakeholders. Part 2 will evaluate the effectiveness of the program in patients, using a prospective (pre-post observational design. Setting: A rural primary health center in Kwara State, Nigeria. Population: For part 1: 40 patients, 10 healthcare professionals, and 5 insurance managers. For part 2: 150 patients with uncontrolled hypertension or other cardiovascular risk factors after one year of treatment. Intervention: Part 2: patient-centered cardiovascular health education program. Measurements: Part 1: Semi-structured interviews to identify stakeholder perspectives. Part 2: Pre- and post-intervention assessments including patients' demographic and socioeconomic data, blood pressure, body mass index and self-reporting measures on medication adherence and perception of care. Feasibility of the intervention will be measured using process data. Outcomes: For program development (part 1: overview of healthcare professionals' perceptions on barriers and facilitators to care, protocol for patient education, and protocol implementation plan. For program evaluation (part 2: changes in patients' scores on adherence to medication and life style changes, blood pressure, and other physiological and self

  5. Circulating N-Linked Glycoprotein Side-Chain Biomarker, Rosuvastatin Therapy, and Incident Cardiovascular Disease: An Analysis From the JUPITER Trial.

    Science.gov (United States)

    Akinkuolie, Akintunde O; Glynn, Robert J; Padmanabhan, Latha; Ridker, Paul M; Mora, Samia

    2016-07-13

    GlycA, a novel protein glycan biomarker of N-acetyl side chains of acute-phase proteins, was recently associated with incident cardiovascular disease (CVD) in healthy women. Whether GlycA predicts CVD events in the setting of statin therapy in men and women without CVD but with evidence of chronic inflammation is unknown. In the Justfication for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) trial (NCT00239681), participants with low-density lipoprotein cholesterol 0.20). In the JUPITER trial, increased levels of GlycA were associated with an increased risk of CVD events independent of traditional risk factors and hsCRP. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00239681. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

  6. Cardiovascular rehabilitation soon after stroke using feedback-controlled robotics-assisted treadmill exercise: study protocol of a randomised controlled pilot trial.

    Science.gov (United States)

    Stoller, Oliver; de Bruin, Eling D; Schuster-Amft, Corina; Schindelholz, Matthias; de Bie, Rob A; Hunt, Kenneth J

    2013-09-22

    -assisted treadmill exercise is a relatively recent intervention method and might be used to train and evaluate aerobic capacity in this population. The present pilot trial is expected to provide new insights into the implementation of early cardiovascular exercise for individuals with severe motor impairment. The findings of this study may guide future research to explore the effects of early cardiovascular activation after severe neurological events. This trial is registered with the Clinical Trials.gov Registry (NCT01679600).

  7. Feasibility, Process, and Outcomes of Cardiovascular Clinical Trial Data Sharing: A Reproduction Analysis of the SMART-AF Trial.

    Science.gov (United States)

    Gay, Hawkins C; Baldridge, Abigail S; Huffman, Mark D

    2017-12-01

    Data sharing is as an expanding initiative for enhancing trust in the clinical research enterprise. To evaluate the feasibility, process, and outcomes of a reproduction analysis of the THERMOCOOL SMARTTOUCH Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (SMART-AF) trial using shared clinical trial data. A reproduction analysis of the SMART-AF trial was performed using the data sets, data dictionary, case report file, and statistical analysis plan from the original trial accessed through the Yale Open Data Access Project using the SAS Clinical Trials Data Transparency platform. SMART-AF was a multicenter, single-arm trial evaluating the effectiveness and safety of an irrigated, contact force-sensing catheter for ablation of drug refractory, symptomatic paroxysmal atrial fibrillation in 172 participants recruited from 21 sites between June 2011 and December 2011. Analysis of the data was conducted between December 2016 and April 2017. Effectiveness outcomes included freedom from atrial arrhythmias after ablation and proportion of participants without any arrhythmia recurrence over the 12 months of follow-up after a 3-month blanking period. Safety outcomes included major adverse device- or procedure-related events. The SMART AF trial participants' mean age was 58.7 (10.8) years, and 72% were men. The time from initial proposal submission to final analysis was 11 months. Freedom from atrial arrhythmias at 12 months postprocedure was similar compared with the primary study report (74.0%; 95% CI, 66.0-82.0 vs 76.4%; 95% CI, 68.7-84.1). The reproduction analysis success rate was higher than the primary study report (65.8%; 95% CI 56.5-74.2 vs 75.6%; 95% CI, 67.2-82.5). Adverse events were minimal and similar between the 2 analyses, but contact force range or regression models could not be reproduced. The feasibility of a reproduction analysis of the SMART-AF trial was demonstrated through an academic data-sharing platform. Data sharing can be

  8. Patients' and providers' perspectives of a polypill strategy to improve cardiovascular prevention in Australian primary health care: a qualitative study set within a pragmatic randomized, controlled trial.

    Science.gov (United States)

    Liu, Hueiming; Massi, Luciana; Laba, Tracey-Lea; Peiris, David; Usherwood, Tim; Patel, Anushka; Cass, Alan; Eades, Anne-Marie; Redfern, Julie; Hayman, Noel; Howard, Kirsten; Brien, Jo-anne; Jan, Stephen

    2015-05-01

    This study explores health provider and patient attitudes toward the use of a cardiovascular polypill as a health service strategy to improve cardiovascular prevention. In-depth, semistructured interviews (n=94) were conducted with health providers and patients from Australian general practice, Aboriginal community-controlled and government-run Indigenous Health Services participating in a pragmatic randomized controlled trial evaluating a polypill-based strategy for high-risk primary and secondary cardiovascular disease prevention. Interview topics included polypill strategy acceptability, factors affecting adherence, and trial implementation. Transcribed interview data were analyzed thematically and interpretively. Polypill patients commented frequently on cost-savings, ease, and convenience of a daily-dosing pill. Most providers considered a polypill strategy to facilitate improved patient medication use. Indigenous Health Services providers and indigenous patients thought the strategy acceptable and beneficial for indigenous patients given the high disease burden. Providers noted the inflexibility of the fixed dose regimen, with dosages sometimes inappropriate for patients with complex management considerations. Future polypill formulations with varied strengths and classes of medications may overcome this barrier. Many providers suggested the polypill strategy, in its current formulations, might be more suited to high-risk primary prevention patients. The polypill strategy was generally acceptable to patients and providers in cardiovascular prevention. Limitations to provider acceptability of this particular polypill were revealed, as was a perception it might be more suitable for high-risk primary prevention patients, though future combinations could facilitate its use in secondary prevention. Participants suggested a polypill-based strategy as particularly appropriate for lowering the high cardiovascular burden in indigenous populations. URL: http

  9. Observed and predicted reduction of ischemic cardiovascular events in the Simvastatin and Ezetimibe in Aortic Stenosis trial

    DEFF Research Database (Denmark)

    Holme, Ingar; Boman, Kurt; Brudi, Philippe

    2010-01-01

    In the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial, combined ezetimibe (10 mg) and simvastatin (40 mg) decreased low-density lipoprotein cholesterol levels by 50% and ischemic cardiovascular event (ICE) risk by 22% compared to placebo. A larger decrease in ICE risk might have been...... expected for the degree of lipid-lowering observed. This analysis investigated relations between changes in lipoprotein components (LCs), and ICE risk decrease in the SEAS trial in all patients, by severity of aortic stenosis (AS), and compared to results of other clinical trials. A total of 1,570 patients...

  10. International clinical trials, cardiovascular disease and treatment options in the Russian Federation: research and treatment in practice.

    Science.gov (United States)

    Zvonareva, Olga; Engel, Nora; Martsevich, Sergey; de Wert, Guido; Horstman, Klasien

    2015-03-01

    The issue of balance between research and treatment in clinical trials conduct has been surrounded by controversies. Scientific characteristics of trials may compromise medical care available to participants, while conceiving research participation as having therapeutic value may foster the therapeutic misconception. However, it has also been questioned whether research can and should always be separated from medical care provision. In this paper we analyze how these concerns played out in practice settings of the three trial sites in Russia, specialized in trials in cardiovascular diseases. Using in-depth interviews with participants of phase II and III trials (n = 21) and discussions with physician-investigators (n = 7), we found that trial enrollment allowed participants to establish continuous supportive relationships with the physician-investigators. In the context of unresponsive health care, chronically ill participants received regular monitoring, treatment recommendations and help in case of problems and emergencies through such relationships. The trial designs in the three sites did not preclude the provision of individualized treatment. We suggest that debates about the research/treatment interface in trials need to become more attuned to the conditions in locations of their conduct, views and experiences of actors involved and evolving trial methodologies. Too much focus on categorical differentiation of research and treatment may obscure the fact that globalizing clinical trials proceed amidst profound health disparities, dismiss diverse concerns of people on the ground and risk attenuating responsibilities of trial organizers, sponsors and investigators towards research participants. Copyright © 2015 Elsevier Ltd. All rights reserved.

  11. Kettlebell training for musculoskeletal and cardiovascular health: a randomized controlled trial.

    Science.gov (United States)

    Jay, Kenneth; Frisch, Dennis; Hansen, Klaus; Zebis, Mette K; Andersen, Christoffer H; Mortensen, Ole S; Andersen, Lars L

    2011-05-01

    The aim of this trial was to investigate the effectiveness of a worksite intervention using kettlebell training to improve musculoskeletal and cardiovascular health. This single-blind randomized controlled trial involved 40 adults from occupations with a high prevalence of reported musculoskeletal pain symptoms (mean age 44 years, body mass index 23 kg/m², 85% women, with pain intensity of the neck/shoulders 3.5 and of the low back 2.8 on a scale of 0-10). A blinded assessor took measures at baseline and follow-up. Participants were randomly assigned to training--consisting of ballistic full-body kettlebell exercise 3 times per week for 8 weeks--or a control group. The main outcome measures were pain intensity of the neck/shoulders and low back, isometric muscle strength, and aerobic fitness. Compared with the control group, pain intensity of the neck/shoulders decreased 2.1 points [95% confidence interval (95% CI) -3.7- -0.4] and pain intensity of the low back decreased 1.4 points (95% CI -2.7- -0.02) in the training group. Compared with the control group, the training group increased muscle strength of the trunk extensors (Pkettlebell training reduces pain in the neck/shoulders and low back and improves muscle strength of the low back among adults from occupations with a high prevalence of reported musculoskeletal pain symptoms. This type of training does not appear to improve aerobic fitness.

  12. Low-fat dietary pattern and cardiovascular disease: results from the Women's Health Initiative randomized controlled trial.

    Science.gov (United States)

    Prentice, Ross L; Aragaki, Aaron K; Van Horn, Linda; Thomson, Cynthia A; Beresford, Shirley Aa; Robinson, Jennifer; Snetselaar, Linda; Anderson, Garnet L; Manson, JoAnn E; Allison, Matthew A; Rossouw, Jacques E; Howard, Barbara V

    2017-07-01

    Background: The influence of a low-fat dietary pattern on the cardiovascular health of postmenopausal women continues to be of public health interest. Objective: This report evaluates low-fat dietary pattern influences on cardiovascular disease (CVD) incidence and mortality during the intervention and postintervention phases of the Women's Health Initiative Dietary Modification Trial. Design: Participants comprised 48,835 postmenopausal women aged 50-79 y; 40% were randomly assigned to a low-fat dietary pattern intervention (target of 20% of energy from fat), and 60% were randomly assigned to a usual diet comparison group. The 8.3-y intervention period ended in March 2005, after which >80% of surviving participants consented to additional active follow-up through September 2010; all participants were followed for mortality through 2013. Breast and colorectal cancer were the primary trial outcomes, and coronary heart disease (CHD) and overall CVD were additional designated outcomes. Results: Incidence rates for CHD and total CVD did not differ between the intervention and comparison groups in either the intervention or postintervention period. However, CHD HRs comparing these groups varied strongly with baseline CVD and hypertension status. Participants without prior CVD had an intervention period CHD HR of 0.70 (95% CI: 0.56, 0.87) or 1.04 (95% CI: 0.90, 1.19) if they were normotensive or hypertensive, respectively ( P -interaction = 0.003). The CHD benefit among healthy normotensive women was partially offset by an increase in ischemic stroke risk. Corresponding HRs in the postintervention period were close to null. Participants with CVD at baseline (3.4%) had CHD HRs of 1.47 (95% CI: 1.12, 1.93) and 1.61 (95% CI: 1.02, 2.55) in the intervention and postintervention periods, respectively. However, various lines of evidence suggest that results in women with CVD or hypertension at baseline are confounded by postrandomization use of cholesterol-lowering medications

  13. L-arginine supplementation and risk factors of cardiovascular diseases in healthy men: a double-blind randomized clinical trial.

    Science.gov (United States)

    Pahlavani, Naseh; Jafari, Mostafa; Sadeghi, Omid; Rezaei, Masoud; Rasad, Hamid; Rahdar, Hossein Ali; Entezari, Mohammad Hasan

    2014-01-01

    Context: The effect of L-arginine on risk factors of cardiovascular diseases (CVD) has mostly focused on western countries. Since cardiovascular diseases is the second cause of death in Iran and, as far as we are aware, there have been no studies about the effect of L-arginine on CVD risk factors, the aim of this trial was to assess the effects of L-arginine supplementation on CVD risk factors in healthy men. Objective:  The purpose of this study was to evaluate the effect of low-dose L-arginine supplementation on CVD risk factors (lipid profile, blood sugar and blood pressure) in Iranian healthy men. Design, setting, participants:  We conducted a double-blind randomized controlled trial in 56 patients selected from sport clubs at the Isfahan University of Medical Science between November 2013 and December 2013. Interventions: Healthy men received L-arginine supplementation (2000 mg daily) in the intervention group or placebo (2000 mg maltodextrin daily) in the control group for 45 days. Main outcome measure:  The primary outcome measures were we measured the levels of fasting blood sugar, blood pressure and lipid profile including triglyceride (TG), cholesterol, LDL and HDL in healthy subjects. It was hypothesized that these measures would be significantly improved in those receiving L-arginine supplementation. at the beginning and end of the study. Results:  In this trial, we had complete data for 52 healthy participants with mean age of 20.85±4.29 years. At the end of study, fasting blood sugar (P=0.001) and lipid profile (triglycerideTG (PL-arginine group but we found no significant change in the placebo group. In addition, the reduction of fasting blood sugar and lipid profile in L-arginine was significant compared with placebo group. No significant changes were found about systolic (P=0.81) and diastolic blood pressure either in L-arginine or placebo group. (P=0.532). Conclusion : The use of L-arginine significantly improved outcomes compared to placebo.

  14. L-arginine supplementation and risk factors of cardiovascular diseases in healthy men: a double-blind randomized clinical trial

    Science.gov (United States)

    Pahlavani, Naseh; Jafari, Mostafa; Sadeghi, Omid; Rezaei, Masoud; Rasad, Hamid; Rahdar, Hossein Ali; Entezari, Mohammad Hasan

    2017-01-01

    Context: The effect of L-arginine on risk factors of cardiovascular diseases (CVD) has mostly focused on western countries. Since cardiovascular diseases is the second cause of death in Iran and, as far as we are aware, there have been no studies about the effect of L-arginine on CVD risk factors, the aim of this trial was to assess the effects of L-arginine supplementation on CVD risk factors in healthy men. Objective: The purpose of this study was to evaluate the effect of low-dose L-arginine supplementation on CVD risk factors (lipid profile, blood sugar and blood pressure) in Iranian healthy men. Design, setting, participants: We conducted a double-blind randomized controlled trial in 56 patients selected from sport clubs at the Isfahan University of Medical Science between November 2013 and December 2013. Interventions: Healthy men received L-arginine supplementation (2000 mg daily) in the intervention group or placebo (2000 mg maltodextrin daily) in the control group for 45 days. Main outcome measure: The primary outcome measures were we measured the levels of fasting blood sugar, blood pressure and lipid profile including triglyceride (TG), cholesterol, LDL and HDL in healthy subjects. It was hypothesized that these measures would be significantly improved in those receiving L–arginine supplementation. at the beginning and end of the study. Results: In this trial, we had complete data for 52 healthy participants with mean age of 20.85±4.29 years. At the end of study, fasting blood sugar (P=0.001) and lipid profile (triglycerideTG (PL-arginine group but we found no significant change in the placebo group. In addition, the reduction of fasting blood sugar and lipid profile in L-arginine was significant compared with placebo group. No significant changes were found about systolic (P=0.81) and diastolic blood pressure either in L-arginine or placebo group. (P=0.532). Conclusion: The use of L-arginine significantly improved outcomes compared to placebo

  15. Rosiglitazone evaluated for cardiovascular outcomes--an interim analysis

    DEFF Research Database (Denmark)

    Home, Philip D; Pocock, Stuart J; Beck-Nielsen, Henning

    2007-01-01

    group). The primary end point was hospitalization or death from cardiovascular causes. RESULTS: Because the mean follow-up was only 3.75 years, our interim analysis had limited statistical power to detect treatment differences. A total of 217 patients in the rosiglitazone group and 202 patients...

  16. Evaluation of the efficacy of cardiovascular supplement in reducing ...

    African Journals Online (AJOL)

    Cardiovascular disease is one of the leading causes of mortality which equals an average of 1 death every 33 seconds as confirmed by statistics from United States National Centre for Health Statistics (NCHS). Sixty healthy subjects within the age range 40 to 75 years (mean, 54. 7+ 3.3), M: F ratio given as 1.4:1 were ...

  17. Evaluation of cardiovascular risk factors in patients with hypertension

    African Journals Online (AJOL)

    Background: Hypertension is a major health concern in developed and developing countries. Its prevalence is high in Nigeria and accounts for a great percentage of hospital visits and admissions. Hypertension is a chief risk factor for cardiovascular events. Independent risks factors, some of which are implicated in the ...

  18. Randomized cross-over trial of short-term water-only fasting: metabolic and cardiovascular consequences.

    Science.gov (United States)

    Horne, B D; Muhlestein, J B; Lappé, D L; May, H T; Carlquist, J F; Galenko, O; Brunisholz, K D; Anderson, J L

    2013-11-01

    Routine, periodic fasting is associated with a lower prevalence of coronary artery disease (CAD). Animal studies show that fasting may increase longevity and alter biological parameters related to longevity. We evaluated whether fasting initiates acute changes in biomarker expression in humans that may impact short- and long-term health. Apparently-healthy volunteers (N = 30) without a recent history of fasting were enrolled in a randomized cross-over trial. A one-day water-only fast was the intervention and changes in biomarkers were the study endpoints. Bonferroni correction required p ≤ 0.00167 for significance (p fasting intervention acutely increased human growth hormone (p = 1.1 × 10⁻⁴), hemoglobin (p = 4.8 × 10⁻⁷), red blood cell count (p = 2.5 × 10⁻⁶), hematocrit (p = 3.0 × 10⁻⁶), total cholesterol (p = 5.8 × 10⁻⁵), and high-density lipoprotein cholesterol (p = 0.0015), and decreased triglycerides (p = 1.3 × 10⁻⁴), bicarbonate (p = 3.9 × 10⁻⁴), and weight (p = 1.0 × 10⁻⁷), compared to a day of usual eating. For those randomized to fast the first day (n = 16), most factors including human growth hormone and cholesterol returned to baseline after the full 48 h, with the exception of weight (p = 2.5 × 10⁻⁴) and (suggestively significant) triglycerides (p = 0.028). Fasting induced acute changes in biomarkers of metabolic, cardiovascular, and general health. The long-term consequences of these short-term changes are unknown but repeated episodes of periodic short-term fasting should be evaluated as a preventive treatment with the potential to reduce metabolic disease risk. Clinical trial registration (ClinicalTrials.gov): NCT01059760 (Expression of Longevity Genes in Response to Extended Fasting [The Fasting and Expression of Longevity Genes during Food abstinence {FEELGOOD} Trial]). Copyright © 2012 Elsevier B.V. All rights reserved.

  19. Physical activity and cardiovascular risk factors in children: meta-analysis of randomized clinical trials.

    Science.gov (United States)

    Cesa, Claudia Ciceri; Sbruzzi, Graciele; Ribeiro, Rodrigo Antonini; Barbiero, Sandra Mari; de Oliveira Petkowicz, Rosemary; Eibel, Bruna; Machado, Natássia Bigolin; Marques, Renata das Virgens; Tortato, Gabriela; dos Santos, Tiago Jerônimo; Leiria, Carina; Schaan, Beatriz D'Agord; Pellanda, Lucia Campos

    2014-12-01

    To assess the effects of physical activity interventions in preventing cardiovascular risk factors in childhood through a systematic review and meta-analysis of randomized clinical trials (RCTs). A search of online databases (PubMed, EMBASE and Cochrane CENTRAL) was conducted from inception until June 2013. RCTs enrolling children 6-12years old conducted physical activity interventions longer than 6months, assessing their effect on body mass index (BMI), systolic (SBP) and diastolic blood pressure (DBP), total cholesterol (TC) and triglycerides (TG) were included. Data analysis was performed using a random-effects model. Of 23.091 articles retrieved, 11 RCTs (10.748 subjects) were included. Physical activity interventions were not associated with reductions of BMI [-0.03kg/m(2) (95%CI -0.16, 0.13) I(2) 0%]. However, there was an association between the interventions and reduction of SBP [-1.25mmHg (95%CI -2.47, -0.02) I(2) 0%], DBP [-1.34mmHg (95%CI -2.57, -0.11) I(2) 43%] and TG [-0.09mmol/L (95%CI -0.14, -0.04) I(2) 0%], and increase of TC [0.14mmol/L (95%CI 0.01, 0.27) I(2) 0%]. As physical activity intervention programs lasting longer than 6months are associated with reductions in blood pressure levels and triglycerides, they should be considered to be included in prevention programs for cardiovascular diseases in schoolchildren. Copyright © 2014 Elsevier Inc. All rights reserved.

  20. The Yale Fitness Intervention Trial in female cancer survivors: Cardiovascular and physiological outcomes.

    Science.gov (United States)

    Knobf, M Tish; Jeon, Sangchoon; Smith, Barbara; Harris, Lyndsay; Thompson, Siobhan; Stacy, Mitchel R; Insogna, Karl; Sinusas, Albert J

    Induced premature menopause and cardio-toxic therapy increase cardiovascular disease risk in female cancer survivors. To compare the effects of a 12 month aerobic-resistance fitness center intervention to home based physical activity on cardiovascular function and metabolic risk factors. Subjects (N = 154) who had completed primary and/or adjuvant chemotherapy (past 3 years) were randomized to a fitness center intervention or a home based group. The fitness center intervention was a structured thrice weekly aerobic (30 min brisk walking treadmill in target heart range) combined with resistance (30 min of lower body strength training) exercise program, supervised for the first 6 months. The home based group received national guidelines for 30 min moderate intensity exercise most days of the week. Fasting serum samples were collected at baseline, 6 and 12 months for insulin, glucose, lipids and hemoglobin A-1C. A graded exercise stress test was also performed at baseline and 6 months. The majority of subjects were white (85.7%), had breast cancer (83.1%) and the average age was 51.9 years. Subjects in the fitness center intervention had significantly improved time on treadmill (p = .039), improved heart rate recovery at 1 min (p = .028), greater MET minutes/week (p ≤ .0001), a trend for improved insulin resistance (p = .067) and stable insulin levels (p = .045) compared to the home based physical activity group. Exercise represents a potential cardiac risk reduction intervention for cancer survivors. CLINICAL TRIALS.GOV: NCT01102985. Copyright © 2017. Published by Elsevier Inc.

  1. Nordic walking versus walking without poles for rehabilitation with cardiovascular disease: Randomized controlled trial.

    Science.gov (United States)

    Girold, Sébastien; Rousseau, Jérome; Le Gal, Magalie; Coudeyre, Emmanuel; Le Henaff, Jacqueline

    2017-07-01

    With Nordic walking, or walking with poles, one can travel a greater distance and at a higher rate than with walking without poles, but whether the activity is beneficial for patients with cardiovascular disease is unknown. This randomized controlled trial was undertaken to determine whether Nordic walking was more effective than walking without poles on walk distance to support rehabilitation training for patients with acute coronary syndrome (ACS) and peripheral arterial occlusive disease (PAOD). Patients were recruited in a private specialized rehabilitation centre for cardiovascular diseases. The entire protocol, including patient recruitment, took place over 2 months, from September to October 2013. We divided patients into 2 groups: Nordic Walking Group (NWG, n=21) and Walking Group without poles (WG, n=21). All patients followed the same program over 4 weeks, except for the walk performed with or without poles. The main outcome was walk distance on the 6-min walk test. Secondary outcomes were maximum heart rate during exercise and walk distance and power output on a treadmill stress test. We included 42 patients (35 men; mean age 57.2±11 years and BMI 26.5±4.5kg/m 2 ). At the end of the training period, both groups showed improved walk distance on the 6-min walk test and treatment stress test as well as power on the treadmill stress test (Ptraining period, Nordic walking training appeared more efficient than training without poles for increasing walk distance on the 6-min walk test for patients with ACS and PAOD. Copyright © 2017. Published by Elsevier Masson SAS.

  2. A Cluster-Randomized Controlled Trial of a Simplified Multifaceted Management Program for Individuals at High Cardiovascular Risk (SimCard Trial) in Rural Tibet, China and Haryana, India

    Science.gov (United States)

    Tian, Maoyi; Ajay, Vamadevan S.; Dunzhu, Danzeng; Hameed, Safraj S.; Li, Xian; Liu, Zhong; Li, Cong; Chen, Hao; Cho, KaWing; Li, Ruilai; Zhao, Xingshan; Jindal, Devraj; Rawal, Ishita; Ali, Mohammed K.; Peterson, Eric D.; Ji, Jiachao; Amarchand, Ritvik; Krishnan, Anand; Tandon, Nikhil; Xu, Li-Qun; Wu, Yangfeng; Prabhakaran, Dorairaj; Yan, Lijing L.

    2015-01-01

    Background In rural areas in China and India, cardiovascular disease burden is high but economic and healthcare resources are limited. This study aims to develop and evaluate a simplified cardiovascular management program (SimCard) delivered by community health workers (CHWs) with the aid of a smartphone-based electronic decision support system. Methods and Results The SimCard study was a yearlong cluster-randomized controlled trial conducted in 47 villages (27 in China and 20 in India). 2,086 ‘high cardiovascular risk’ individuals (aged 40 years or older with self-reported history of coronary heart disease, stroke, diabetes, and/or measured systolic blood pressure ≥160 mmHg) were recruited. Participants in the intervention villages were managed by CHWs through an Android-powered “app” on a monthly basis focusing on two medication use and two lifestyle modifications. Compared with the control group, the intervention group had a 25.5% (P<0.001) higher net increase in the primary outcome of the proportion of patient-reported anti-hypertensive medication use pre-and-post intervention. There were also significant differences in certain secondary outcomes: aspirin use (net difference 17.1%, P<0.001) and systolic blood pressure (−2.7 mmHg, P=0.04). However, no significant changes were observed in the lifestyle factors. The intervention was culturally tailored and country-specific results revealed important differences between the regions. Conclusions The results indicate that the simplified cardiovascular management program improved quality of primary care and clinical outcomes in resource-poor settings in China and India. Larger trials in more places are needed to ascertain potential impacts on mortality and morbidity outcomes. Clinical Trial Registration Information clinicaltrials.gov. Identifier: NCT01503814. PMID:26187183

  3. Randomised clinical trial of an intensive intervention in the primary care setting of patients with high plasma fibrinogen in the primary prevention of cardiovascular disease

    Directory of Open Access Journals (Sweden)

    José Rodríguez Cristóbal Juan

    2012-03-01

    Full Text Available Abstract Background We have studied the possible effects of an intensive lifestyle change program on plasma fibrinogen levels, in patients with no cardiovascular disease, with elevated levels of fibrinogen, normal cholesterol levels, and a moderate estimated risk of coronary heart disease (CHD and we have also analysed whether the effect on fibrinogen is independent of the effect on lipids. Results This clinical trial was controlled, unblinded and randomized, with parallel groups, done in 13 Basic Health Areas (BHA in l'Hospitalet de Llobregat (Barcelona and Barcelona city. The study included 436 patients, aged between 35 and 75 years, with no cardiovascular disease, elevated levels of fibrinogen (> 300 mg/dl, cholesterol The evaluation of the baseline characteristics of the patients showed that both groups were homogenous. Obesity and hypertension were the most prevalent risk factors. After 24 months of the study, statistically significant changes were seen between the adjusted means of the two groups, for the following parameters: fibrinogen, plasma cholesterol, systolic and diastolic blood pressure and body mass index. Conclusion Intensive intervention to achieve lifestyle changes has shown to be effective in reducing some of the estimated CHD factors. However, the effect of intensive intervention on plasma fibrinogen levels did not correlate with the variations in cholesterol. Trial Registration ClinicalTrials.gov: NCT01089530

  4. Efficacy of n-3 polyunsaturated fatty acids and feasibility of optimizing preventive strategies in patients at high cardiovascular risk: rationale, design and baseline characteristics of the Rischio and Prevenzione study, a large randomised trial in general practice.

    Science.gov (United States)

    2010-05-28

    The optimization of preventive strategies in patients at high risk of cardiovascular events and the evaluation of bottlenecks and limitations of transferring current guidelines to the real world of clinical practice are important limiting steps to cardiovascular prevention. Treatment with n-3 polyunsaturated fatty acids improves prognosis after myocardial infarction, but evidence of this benefit is lacking in patients at high cardiovascular risk, but without a history of myocardial infarction. Patients were eligible if their general practitioner (GP) considered them at high cardiovascular risk because of a cardiovascular disease other than myocardial infarction, or multiple risk factors (at least four major risk factors in non-diabetic patients and one in diabetics).Patients were randomly allocated to treatment with n-3 polyunsaturated fatty acids (1 g daily) or placebo in a double-blind study and followed up for five years by their GPs to assess the efficacy of the treatment in preventing cardiovascular mortality (including sudden death) and hospitalization for cardiovascular reasons. The secondary, epidemiological, aim of the study is to assess whether it is feasible to adopt current guidelines in everyday clinical practice, with a view to optimizing all the available preventive strategies in people at high cardiovascular risk.A nation-wide network of 860 GPs admitted 12,513 patients to the study between February 2004 and March 2007. The mean age was 64 years and 62% were males. Diabetes mellitus plus one or more cardiovascular risk factors was the main inclusion criterion (47%). About 30% of patients were included because of a history of atherosclerotic cardiovascular disease, 21% for four or more risk factors, and less than 1% for other reasons. The Rischio and Prevenzione (R&P) project provides a feasible model to test the efficacy of n-3 polyunsaturated fatty acid therapy in patients at high cardiovascular risk with no history of myocardial infarction, and to

  5. Mediterranean Diet and Invasive Breast Cancer Risk Among Women at High Cardiovascular Risk in the PREDIMED Trial: A Randomized Clinical Trial.

    Science.gov (United States)

    Toledo, Estefanía; Salas-Salvadó, Jordi; Donat-Vargas, Carolina; Buil-Cosiales, Pilar; Estruch, Ramón; Ros, Emilio; Corella, Dolores; Fitó, Montserrat; Hu, Frank B; Arós, Fernando; Gómez-Gracia, Enrique; Romaguera, Dora; Ortega-Calvo, Manuel; Serra-Majem, Lluís; Pintó, Xavier; Schröder, Helmut; Basora, Josep; Sorlí, José Vicente; Bulló, Mònica; Serra-Mir, Merce; Martínez-González, Miguel A

    2015-11-01

    Breast cancer is the leading cause of female cancer burden, and its incidence has increased by more than 20% worldwide since 2008. Some observational studies have suggested that the Mediterranean diet may reduce the risk of breast cancer. To evaluate the effect of 2 interventions with Mediterranean diet vs the advice to follow a low-fat diet (control) on breast cancer incidence. The PREDIMED study is a 1:1:1 randomized, single-blind, controlled field trial conducted at primary health care centers in Spain. From 2003 to 2009, 4282 women aged 60 to 80 years and at high cardiovascular disease risk were recruited after invitation by their primary care physicians. Participants were randomly allocated to a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with mixed nuts, or a control diet (advice to reduce dietary fat). Breast cancer incidence was a prespecified secondary outcome of the trial for women without a prior history of breast cancer (n = 4152). After a median follow-up of 4.8 years, we identified 35 confirmed incident cases of breast cancer. Observed rates (per 1000 person-years) were 1.1 for the Mediterranean diet with extra-virgin olive oil group, 1.8 for the Mediterranean diet with nuts group, and 2.9 for the control group. The multivariable-adjusted hazard ratios vs the control group were 0.32 (95% CI, 0.13-0.79) for the Mediterranean diet with extra-virgin olive oil group and 0.59 (95% CI, 0.26-1.35) for the Mediterranean diet with nuts group. In analyses with yearly cumulative updated dietary exposures, the hazard ratio for each additional 5% of calories from extra-virgin olive oil was 0.72 (95% CI, 0.57-0.90). This is the first randomized trial finding an effect of a long-term dietary intervention on breast cancer incidence. Our results suggest a beneficial effect of a Mediterranean diet supplemented with extra-virgin olive oil in the primary prevention of breast cancer. These results come from a secondary

  6. Meta Salud Diabetes study protocol: a cluster-randomised trial to reduce cardiovascular risk among a diabetic population of Mexico.

    Science.gov (United States)

    Sabo, Samantha; Denman Champion, Catalina; Bell, Melanie L; Cornejo Vucovich, Elsa; Ingram, Maia; Valenica, Celina; Castro Vasquez, Maria Del Carmen; Gonzalez-Fagoaga, Eduardo; Geurnsey de Zapien, Jill; Rosales, Cecilia B

    2018-03-12

    Northern Mexico has among the highest rates of cardiovascular disease (CVD) and diabetes in the world. This research addresses core gaps in implementation science to develop, test and scale-up CVD risk-reduction interventions in diabetics through a national primary care health system. The Meta Salud Diabetes (MSD) research project is a parallel two-arm cluster-randomised clinical behavioural trial based in 22 (n=22) health centres in Sonora, Mexico. MSD aims to evaluate the effectiveness of the MSD intervention for the secondary prevention of CVD risk factors among a diabetic population (n=320) compared with the study control of usual care. The MSD intervention consists of 2-hour class sessions delivered over a 13-week period providing educational information to encourage sustainable behavioural change to prevent disease complications including the adoption of physical activity. MSD is delivered within the context of Mexico's national primary care health centre system by health professionals, including nurses, physicians and community health workers via existing social support groups for individuals diagnosed with chronic disease. Mixed models are used to estimate the effect of MSD by comparing cardiovascular risk, as measured by the Framingham Risk Score, between the trial arms. Secondary outcomes include hypertension, behavioural risk factors and psychosocial factors. This work is supported by the National Institutes of Health, National Heart Lung and Blood Institute (1R01HL125996-01) and approved by the University of Arizona Research Institutional Review Board (Protocol 1508040144) and the Research Bioethics Committee at the University of Sonora. The first Internal Review Board approval date was 31 August 2015 with five subsequent approved amendments. This article refers to protocol V.0.2, dated 30 January 2017. Results will be disseminated via peer-reviewed publication and presentation at international conferences and will be shared through meetings with health

  7. Rationale and Design of the Cardiovascular Inflammation Reduction Trial (CIRT): A Test of the Inflammatory Hypothesis of Atherothrombosis

    Science.gov (United States)

    Everett, Brendan M.; Pradhan, Aruna D.; Solomon, Daniel H.; Paynter, Nina; MacFadyen, Jean; Zaharris, Elaine; Gupta, Milan; Clearfield, Michael; Libby, Peter; Hasan, Ahmed AK; Glynn, Robert J.; Ridker, Paul M

    2013-01-01

    Background Inflammation plays a fundamental role in atherothrombosis. Yet, whether direct inhibition of inflammation will reduce the occurrence of adverse cardiovascular outcomes is not known. Design The Cardiovascular Inflammation Reduction Trial (CIRT; ClinicalTrials.gov NCT01594333) will randomly allocate 7,000 patients with prior myocardial infarction and either type 2 diabetes or the metabolic syndrome to low dose methotrexate (target dose 15 to 20 mg per week) or placebo over an average follow-up period of 3 to 5 years. Low-dose methotrexate is a commonly used anti-inflammatory regimen for the treatment of rheumatoid arthritis, lacks significant effects on lipid levels, blood pressure, or platelet function. Both observational and mechanistic studies suggest that low-dose methotrexate has clinically relevant anti-atherothrombotic effects. The CIRT primary endpoint is a composite of nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death. Secondary endpoints are all-cause mortality, coronary revascularization plus the primary endpoint, hospitalization for congestive heart failure plus the primary endpoint, all-cause mortality plus coronary revascularization plus congestive heart failure plus the primary endpoint, incident type 2 diabetes, and net clinical benefit or harm. CIRT will employ standardized central methodology designed to ensure consistent performance of all dose adjustments and safety interventions at each clinical site in a manner that protects the blinding to treatment but maintains safety for enrolled participants. Summary CIRT aims to test the inflammatory hypothesis of atherothrombosis in patients with prior myocardial infarction and either type 2 diabetes or metabolic syndrome, conditions associated with persistent inflammation. If low-dose methotrexate reduces cardiovascular events, CIRT would provide a novel therapeutic approach for the secondary prevention of heart attack, stroke, and cardiovascular death. (Clinical Trial

  8. Family-centered brief intervention for reducing obesity and cardiovascular disease risk: A randomized controlled trial.

    Science.gov (United States)

    Duncan, Scott; Goodyear-Smith, Felicity; McPhee, Julia; Zinn, Caryn; Grøntved, Anders; Schofield, Grant

    2016-11-01

    To assess the effects of a family-centered, physical activity and nutrition "brief" intervention (time-limited contact) on body weight and related health outcomes in primary health care patients with an elevated 5-year cardiovascular disease (CVD) risk. This study implemented a cluster randomized controlled trial design with two treatment conditions: a CVD risk assessment and one-time consultation ("usual care" control) and a CVD risk assessment and up to five home sessions that aimed to reduce obesity by encouraging physical activity and healthy eating (intervention). Three hundred and twenty patients aged 35 to 65 years from 16 primary health care clinics in Auckland, New Zealand, participated in the study. Intervention effects on BMI, waist circumference, blood pressure, blood cholesterol, triglycerides, 5-year CVD risk, physical activity, and dietary patterns were assessed using generalized linear mixed models. When compared with the control group, the intervention resulted in a significant but relatively modest decrease in BMI between baseline and the 12-month follow-up (-0.633 kg m -2 , P adj  = 0.048). Significant decreases were also observed for total cholesterol at 4 and 12 months, the total cholesterol to high-density lipoprotein cholesterol ratio at 4 months, 5-year CVD risk at 4 months, and fast food consumption at 12 months. Our findings show that a family-centered brief intervention targeting physical activity and nutrition can generate slightly better obesity-related health outcomes than usual care alone. © 2016 The Obesity Society.

  9. Prevalence of cardiovascular disease and evaluation of standard of care in type 2 diabetes

    DEFF Research Database (Denmark)

    Rungby, Jorgen; Schou, Morten; Warrer, Per

    2017-01-01

    Objective: Cardiovascular disease (CVD) complicates type 2 diabetes. Empagliflozin and liraglutide have demonstrated improved survival in patients with type 2 diabetes and established CVD. We assessed prevalence and standard of care of patients with type 2 diabetes and established CVD managed......-density lipoprotein cholesterol was 2.0 mmol/l. Conclusion: In a nationwide database survey in primary care, the prevalence of CVD in patients with type 2 diabetes was high (21.4%). Standard of care was largely in accordance with national guidelines. Identification of eligible patients is possible with existing...... electronic patient record systems. Identifying this high-risk subgroup of patients with type 2 diabetes and optimizing their treatment might add further cardiovascular benefits as suggested by recent cardiovascular outcome trials....

  10. Using Machine Learning Algorithms in Cardiovascular Disease Risk Evaluation

    Directory of Open Access Journals (Sweden)

    D. A. Sitar-Taut

    2009-01-01

    Full Text Available Even if Medicine and Computer Science seemapparently intangible domains, they collaborate each otherfor few decades. One of the faces of this cooperation is DataMining, a relative new and multidisciplinary field capable toextract valuable information from large sets of data. Despitethis fact, in cardiology related studies it was rarely used. Weassume that some data mining tools can be used as asubstitute for some complex, expensive, uncomfortable, timeconsuming, and sometimes dangerous medical examinations.This paper aims to show that cardiovascular diseases may bepredicted by classical risk factors analyzed and processed ina “non-invasive” way.

  11. Closing the knowledge gap on cardiovascular disease in type 2 diabetes: the EMPA-REG OUTCOME trial and beyond

    Directory of Open Access Journals (Sweden)

    Elif A Oral

    2016-09-01

    Full Text Available Type 2 diabetes mellitus (T2DM is associated with marked cardiovascular (CV morbidity and mortality, including heartfailure (HF. Until recently, an oral glucose-lowering agent that improved hyperglycemia as well as provided CV benefits in patients with T2DM and cardiovascular disease (CVD was lacking. The newest class of glucose-lowering agents, sodium glucose cotransporter 2 (SGLT2 inhibitors, includes canagliflozin, dapagliflozin, and empagliflozin. Prior to the release of the LEADER trial results, the recent EMPA-REG OUTCOME study was the only dedicated CV trial to demonstrate a reduction in major adverse cardiac events, CV mortality, and all-cause mortality and a reduction in hospitalization for HF with empagliflozin, given on top of standard-of-care therapy in patients with T2DM and CVD. This paper summarizes the results from EMPA-REG OUTCOME and discusses their significance and clinical implications.

  12. Mediterranean Diet and Cardiovascular Disease: A Critical Evaluation of A Priori Dietary Indexes

    OpenAIRE

    D’Alessandro, Annunziata; De Pergola, Giovanni

    2015-01-01

    The aim of this paper is to analyze the a priori dietary indexes used in the studies that have evaluated the role of the Mediterranean Diet in influencing the risk of developing cardiovascular disease. All the studies show that this dietary pattern protects against cardiovascular disease, but studies show quite different effects on specific conditions such as coronary heart disease or cerebrovascular disease. A priori dietary indexes used to measure dietary exposure imply quantitative and/or ...

  13. Positive effect on patient experience of video information given prior to cardiovascular magnetic resonance imaging: A clinical trial.

    Science.gov (United States)

    Ahlander, Britt-Marie; Engvall, Jan; Maret, Eva; Ericsson, Elisabeth

    2017-11-17

    To evaluate the effect of video information given before cardiovascular magnetic resonance imaging on patient anxiety and to compare patient experiences of cardiovascular magnetic resonance imaging versus myocardial perfusion scintigraphy. To evaluate whether additional information has an impact on motion artefacts. Cardiovascular magnetic resonance imaging and myocardial perfusion scintigraphy are technically advanced methods for the evaluation of heart diseases. Although cardiovascular magnetic resonance imaging is considered to be painless, patients may experience anxiety due to the closed environment. A prospective randomised intervention study, not registered. The sample (n = 148) consisted of 97 patients referred for cardiovascular magnetic resonance imaging, randomised to receive either video information in addition to standard text-information (CMR-video/n = 49) or standard text-information alone (CMR-standard/n = 48). A third group undergoing myocardial perfusion scintigraphy (n = 51) was compared with the cardiovascular magnetic resonance imaging-standard group. Anxiety was evaluated before, immediately after the procedure and 1 week later. Five questionnaires were used: Cardiac Anxiety Questionnaire, State-Trait Anxiety Inventory, Hospital Anxiety and Depression scale, MRI Fear Survey Schedule and the MRI-Anxiety Questionnaire. Motion artefacts were evaluated by three observers, blinded to the information given. Data were collected between April 2015-April 2016. The study followed the CONSORT guidelines. The CMR-video group scored lower (better) than the cardiovascular magnetic resonance imaging-standard group in the factor Relaxation (p = .039) but not in the factor Anxiety. Anxiety levels were lower during scintigraphic examinations compared to the CMR-standard group (p magnetic resonance imaging increased by adding video information prior the exam, which is important in relation to perceived quality in nursing. No effect was seen on motion

  14. Depression treatment after myocardial infarction and long-term risk of subsequent cardiovascular events and mortality : A randomized controlled trial

    NARCIS (Netherlands)

    Zuidersma, Marij; Conradi, Henk Jan; van Melle, Joost P.; Ormel, Johan; de Jonge, Peter

    Objective: Evaluating the effects of implementing an antidepressant treatment strategy in depressed myocardial infarction (MI)-patients on long-term cardiovascular outcomes and all-cause mortality. Methods: MI-patients were evaluated for the presence of a diagnosis of post-MI depression at 3, 6, 9

  15. Depression treatment after myocardial infarction and long-term risk of subsequent cardiovascular events and mortality: A randomized controlled trial

    NARCIS (Netherlands)

    Zuidersma, M.; Conradi, H.J.; van Melle, J.P.; Ormel, J.; de Jonge, P.

    2013-01-01

    Objective: Evaluating the effects of implementing an antidepressant treatment strategy in depressed myocardial infarction (MI)-patients on long-term cardiovascular outcomes and all-cause mortality. Methods: MI-patients were evaluated for the presence of a diagnosis of post-MI depression at 3, 6, 9

  16. [Psychological evaluation of uterus transplantation trial participants].

    Science.gov (United States)

    Chmel, Roman; Pastor, Zlatko; Nováčková, Marta; Matěcha, Jan; Čekal, Miloš; Zámečníková, Renata; Froněk, Jiří

    2017-01-01

    Uterus transplantation is a life-giving and quality-of-life enhancing transplantation. Life with transplanted uterus is a transitional phase of life for both recipients and their partners. Six deliveries of healthy children from five transplanted mothers out of 9 uterus transplantations in Sweden may encourage untimely hopes of thousands of women with absolute uterine factor infertility worldwide. Psychological evaluation might be included into all trials regarding new treatment methods and treatment procedures. Main psychological issues connected with the infertility treatment in women with absent uterus are clearly defined (especially in vitro fertilization, uterus transplantation, compliance with immunosuppressive treatment, ultrasound examinations of uterine vascular perfusion, rejection signs surveillance, embryo transfer, pregnancy, cesarean section, preterm delivery risk, puerperium, hysterectomy and immunosuppressive treatment termination). The role of psychological evaluation of participants before the admission to complicated treatment process is to choose those who will be able to cope all mentioned difficulties and unexpected complications including potential failure of the whole treatment without serious negative impact on their psychological situation. Up to now experience with psychological stability of our 7 uterus recipients and 3 uterus living donors are good although post-transplant period is especially in recipients connected with everyday psychological adaptation on the significant life changes. We are aware that psychological evaluation of our study participants will require further 3 years of follow up with publication of our results.

  17. Randomized controlled trials - mechanistic studies of testosterone and the cardiovascular system.

    Science.gov (United States)

    Jones, T Hugh; Kelly, Daniel M

    2018-02-09

    Testosterone deficiency is common in men with cardiovascular disease (CVD), and randomized placebo-controlled trials (RCTs) have reported beneficial effects of testosterone therapy on exercise-induced cardiac ischemia in chronic stable angina, functional exercise capacity, maximum oxygen consumption during exercise (VO 2max ) and muscle strength in chronic heart failure (CHF), shortening of the Q-T interval, and improvement of some cardiovascular risk factors. Testosterone deficiency is associated with an adverse CV risk profile and mortality. Clinical and scientific studies have provided mechanistic evidence to support and explain the findings of the RCTs. Testosterone is a rapid-onset arterial vasodilator within the coronary circulation and other vascular beds including the pulmonary vasculature and can reduce the overall peripheral systemic vascular resistance. Evidence has demonstrated that testosterone mediates this effect on vascular reactivity through calcium channel blockade (L-calcium channel) and stimulates potassium channel opening by direct nongenomic mechanisms. Testosterone also stimulates repolarization of cardiac myocytes by stimulating the ultra-rapid potassium channel-operated current. Testosterone improves cardiac output, functional exercise capacity, VO 2max and vagally mediated arterial baroreceptor cardiac reflex sensitivity in CHF, and other mechanisms. Independent of the benefit of testosterone on cardiac function, testosterone substitution may also increase skeletal muscle glucose metabolism and enhance muscular strength, both factors that could contribute to the improvement in functional exercise capacity may include improved glucose metabolism and muscle strength. Testosterone improves metabolic CV risk factors including body composition, insulin resistance, and hypercholesterolemia by improving both glucose utilization and lipid metabolism by a combination of genomic and nongenomic actions of glucose uptake and utilization expression of

  18. Randomized controlled trials – mechanistic studies of testosterone and the cardiovascular system

    Directory of Open Access Journals (Sweden)

    T Hugh Jones

    2018-01-01

    Full Text Available Testosterone deficiency is common in men with cardiovascular disease (CVD, and randomized placebo-controlled trials (RCTs have reported beneficial effects of testosterone therapy on exercise-induced cardiac ischemia in chronic stable angina, functional exercise capacity, maximum oxygen consumption during exercise (VO2max and muscle strength in chronic heart failure (CHF, shortening of the Q-T interval, and improvement of some cardiovascular risk factors. Testosterone deficiency is associated with an adverse CV risk profile and mortality. Clinical and scientific studies have provided mechanistic evidence to support and explain the findings of the RCTs. Testosterone is a rapid-onset arterial vasodilator within the coronary circulation and other vascular beds including the pulmonary vasculature and can reduce the overall peripheral systemic vascular resistance. Evidence has demonstrated that testosterone mediates this effect on vascular reactivity through calcium channel blockade (L-calcium channel and stimulates potassium channel opening by direct nongenomic mechanisms. Testosterone also stimulates repolarization of cardiac myocytes by stimulating the ultra-rapid potassium channel-operated current. Testosterone improves cardiac output, functional exercise capacity, VO2maxand vagally mediated arterial baroreceptor cardiac reflex sensitivity in CHF, and other mechanisms. Independent of the benefit of testosterone on cardiac function, testosterone substitution may also increase skeletal muscle glucose metabolism and enhance muscular strength, both factors that could contribute to the improvement in functional exercise capacity may include improved glucose metabolism and muscle strength. Testosterone improves metabolic CV risk factors including body composition, insulin resistance, and hypercholesterolemia by improving both glucose utilization and lipid metabolism by a combination of genomic and nongenomic actions of glucose uptake and utilization

  19. A walking program for people with severe knee osteoarthritis did not reduce pain but may have benefits for cardiovascular health: a phase II randomised controlled trial.

    Science.gov (United States)

    Wallis, J A; Webster, K E; Levinger, P; Singh, P J; Fong, C; Taylor, N F

    2017-12-01

    The primary aim was to evaluate the effect of a dosed walking program on knee pain for patients with severe knee osteoarthritis (OA). Secondary aims evaluated the effects on cardiovascular health, function and quality of life. Participants with severe knee OA and increased cardiovascular risk were randomly assigned to a 12-week walking program of 70 min/week of at least moderate intensity, or to usual care. The primary outcome was knee pain (0-10). Secondary outcomes were of cardiovascular risk including physical activity, blood pressure, blood lipid and glucose levels, body mass index and waist circumference; WOMAC Index scores; physical function; and quality of life. Forty-six participants (23 each group) were recruited. Sixteen participants (70%) adhered to the walking program. Intention to treat analysis showed no between-group difference in knee pain. The walking group had increased odds of achieving a healthy systolic blood pressure (OR = 5.7, 95% CI 1.2-26.9), and a faster walking speed (Mean Difference (MD) = 0.12 m/s, 95% CI 0.02-0.23). Per protocol analysis based on participant adherence showed the walking group had more daily steps (MD = 1345 steps, 95% CI 365-2325); more time walking (MD = 18 min/day, 95% CI 5-31); reduced waist circumference (MD = -5.3 cm, 95% CI -10.5 to -0.03); and increased knee stiffness (MD = 0.9 units, 95% CI 0.07-1.8). Patients with severe knee OA prescribed a 12-week walking program of 70 min/week may have had cardiovascular benefits without decreasing knee pain. Australian New Zealand Clinical Trials Registry ACTRN12615000015549. Copyright © 2016 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  20. NHS health checks through general practice: randomised trial of population cardiovascular risk reduction

    Directory of Open Access Journals (Sweden)

    Cochrane Thomas

    2012-11-01

    Full Text Available Abstract Background The global burden of the major vascular diseases is projected to rise and to remain the dominant non-communicable disease cluster well into the twenty first century. The Department of Health in England has developed the NHS Health Check service as a policy initiative to reduce population vascular disease risk. The aims of this study were to monitor population changes in cardiovascular disease (CVD risk factors over the first year of the new service and to assess the value of tailored lifestyle support, including motivational interview with ongoing support and referral to other services. Methods Randomised trial comparing NHS Health Check service only with NHS Health Check service plus additional lifestyle support in Stoke on Trent, England. Thirty eight general practices and 601 (365 usual care, 236 additional lifestyle support patients were recruited and randomised independently between September 2009 and February 2010. Changes in population CVD risk between baseline and one year follow-up were compared, using intention-to-treat analysis. The primary outcome was the Framingham 10 year CVD risk score. Secondary outcomes included individual modifiable risk measures and prevalence of individual risk categories. Additional lifestyle support included referral to a lifestyle coach and free sessions as needed for: weight management, physical activity, cook and eat and positive thinking. Results Average population CVD risk decreased from 32.9% to 29.4% (p Conclusions The NHS Health Check service in Stoke on Trent resulted in significant reduction in estimated population CVD risk. There was no evidence of further benefit of the additional lifestyle support services in terms of absolute CVD risk reduction.

  1. Plasma lipidome patterns associated with cardiovascular risk in the PREDIMED trial: A case-cohort study.

    Science.gov (United States)

    Razquin, Cristina; Liang, Liming; Toledo, Estefanía; Clish, Clary B; Ruiz-Canela, Miguel; Zheng, Yan; Wang, Dong D; Corella, Dolores; Castaner, Olga; Ros, Emilio; Aros, Fernando; Gomez-Gracia, Enrique; Fiol, Miquel; Santos-Lozano, José Manuel; Guasch-Ferre, Marta; Serra-Majem, Lluis; Sala-Vila, Aleix; Buil-Cosiales, Pilar; Bullo, Monica; Fito, Montserrat; Portoles, Olga; Estruch, Ramon; Salas-Salvado, Jordi; Hu, Frank B; Martinez-Gonzalez, Miguel A

    2018-02-15

    The study of the plasma lipidome may help to better characterize molecular mechanisms underlying cardiovascular disease. The identification of new lipid biomarkers could provide future targets for prevention and innovative therapeutic approaches. In the frame of the PREDIMED trial, our aim was to examine the associations of baseline lipidome patterns or their changes with the risk of clinical CVD events. We included 983 participants in our case-cohort study. The end-point was the incidence of major CVD during 4.8years of median follow-up. We repeatedly measured 202 plasma known lipid metabolites at baseline and after 1-year of intervention. Principal component analysis was used to identify lipidome factors. Among the 15 identified factors, 7 were significantly associated with CVD. Considering common patterns among factors, lipids were grouped (summed) into scores. After adjustment for traditional CVD risk factors, scores of baseline polyunsaturated phosphatidylcholines (PC)/lysoPC/PC-plasmalogens and polyunsaturated cholesterol esters (CE) showed inverse associations with CVD (p=0.036 and 0.012, respectively); whereas scores of monoacylglycerols (MAGs)/diacylglycerols (DAGs) and short triacylglycerols (TAGs) showed a direct association with CVD (p=0.026 and 0.037, respectively). Baseline phosphatidylethanolamines (PEs) and their 1-y changes tended to be associated with higher CVD risk (p=0.066 and 0.081, respectively). We did not find a significant effect of the intervention with the Mediterranean Diet on these scores. Our study suggests that polyunsaturated PCs and CEs may confer protection against CVD. In contrast, MAGs, DAGs, TAGs and PEs appeared to be associated with higher CVD risk. Copyright © 2017 Elsevier B.V. All rights reserved.

  2. Risks of cardiovascular or central nervous system adverse events and immune reconstitution inflammatory syndrome, for dolutegravir versus other antiretrovirals: meta-analysis of randomized trials.

    Science.gov (United States)

    Hill, Andrew M; Mitchell, Nikkita; Hughes, Sophie; Pozniak, Anton L

    2018-03-01

    Results from nonrandomized cohort studies suggest higher risks of CNS adverse events for dolutegravir, versus other ARVs. There have been two case reports of myocarditis on dolutegravir. Integrase inhibitors have been associated with IRIS in two cohort studies. Meta-analysis of randomized trials can be used to cross-check potential safety signals. This systematic review of drug safety used an EMBASE and MEDLINE search combined with serious adverse event (SAE) reports on the website www.clinicaltrials.gov. Cardiovascular, CNS or IRIS-associated adverse events were analysed for dolutegravir versus other ARVs. Relative risks for the comparison between dolutegravir and other antiretrovirals were calculated for each adverse event. Meta-analyses applied Mantel-Haenszel random-effects models. There was a higher risk of Grade 1-4 insomnia adverse events for DTG (6.1%) versus other ARVs (4.5%; P = 0.02). There was no significant difference between DTG and other ARVs in the risk of cardiovascular serious adverse events. In the SINGLE and SPRING-1 trials comparing DTG with efavirenz, there were 5/465 patients with reported suicidality SAEs on DTG (1.1%) versus 6/469 (1.3%) on EFV. In other studies, serious adverse events of suicidality were reported for 15/2250 patients on DTG (0.7%) versus 9/2257 patients on other ARVs (0.4%). Risks of IRIS were low, but event rates were low and the main trials excluded CDC stage C disease. In this meta-analysis, there was no significant effect of dolutegravir on the risk of cardiac, IRIS or suicide-related serious adverse events. There was a higher risk of insomnia for DTG. Other completed randomized trials should be included in new evaluations of DTG safety. Continued pharmacovigilance, with regular meta-analyses, should be used to monitor safety.

  3. Baseline comparison of three health utility measures and the feeling thermometer among participants in the action to control cardiovascular risk in diabetes trial

    Directory of Open Access Journals (Sweden)

    Raisch Dennis W

    2012-07-01

    Full Text Available Abstract Background Health utility (HU measures are used as overall measures of quality of life and to determine quality adjusted life years (QALYs in economic analyses. We compared baseline values of three HUs including Short Form 6 Dimensions (SF-6D, and Health Utilities Index, Mark II and Mark III (HUI2 and HUI3 and the feeling thermometer (FT among type 2 diabetes participants in the Action to Control Cardiovascular Risk in Diabetes (ACCORD trial. We assessed relationships between HU and FT values and patient demographics and clinical variables. Methods ACCORD was a randomized clinical trial to test if intensive controls of glucose, blood pressure and lipids can reduce the risk of major cardiovascular disease (CVD events in type 2 diabetes patients with high risk of CVD. The health-related quality of life (HRQOL sub-study includes 2,053 randomly selected participants. Interclass correlations (ICCs and agreement between measures by quartile were used to evaluate relationships between HU’s and the FT. Multivariable regression models specified relationships between patient variables and each HU and the FT. Results The ICCs were 0.245 for FT/SF-6D, 0.313 for HUI3/SF-6D, 0.437 for HUI2/SF-6D, 0.338 for FT/HUI2, 0.337 for FT/HUI3 and 0.751 for HUI2/HUI3 (P P P  Conclusions The agreements between the different HUs were poor except for the two HUI measures; therefore HU values derived different measures may not be comparable. The FT had low agreement with HUs. The relationships between HUs and demographic and clinical measures demonstrate how severity of diabetes and other clinical and demographic factors are associated with HUs and FT measures. Trial registration ClinicalTrials.gov Identifier: NCT00000620

  4. Cost-effectiveness analysis of adding pharmacists to primary care teams to reduce cardiovascular risk in patients with Type 2 diabetes: results from a randomized controlled trial.

    Science.gov (United States)

    Simpson, S H; Lier, D A; Majumdar, S R; Tsuyuki, R T; Lewanczuk, R Z; Spooner, R; Johnson, J A

    2015-07-01

    Adding pharmacists to primary care teams significantly improved blood pressure control and reduced predicted 10-year cardiovascular risk in patients with Type 2 diabetes. This pre-specified sub-study evaluated the economic implications of this cardiovascular risk reduction strategy. One-year outcomes and healthcare utilization data from the trial were used to determine cost-effectiveness from the public payer perspective. Costs were expressed in 2014 Canadian dollars and effectiveness was based on annualized risk of cardiovascular events derived from the UKPDS Risk Engine. The 123 evaluable trial patients included in this analysis had a mean age of 62 ( ± 11) years, 38% were men, and mean diabetes duration was 6 ( ± 7) years. Pharmacists provided 3.0 ( ± 1.9) hours of additional service to each intervention patient, which cost $226 ( ± $1143) per patient. The overall one-year per-patient costs for healthcare utilization were $190 lower in the intervention group compared with usual care [95% confidence interval (CI): -$1040, $668). Intervention patients had a significant 0.3% greater reduction in the annualized risk of a cardiovascular event (95% CI: 0.08%, 0.6%) compared with usual care. In the cost-effectiveness analysis, the intervention dominated usual care in 66% of 10,000 bootstrap replications. At a societal willingness-to-pay of $4000 per 1% reduction in annual cardiovascular risk, the probability that the intervention was cost-effective compared with usual care reached 95%. A sensitivity analysis using multiple imputation to replace missing data produced similar results. Within a randomized trial, adding pharmacists to primary care teams was a cost-effective strategy for reducing cardiovascular risk in patients with Type 2 diabetes. In most circumstances, this intervention may also be cost saving. © 2015 The Authors. Diabetic Medicine © 2015 Diabetes UK.

  5. Evaluation of an improved technique for automated center lumen line definition in cardiovascular image data

    International Nuclear Information System (INIS)

    Gratama van Andel, Hugo A.F.; Meijering, Erik; Vrooman, Henri A.; Stokking, Rik; Lugt, Aad van der; Monye, Cecile de

    2006-01-01

    The aim of the study was to evaluate a new method for automated definition of a center lumen line in vessels in cardiovascular image data. This method, called VAMPIRE, is based on improved detection of vessel-like structures. A multiobserver evaluation study was conducted involving 40 tracings in clinical CTA data of carotid arteries to compare VAMPIRE with an established technique. This comparison showed that VAMPIRE yields considerably more successful tracings and improved handling of stenosis, calcifications, multiple vessels, and nearby bone structures. We conclude that VAMPIRE is highly suitable for automated definition of center lumen lines in vessels in cardiovascular image data. (orig.)

  6. Evaluation of a cardiovascular Risk Reduction Program at a workplace medical clinic.

    Science.gov (United States)

    Andres, Kara L; Renn, Tracy A; Gray, David A; Englund, Joanne M; Olsen, Geary W; Letourneau, Barbara K

    2013-10-01

    The Cardiovascular Risk Reduction Program (CVRRP) was implemented in the 3M Medical Clinic in December 2009. The goal of the CVRRP was to evaluate 3M employees at risk for developing cardiovascular disease (CVD) and address any related modifiable risk factors with appropriate intervention strategies through clinic visits with a 3M nurse practitioner or physician and, if needed, a registered dietitian and/or exercise professional. Data for the first 100 participants were analyzed to initially assess the effectiveness of the program. Based on this evaluation, the 3M CVRRP and active collaboration between participants and providers in the workplace successfully reduced modifiable CVD risk factors. Copyright 2013, SLACK Incorporated.

  7. Evaluation of malposition of the branch pulmonary arteries using cardiovascular computed tomography angiography

    International Nuclear Information System (INIS)

    Liu, Hui; Juan, Yu-Hsiang; Wang, Qiushi; Huang, Hongfei; Yang, Lin; Xie, Zhaofeng; Chen, Jimei; Zhang, Xiaoshen; Liang, Changhong; Chung, Taylor; Kwong, Raymond Y.; Saboo, Sachin S.

    2014-01-01

    To analyze 15 cases of malposition of branch pulmonary arteries (MBPA) for the hospital-based prevalence, clinical information, surgical outcome, imaging findings, associated cardiovascular and airway abnormalities on cardiovascular computed tomography angiography (CCTA). We retrospectively searched for patients with MBPA from our database consisting of patients referred for CCTA due to known or suspected congenital heart disease and also from all patients receiving chest computed tomography (CT) during the same time period. We analyzed the hospital-based prevalence, image findings, associated cardiovascular anomalies, airway compression, and recorded the clinical information and surgical outcome. Our study showed 15 patients with MBPA (hospital-based prevalence: 0.33 % among patients with congenital heart disease and 0.06 % in all patients receiving chest CT or CCTA). Classic type was more common than lesser type (67 % versus 33 %). All patients had associated cardiovascular anomalies, including aortic arch abnormalities (80 %) and secondary airway compression (33 %). Surgery was performed in 67 % of cardiovascular anomalies and 60 % of airway stenoses. MBPA has a hospital-based prevalence of 0.33 % among patients with congenital heart disease and 0.06 % in all patients receiving either chest CT or CCTA. CCTA can delineate the anatomy of MBPA, associated cardiovascular and airway abnormalities for preoperative evaluation. (orig.)

  8. Evaluation of malposition of the branch pulmonary arteries using cardiovascular computed tomography angiography

    Energy Technology Data Exchange (ETDEWEB)

    Liu, Hui [Guangdong Academy of Medical Sciences, Department of Radiology, Guangdong General Hospital, GuangZhou, GuangDong (China); Brigham and Women' s Hospital, Harvard Medical School, Cardiovascular Imaging Program, Department of Medicine (Division of Cardiovascular Medicine) and Radiology, Boston, MA (United States); Juan, Yu-Hsiang [Brigham and Women' s Hospital, Harvard Medical School, Cardiovascular Imaging Program, Department of Medicine (Division of Cardiovascular Medicine) and Radiology, Boston, MA (United States); Chang Gung Memorial Hospital, Linkou and Chang Gung University, Department of Medical Imaging and Intervention, Taoyuan (China); Wang, Qiushi; Huang, Hongfei; Yang, Lin [Guangdong Academy of Medical Sciences, Department of Radiology, Guangdong General Hospital, GuangZhou, GuangDong (China); Xie, Zhaofeng [Guangdong Academy of Medical Sciences, Department of Pediatric Cardiology, Guangdong General Hospital, GuangZhou, GuangDong (China); Chen, Jimei; Zhang, Xiaoshen [Guangdong Academy of Medical Sciences, Department of Cardiovascular Surgery, Guangdong General Hospital, GuangZhou, GuangDong (China); Liang, Changhong [Guangdong Academy of Medical Sciences, Department of Radiology, Guangdong General Hospital, GuangZhou, GuangDong (China); Guangdong Academy of Medical Sciences, Department of Radiology, Guangdong General Hospital, Guangzhou (China); Chung, Taylor [Children' s Hospital and Research Center Oakland, Department of Diagnostic Imaging, Oakland, CA (United States); Kwong, Raymond Y.; Saboo, Sachin S. [Brigham and Women' s Hospital, Harvard Medical School, Cardiovascular Imaging Program, Department of Medicine (Division of Cardiovascular Medicine) and Radiology, Boston, MA (United States)

    2014-12-15

    To analyze 15 cases of malposition of branch pulmonary arteries (MBPA) for the hospital-based prevalence, clinical information, surgical outcome, imaging findings, associated cardiovascular and airway abnormalities on cardiovascular computed tomography angiography (CCTA). We retrospectively searched for patients with MBPA from our database consisting of patients referred for CCTA due to known or suspected congenital heart disease and also from all patients receiving chest computed tomography (CT) during the same time period. We analyzed the hospital-based prevalence, image findings, associated cardiovascular anomalies, airway compression, and recorded the clinical information and surgical outcome. Our study showed 15 patients with MBPA (hospital-based prevalence: 0.33 % among patients with congenital heart disease and 0.06 % in all patients receiving chest CT or CCTA). Classic type was more common than lesser type (67 % versus 33 %). All patients had associated cardiovascular anomalies, including aortic arch abnormalities (80 %) and secondary airway compression (33 %). Surgery was performed in 67 % of cardiovascular anomalies and 60 % of airway stenoses. MBPA has a hospital-based prevalence of 0.33 % among patients with congenital heart disease and 0.06 % in all patients receiving either chest CT or CCTA. CCTA can delineate the anatomy of MBPA, associated cardiovascular and airway abnormalities for preoperative evaluation. (orig.)

  9. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial

    Science.gov (United States)

    2011-01-01

    Background Periodontal disease (PD) is an infectious clinical entity characterized by the destruction of supporting tissues of the teeth as the result of a chronic inflammatory response in a susceptible host. It has been proposed that PD as subclinical infection may contribute to the etiology and to the pathogenesis of several systemic diseases including Atherosclerosis. A number of epidemiological studies link periodontal disease/edentulism as independent risk factor for acute myocardial infarction, peripheral vascular disease, and cerebrovascular disease. Moreover, new randomized controlled clinical trials have shown an improvement on cardiovascular surrogate markers (endothelial function, sICAM, hsPCR level, fibrinogen) after periodontal treatment. Nonetheless, such trials are still limited in terms of external validity, periodontal treatment strategies, CONSORT-based design and results consistency/extrapolation. The current study is designed to evaluate if periodontal treatment with scaling and root planning plus local delivered chlorhexidine improves endothelial function and other biomarkers of cardiovascular disease in subjects with moderate to severe periodontitis. Methods/Design This randomized, single-blind clinical trial will be performed at two health centers and will include two periodontal treatment strategies. After medical/periodontal screening, a baseline endothelium-dependent brachial artery flow-mediated dilatation (FMD) and other systemic surrogate markers will be obtained from all recruited subjects. Patients then will be randomized to receive either supragingival/subgingival plaque cleaning and calculus removal plus chlorhexidine (treatment group) or supragingival plaque removal only (control group). A second and third FMD will be obtained after 24 hours and 12 weeks in both treatment arms. Each group will consist of 49 patients (n = 98) and all patients will be followed-up for secondary outcomes and will be monitored through a coordinating

  10. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Arce Roger M

    2011-02-01

    Full Text Available Abstract Background Periodontal disease (PD is an infectious clinical entity characterized by the destruction of supporting tissues of the teeth as the result of a chronic inflammatory response in a susceptible host. It has been proposed that PD as subclinical infection may contribute to the etiology and to the pathogenesis of several systemic diseases including Atherosclerosis. A number of epidemiological studies link periodontal disease/edentulism as independent risk factor for acute myocardial infarction, peripheral vascular disease, and cerebrovascular disease. Moreover, new randomized controlled clinical trials have shown an improvement on cardiovascular surrogate markers (endothelial function, sICAM, hsPCR level, fibrinogen after periodontal treatment. Nonetheless, such trials are still limited in terms of external validity, periodontal treatment strategies, CONSORT-based design and results consistency/extrapolation. The current study is designed to evaluate if periodontal treatment with scaling and root planning plus local delivered chlorhexidine improves endothelial function and other biomarkers of cardiovascular disease in subjects with moderate to severe periodontitis. Methods/Design This randomized, single-blind clinical trial will be performed at two health centers and will include two periodontal treatment strategies. After medical/periodontal screening, a baseline endothelium-dependent brachial artery flow-mediated dilatation (FMD and other systemic surrogate markers will be obtained from all recruited subjects. Patients then will be randomized to receive either supragingival/subgingival plaque cleaning and calculus removal plus chlorhexidine (treatment group or supragingival plaque removal only (control group. A second and third FMD will be obtained after 24 hours and 12 weeks in both treatment arms. Each group will consist of 49 patients (n = 98 and all patients will be followed-up for secondary outcomes and will be monitored

  11. Coronary Artery Disease Evaluation in Rheumatoid Arthritis (CADERA): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Erhayiem, Bara; Pavitt, Sue; Baxter, Paul; Andrews, Jacqueline; Greenwood, John P; Buch, Maya H; Plein, Sven

    2014-11-08

    The incidence of cardiovascular disease (CVD) in rheumatoid arthritis (RA) is increased compared to the general population. Immune dysregulation and systemic inflammation are thought to be associated with this increased risk. Early diagnosis with immediate treatment and tight control of RA forms a central treatment paradigm. It remains unclear, however, whether using tumor necrosis factor inhibitors (TNFi) to achieve remission confer additional beneficial effects over standard therapy, especially on the development of CVD. Coronary Artery Disease Evaluation in Rheumatoid Arthritis (CADERA) is a prospective cardiovascular imaging study that bolts onto an existing single-centre, randomized controlled trial, VEDERA (Very Early versus Delayed Etanercept in Rheumatoid Arthritis). VEDERA will recruit 120 patients with early, treatment-naïve RA, randomized to TNFi therapy etanercept (ETN) combined with methotrexate (MTX), or therapy with MTX with or without additional synthetic disease modifying anti-rheumatic drugs with escalation to ETN following a 'treat-to-target' regimen. VEDERA patients will be recruited into CADERA and undergo cardiac magnetic resonance (CMR) assessment with; cine imaging, rest/stress adenosine perfusion, tissue-tagging, aortic distensibility, T1 mapping and late gadolinium imaging. Primary objectives are to detect the prevalence and change of cardiovascular abnormalities by CMR between TNFi and standard therapy over a 12-month period. All patients will enter an inflammatory arthritis registry for long-term follow-up. CADERA is a multi-parametric study describing cardiovascular abnormalities in early, treatment-naïve RA patients, with assessment of changes at one year between early biological therapy and conventional therapy. This trial was registered with Current Controlled Trials (registration number: ISRCTN50167738) on 8 November 2013.

  12. Rationale and design of the Kanyini guidelines adherence with the polypill (Kanyini-GAP study: a randomised controlled trial of a polypill-based strategy amongst Indigenous and non Indigenous people at high cardiovascular risk

    Directory of Open Access Journals (Sweden)

    Usherwood Tim

    2010-08-01

    Full Text Available Abstract Background The Kanyini Guidelines Adherence with the Polypill (Kanyini-GAP Study aims to examine whether a polypill-based strategy (using a single capsule containing aspirin, a statin and two blood pressure-lowering agents amongst Indigenous and non-Indigenous people at high risk of experiencing a cardiovascular event will improve adherence to guideline-indicated therapies, and lower blood pressure and cholesterol levels. Methods/Design The study is an open, randomised, controlled, multi-centre trial involving 1000 participants at high risk of cardiovascular events recruited from mainstream general practices and Aboriginal Medical Services, followed for an average of 18 months. The participants will be randomised to one of two versions of the polypill, the version chosen by the treating health professional according to clinical features of the patient, or to usual care. The primary study outcomes will be changes, from baseline measures, in serum cholesterol and systolic blood pressure and self-reported current use of aspirin, a statin and at least two blood pressure lowering agents. Secondary study outcomes include cardiovascular events, renal outcomes, self-reported barriers to indicated therapy, prescription of indicated therapy, occurrence of serious adverse events and changes in quality-of-life. The trial will be supplemented by formal economic and process evaluations. Discussion The Kanyini-GAP trial will provide new evidence as to whether or not a polypill-based strategy improves adherence to effective cardiovascular medications amongst individuals in whom these treatments are indicated. Trial Registration This trial is registered with the Australian New Zealand Clinical Trial Registry ACTRN126080005833347.

  13. Dry weight assessment by combined ultrasound and bioimpedance monitoring in low cardiovascular risk hemodialysis patients: a randomized controlled trial.

    Science.gov (United States)

    Siriopol, Dimitrie; Onofriescu, Mihai; Voroneanu, Luminita; Apetrii, Mugurel; Nistor, Ionut; Hogas, Simona; Kanbay, Mehmet; Sascau, Radu; Scripcariu, Dragos; Covic, Adrian

    2017-01-01

    Fluid overload is associated with adverse outcomes in hemodialysis (HD) patients. The precise assessment of hydration status in HD patients remains a major challenge for nephrologists. Our study aimed to explore whether combining two bedside methods, lung ultrasonography (LUS) and bioimpedance, may provide complementary information to guide treatment in specific HD patients. In total, 250 HD patients from two dialysis units were included in this randomized clinical trial. Patients were randomized 1:1 to have a dry weight assessment based on clinical (control) or LUS with bioimpedance in case of clinical hypovolemia (active)-guided protocol. The primary outcome was to assess the difference between the two groups on a composite of all-cause mortality and first cardiovascular event (CVE)-including death, stroke, and myocardial infarction. During a mean follow-up period was 21.3 ± 5.6 months, there were 54 (21.6%) composite events in the entire population. There was a nonsignificant 9% increase in the risk of this outcome in the active arm (HR = 1.09, 95% CI 0.64-1.86, p = 0.75). Similarly, there were no differences between the two groups when analyzing separately the all-cause mortality and CVE outcomes. However, patients in the active arm had a 19% lower relative risk of pre-dialytic dyspnea (rate ratio-0.81, 95% CI 0.68-0.96), but a 26% higher relative risk of intradialytic cramps (rate ratio-1.26, 95% CI 1.16-1.37). This study shows that a LUS-bioimpedance-guided dry weight adjustment protocol, as compared to clinical evaluation, does not reduce all-cause mortality and/or CVE in HD patients. A fluid management protocol based on bioimpedance with LUS on indication might be a better strategy.

  14. Very low levels of atherogenic lipoproteins and the risk for cardiovascular events: a meta-analysis of statin trials

    NARCIS (Netherlands)

    Boekholdt, S. Matthijs; Hovingh, G. Kees; Mora, Samia; Arsenault, Benoit J.; Amarenco, Pierre; Pedersen, Terje R.; LaRosa, John C.; Waters, David D.; Demicco, David A.; Simes, R. John; Keech, Antony C.; Colquhoun, David; Hitman, Graham A.; Betteridge, D. John; Clearfield, Michael B.; Downs, John R.; Colhoun, Helen M.; Gotto, Antonio M.; Ridker, Paul M.; Grundy, Scott M.; Kastelein, John J. P.

    2014-01-01

    Levels of atherogenic lipoproteins achieved with statin therapy are highly variable, but the consequence of this variability for cardiovascular disease risk is not well-documented. The aim of this meta-analysis was to evaluate: 1) the interindividual variability of reductions in low-density

  15. Heart failure as an endpoint in heart failure and non-heart failure cardiovascular clinical trials: the need for a consensus definition

    DEFF Research Database (Denmark)

    Zannad, F.; Stough, W.G.; Pitt, B.

    2008-01-01

    Specific criteria have been established to define the occurrence of myocardial infarction (MI) and stroke in cardiovascular clinical trials, but there is not a consistent definition for heart failure. Heart failure events appear to occur at a rate that is similar to stroke and MI in trials...... of hypertension, hyperlipidaemia, diabetes, and coronary heart disease, yet a consistent approach to defining heart failure events has not yet been realized. The wide range of definitions used in clinical trials makes it difficult to interpret new data in the context of existing literature. This inconsistency has...... led to challenges in determining the incidence of heart failure in cardiovascular studies and the effects of interventions on these endpoints. This paper examines issues related to defining heart failure events in cardiovascular clinical trials and presents a definition to formally address this issue...

  16. Heart failure as an endpoint in heart failure and non-heart failure cardiovascular clinical trials: the need for a consensus definition

    DEFF Research Database (Denmark)

    Zannad, F.; Stough, W.G.; Pitt, B.

    2008-01-01

    of hypertension, hyperlipidaemia, diabetes, and coronary heart disease, yet a consistent approach to defining heart failure events has not yet been realized. The wide range of definitions used in clinical trials makes it difficult to interpret new data in the context of existing literature. This inconsistency has......Specific criteria have been established to define the occurrence of myocardial infarction (MI) and stroke in cardiovascular clinical trials, but there is not a consistent definition for heart failure. Heart failure events appear to occur at a rate that is similar to stroke and MI in trials...... led to challenges in determining the incidence of heart failure in cardiovascular studies and the effects of interventions on these endpoints. This paper examines issues related to defining heart failure events in cardiovascular clinical trials and presents a definition to formally address this issue...

  17. Evaluation of a Cardiovascular Health Program for Participants with Mental Retardation and Normal Learners

    Science.gov (United States)

    Ewing, Gary; McDermott, Suzanne; Thomas-Koger, Marlo; Whitner, Wendy; Pierce, Kristen

    2004-01-01

    An evaluation was conducted to compare the impact of an 8-week cardiovascular disease risk reduction group teaching program for 92 individuals with mental retardation (MR; IQ less than 70) and 97 normal learners. The curriculum emphasized exercise, nutritional choices, and stress reduction. Body Mass Index (BMI; weight in kilograms, divided by…

  18. Appraisal, Coping, Task Performance, and Cardiovascular Responses during the Evaluated Speaking Task.

    Science.gov (United States)

    Baggett, H. Lane; And Others

    1996-01-01

    Appraisal, coping, task performance, and cardiovascular responses were examined among men high and low in speech anxiety who prepared and performed a speech under evaluative conditions. Speech-anxious men saw the task as more threatening. They were more stressed, anxious, distracted, and aware of their emotions, focused on the passage of time, and…

  19. Expert consensus for multi-modality imaging evaluation of cardiovascular complications of radiotherapy in adults

    DEFF Research Database (Denmark)

    Lancellotti, Patrizio; Nkomo, Vuyisile T; Badano, Luigi P

    2013-01-01

    . A comprehensive review of potential cardiac complications related to radiotherapy is warranted. An evidence-based review of several imaging approaches used to detect, evaluate, and monitor RIHD is discussed. Recommendations for the early identification and monitoring of cardiovascular complications...... of radiotherapy by cardiac imaging are also proposed....

  20. Cardiovascular safety of non-insulin pharmacotherapy for type 2 diabetes

    OpenAIRE

    Xu, James; Rajaratnam, Rohan

    2017-01-01

    Patients with type 2 diabetes mellitus have a twofold increased risk of cardiovascular mortality compared with non-diabetic individuals. There is a growing awareness that glycemic efficacy of anti-diabetic drugs does not necessarily translate to cardiovascular safety. Over the past few years, there has been a number of trials evaluating the cardiovascular effects of anti-diabetic drugs. In this review, we seek to examine the cardiovascular safety of these agents in major published trials. Met...

  1. Efficacy of n-3 polyunsaturated fatty acids and feasibility of optimizing preventive strategies in patients at high cardiovascular risk: rationale, design and baseline characteristics of the Rischio and Prevenzione study, a large randomised trial in general practice

    Directory of Open Access Journals (Sweden)

    2010-05-01

    Full Text Available Abstract Background The optimization of preventive strategies in patients at high risk of cardiovascular events and the evaluation of bottlenecks and limitations of transferring current guidelines to the real world of clinical practice are important limiting steps to cardiovascular prevention. Treatment with n-3 polyunsaturated fatty acids improves prognosis after myocardial infarction, but evidence of this benefit is lacking in patients at high cardiovascular risk, but without a history of myocardial infarction. Methods/design Patients were eligible if their general practitioner (GP considered them at high cardiovascular risk because of a cardiovascular disease other than myocardial infarction, or multiple risk factors (at least four major risk factors in non-diabetic patients and one in diabetics. Patients were randomly allocated to treatment with n-3 polyunsaturated fatty acids (1 g daily or placebo in a double-blind study and followed up for five years by their GPs to assess the efficacy of the treatment in preventing cardiovascular mortality (including sudden death and hospitalization for cardiovascular reasons. The secondary, epidemiological, aim of the study is to assess whether it is feasible to adopt current guidelines in everyday clinical practice, with a view to optimizing all the available preventive strategies in people at high cardiovascular risk. A nation-wide network of 860 GPs admitted 12,513 patients to the study between February 2004 and March 2007. The mean age was 64 years and 62% were males. Diabetes mellitus plus one or more cardiovascular risk factors was the main inclusion criterion (47%. About 30% of patients were included because of a history of atherosclerotic cardiovascular disease, 21% for four or more risk factors, and less than 1% for other reasons. Discussion The Rischio and Prevenzione (R&P project provides a feasible model to test the efficacy of n-3 polyunsaturated fatty acid therapy in patients at high

  2. Cost-effectiveness of telehealth for patients with raised cardiovascular disease risk: evidence from the Healthlines randomised controlled trial.

    Science.gov (United States)

    Dixon, Padraig; Hollinghurst, Sandra; Edwards, Louisa; Thomas, Clare; Gaunt, Daisy; Foster, Alexis; Large, Shirley; Montgomery, Alan A; Salisbury, Chris

    2016-08-26

    To investigate the cost-effectiveness of a telehealth intervention for primary care patients with raised cardiovascular disease (CVD) risk. A prospective within-trial patient-level economic evaluation conducted alongside a randomised controlled trial. Patients recruited through primary care, and intervention delivered via telehealth service. Adults with a 10-year CVD risk ≥20%, as measured by the QRISK2 algorithm, with at least 1 modifiable risk factor. A series of up to 13 scripted, theory-led telehealth encounters with healthcare advisors, who supported participants to make behaviour change, use online resources, optimise medication and improve adherence. Participants in the control arm received usual care. Cost-effectiveness measured by net monetary benefit at the end of 12 months of follow-up, calculated from incremental cost and incremental quality-adjusted life years (QALYs). Productivity impacts, participant out-of-pocket expenditure and the clinical outcome were presented in a cost-consequences framework. 641 participants were randomised-325 to receive the telehealth intervention in addition to usual care and 316 to receive only usual care. 18% of participants had missing data on either costs, utilities or both. Multiple imputation was used for the base case results. The intervention was associated with incremental mean per-patient National Health Service (NHS) costs of £138 (95% CI 66 to 211) and an incremental QALY gain of 0.012 (95% CI -0.001 to 0.026). The incremental cost-effectiveness ratio was £10 859. Net monetary benefit at a cost-effectiveness threshold of £20 000 per QALY was £116 (95% CI -58 to 291), and the probability that the intervention was cost-effective at this threshold value was 0.77. Similar results were obtained from a complete case analysis. There is evidence to suggest that the Healthlines telehealth intervention was likely to be cost-effective at a threshold of £20 000 per QALY. ISRCTN27508731; Results. Prospectively

  3. A randomized controlled trial of exercise training on cardiovascular and autonomic function among renal transplant recipients.

    Science.gov (United States)

    Kouidi, Evangelia; Vergoulas, George; Anifanti, Maria; Deligiannis, Asterios

    2013-05-01

    There are conflicting data regarding the effects of renal transplantation (RT) on uraemic autonomic dysfunction. Moreover, no study has examined the impact of physical training on the cardiac autonomic function in RT patients. Thus, we studied the effects of exercise training on heart rate variability (HRV) and arterial baroreflex sensitivity (BRS), which are sensitive markers of cardiac autonomic outflow, in RT recipients. Eleven patients (Exercise group-aged 52.1 ± 5.6 years) were studied before and after 6 months of exercise training. Twelve age- and sex- matched RT patients (Sedentary) and 12 healthy sedentary individuals (Healthy), who remained untrained, served as controls. At baseline and follow-up, all the subjects underwent cardiopulmonary exercise testing for the evaluation of peak oxygen consumption (VO2peak), a tilt test for the evaluation of BRS and baroreflex effectiveness index (BEI) and an ambulatory 24-h Holter monitoring for time- and frequency-domain measures of HRV. In the exercise group, VO2peak increased by 15.8% (P training. Specifically, the standard deviation of all normal-to-normal (NN) intervals (SDNN) significantly increased by 92.5%, the root-mean-square of the differences between consecutive NN intervals by 45.4%, the percentage value of NN50 count by 58.2%, the high-frequency by 74.8% and low-frequency spectral power by 41.6%, BRS by 43.7% and BEI by 57.3%. None of the variables studied was altered over time in either control group. The increased cardiorespiratory fitness by exercise training was associated with an improved BRS function and a modification of the sympathovagal control of HRV towards a persistent increase in parasympathetic tone. These alterations may lead to a better cardiovascular prognosis in RT recipients.

  4. Cardiovascular outcome trials in type 2 diabetes and the sulphonylurea controversy: rationale for the active-comparator CAROLINA trial

    NARCIS (Netherlands)

    Rosenstock, Julio; Marx, Nikolaus; Kahn, Steven E.; Zinman, Bernard; Kastelein, John J.; Lachin, John M.; Bluhmki, Erich; Patel, Sanjay; Johansen, Odd-Erik; Woerle, Hans-Jürgen

    2013-01-01

    Sulphonylureas (SUs) are widely used glucose-lowering agents in type 2 diabetes mellitus (T2DM) with apparent declining efficacy over time. Concerns have been raised from observational retrospective studies on the cardiovascular (CV) safety of SUs but there are few long-term data on CV outcomes from

  5. Evaluation of Cardiovascular Morbidity in Nigerian Women after 3 ...

    African Journals Online (AJOL)

    elearning

    tion and use of Norplant implants in Indonesia. Studies in Family Planning 1998; 29: 291-9. 2. Zenger E, Shuhua Q, Huimin F. Introduction of. Norplant implants in four counties in China: Two year evaluation. Contraception 1995; 52: 349-55. 3. Ruminjo JK, Amatya RN, Dunson TR, Kruger. SL. Norplant implant acceptability ...

  6. Internet-delivered cognitive behavioural therapy for adults with mild to moderate depression and high cardiovascular disease risks: a randomised attention-controlled trial.

    Directory of Open Access Journals (Sweden)

    Nicholas Glozier

    Full Text Available BACKGROUND AND AIM: Mild to moderate depression is common in those with cardiovascular disease and undertreated. We aimed to evaluate the effectiveness of internet-delivered Cognitive Behaviour Therapy (iCBT on depressive symptom severity and adherence to medical advice and lifestyle interventions in adults with mild to moderate depression and high cardiovascular disease (CVD risks. METHODS: Randomised double-blind, 12 week attention-controlled trial comparing an iCBT programme (E-couch with an internet-delivered attention control health information package (HealthWatch, n = 282. The primary outcome was depression symptom level on the nine-item Patient Health Questionnaire (PHQ-9 (trial registration: ACTRN12610000085077. RESULTS: 487/562 (88% participants completed the endpoint assessment. 383/562 (70% were currently treated for cardiovascular disease and 314/562 (56% had at least one other comorbid condition. In ITT analysis of 562 participants iCBT produced a greater decline in the mean PHQ-9 score compared to the attention control of 1.06 (95% CI: 0.23-1.89 points, with differences between the two arms increasing over the intervention period (time by treatment effect interaction p = .012. There were also larger improvements in adherence (2.16 points; 95% CI: 0.33-3.99, reductions in anxiety (0.96 points; 95% CI: 0.19-1.73, and a greater proportion engaging in beneficial physical activity (Odds Ratio 1.91, 95%CI: 1.01-3.61 in the iCBT participants but no effect upon disability, or walking time/day. There were no withdrawals due to study related adverse events. CONCLUSIONS: In people with mild to moderate depression and high levels of CVD risk factors, a freely accessible iCBT programme (http://www.ecouch.anu.edu.au produced a small, but robust, improvement in depressive symptoms, adherence and some health behaviours. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12610000085077.

  7. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial.

    Science.gov (United States)

    Ramírez, Jorge H; Arce, Roger M; Contreras, Adolfo

    2011-02-16

    Periodontal disease (PD) is an infectious clinical entity characterized by the destruction of supporting tissues of the teeth as the result of a chronic inflammatory response in a susceptible host. It has been proposed that PD as subclinical infection may contribute to the etiology and to the pathogenesis of several systemic diseases including Atherosclerosis. A number of epidemiological studies link periodontal disease/edentulism as independent risk factor for acute myocardial infarction, peripheral vascular disease, and cerebrovascular disease. Moreover, new randomized controlled clinical trials have shown an improvement on cardiovascular surrogate markers (endothelial function, sICAM, hsPCR level, fibrinogen) after periodontal treatment. Nonetheless, such trials are still limited in terms of external validity, periodontal treatment strategies, CONSORT-based design and results consistency/extrapolation. The current study is designed to evaluate if periodontal treatment with scaling and root planning plus local delivered chlorhexidine improves endothelial function and other biomarkers of cardiovascular disease in subjects with moderate to severe periodontitis. This randomized, single-blind clinical trial will be performed at two health centers and will include two periodontal treatment strategies. After medical/periodontal screening, a baseline endothelium-dependent brachial artery flow-mediated dilatation (FMD) and other systemic surrogate markers will be obtained from all recruited subjects. Patients then will be randomized to receive either supragingival/subgingival plaque cleaning and calculus removal plus chlorhexidine (treatment group) or supragingival plaque removal only (control group). A second and third FMD will be obtained after 24 hours and 12 weeks in both treatment arms. Each group will consist of 49 patients (n = 98) and all patients will be followed-up for secondary outcomes and will be monitored through a coordinating center. The primary outcomes

  8. Publication Speed, Reporting Metrics, and Citation Impact of Cardiovascular Trials Supported by the National Heart, Lung, and Blood Institute

    Science.gov (United States)

    Gordon, David; Cooper-Arnold, Katharine; Lauer, Michael

    2015-01-01

    Background We previously demonstrated that cardiovascular (CV) trials funded by the National Heart, Lung, and Blood Institute (NHLBI) were more likely to be published in a timely manner and receive high raw citation counts if they focused on clinical endpoints. We did not examine the metrics of trial reports, and our citation measures were limited by failure to account for topic-related citation behaviors. Methods and Results Of 244 CV trials completed between 2000 and 2011, we identified 184 whose main results were published by August 20, 2014. One investigator who was blinded to rapidity of publication and citation data read each publication and characterized it according to modified Delphi criteria. There were 46 trials (25%) that had Delphi scores of 8 or 9 (of a possible 9); these trials published faster (median time from trial completion to publication, 12.6 [interquartile range {IQR}, 6.7 to 23.3] vs. 21.8 [IQR, 12.1 to 34.9] months; Pcitation impact (median citation percentile for topic and date of publication, with 0 best and 100 worst, 1.92 [IQR, 0.64 to 7.83] vs. 8.41 [IQR, 1.80 to 24.75]; P=0.002). By random forest regression, we found that the 3 most important predictors of normalized citation percentile values were total costs, intention-to-treat analyses (as a modified Delphi quality measure), and focus on clinical (not surrogate) endpoints. Conclusions NHLBI CV trials were more likely to publish results quickly and yield higher topic-normalized citation impact if they reported results according to well-defined metrics, along with focus on clinical endpoints. PMID:26231845

  9. Publication Speed, Reporting Metrics, and Citation Impact of Cardiovascular Trials Supported by the National Heart, Lung, and Blood Institute.

    Science.gov (United States)

    Gordon, David; Cooper-Arnold, Katharine; Lauer, Michael

    2015-07-31

    We previously demonstrated that cardiovascular (CV) trials funded by the National Heart, Lung, and Blood Institute (NHLBI) were more likely to be published in a timely manner and receive high raw citation counts if they focused on clinical endpoints. We did not examine the metrics of trial reports, and our citation measures were limited by failure to account for topic-related citation behaviors. Of 244 CV trials completed between 2000 and 2011, we identified 184 whose main results were published by August 20, 2014. One investigator who was blinded to rapidity of publication and citation data read each publication and characterized it according to modified Delphi criteria. There were 46 trials (25%) that had Delphi scores of 8 or 9 (of a possible 9); these trials published faster (median time from trial completion to publication, 12.6 [interquartile range {IQR}, 6.7 to 23.3] vs. 21.8 [IQR, 12.1 to 34.9] months; Pcitation impact (median citation percentile for topic and date of publication, with 0 best and 100 worst, 1.92 [IQR, 0.64 to 7.83] vs. 8.41 [IQR, 1.80 to 24.75]; P=0.002). By random forest regression, we found that the 3 most important predictors of normalized citation percentile values were total costs, intention-to-treat analyses (as a modified Delphi quality measure), and focus on clinical (not surrogate) endpoints. NHLBI CV trials were more likely to publish results quickly and yield higher topic-normalized citation impact if they reported results according to well-defined metrics, along with focus on clinical endpoints. © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

  10. Albuminuria and cardiovascular events in patients with acute coronary syndromes: Results from the TRACER trial.

    Science.gov (United States)

    Åkerblom, Axel; Clare, Robert M; Lokhnygina, Yuliya; Wallentin, Lars; Held, Claes; Van de Werf, Frans; Moliterno, David J; Patel, Uptal D; Leonardi, Sergio; Armstrong, Paul W; Harrington, Robert A; White, Harvey D; Aylward, Philip E; Mahaffey, Kenneth W; Tricoci, Pierluigi

    2016-08-01

    Albuminuria is associated with cardiovascular (CV) outcomes. We evaluated albuminuria, alone and in combination with estimated glomerular filtration rate (eGFR), as a predictor of mortality and CV morbidity in 12,944 patients with non-ST-segment elevation acute coronary syndromes. Baseline serum creatinine and urinary dipsticks were obtained, with albuminuria stratified into no/trace albuminuria, microalbuminuria (≥30 but albuminuria and creatinine values were available in 9473 patients (73.2%). More patients with macroalbuminuria, versus no/trace albuminuria, had diabetes (66% vs 27%) or hypertension (86% vs 68%). Rates for CV death and overall mortality per strata were 3.1% and 4.8% (no/trace albuminuria); 5.8% and 9.0% (microalbuminuria); and 7.7% and 12.6% (macroalbuminuria) at 2 years of follow-up. Corresponding rates for CV death or MI were 12.2%, 16.9%, and 23.5%, respectively. Observed acute kidney injury rates were 0.6%, 1.2%, and 2.9% (n = 79), respectively. Adjusted HRs for macroalbuminuria on CV mortality were 1.65 (95% CI 1.15-2.37), and after adjustment with eGFR, 1.37 (95% CI 0.93-2.01). Corresponding HRs for overall mortality were 1.82 (95% CI 1.37-2.42) and 1.47 (95% CI 1.08-1.98). High-risk patients with non-ST-segment elevation acute coronary syndromes and albuminuria have increased morbidity and increased overall mortality independent of eGFR. Copyright © 2016 Elsevier Inc. All rights reserved.

  11. How Does Empagliflozin Reduce Cardiovascular Mortality? Insights From a Mediation Analysis of the EMPA-REG OUTCOME Trial.

    Science.gov (United States)

    Inzucchi, Silvio E; Zinman, Bernard; Fitchett, David; Wanner, Christoph; Ferrannini, Ele; Schumacher, Martin; Schmoor, Claudia; Ohneberg, Kristin; Johansen, Odd Erik; George, Jyothis T; Hantel, Stefan; Bluhmki, Erich; Lachin, John M

    2018-02-01

    In the BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) trial involving 7,020 patients with type 2 diabetes and established cardiovascular (CV) disease, empagliflozin given in addition to standard of care reduced the risk of CV death by 38% versus placebo (hazard ratio [HR] 0.62 [95% CI 0.49, 0.77]). This exploratory mediation analysis assesses the extent to which treatment group differences in covariates during the trial contributed to CV death risk reduction with empagliflozin. Effects of potential mediators, identified post hoc, on the HR for CV death with empagliflozin versus placebo were analyzed by Cox regression models, with treatment group adjusted for the baseline value of the variable and its change from baseline or updated mean (i.e., considering all prior values), each as a time-dependent covariate. HRs were compared with a model without adjustment for covariates. Multivariable analyses also were performed. Changes in hematocrit and hemoglobin mediated 51.8% and 48.9%, respectively, of the effect of empagliflozin versus placebo on the risk of CV death on the basis of changes from baseline, with similar results in analyses on the basis of updated means. Smaller mediation effects (maximum 29.3%) were observed for uric acid, fasting plasma glucose, and HbA 1c . In multivariable models, which incorporated effects of empagliflozin on hematocrit, fasting glucose, uric acid, and urine albumin:creatinine ratio, the combined changes from baseline provided 85.2% mediation, whereas updated mean analyses provided 94.6% mediation of the effect of empagliflozin on CV death. In this exploratory analysis from the EMPA-REG OUTCOME trial, changes in markers of plasma volume were the most important mediators of the reduction in risk of CV death with empagliflozin versus placebo. © 2017 by the American Diabetes Association.

  12. Cardiovascular safety of exenatide BID: an integrated analysis from controlled clinical trials in participants with type 2 diabetes

    Directory of Open Access Journals (Sweden)

    Yushmanova Irina

    2011-03-01

    Full Text Available Abstract It is important for patients that treatments for diabetes not increase cardiovascular (CV risk. The objective of this analysis was to examine retrospectively the CV safety of exenatide BID, a GLP-1 receptor agonist approved for treating hyperglycemia in patients with type 2 diabetes not adequately controlled with diet and exercise. Individual participant data was pooled to assess the relative risk (RR of CV events with exenatide BID versus a pooled comparator (PC group treated with either placebo or insulin from 12 controlled, randomized, clinical trials ranging from 12-52 weeks. Mean baseline values for HbA1c (8.33-8.38%, BMI (31.3-31.5 kg/m2, and duration of diabetes (8 y were similar between groups. Trials included patients with histories of microvascular and/or macrovascular disease. Customized primary major adverse CV events (MACE included stroke, myocardial infarction, cardiac mortality, acute coronary syndrome, and revascularization procedures. The Primary MACE RR (0.7; 95% CI 0.38, 1.31, calculated by the Mantel-Haenszel method (stratified by study, suggested that exenatide use (vs. PC did not increase CV risk; this result was consistent across multiple analytic methods. Because the trials were not designed to assess CV outcomes, events were identified retrospectively from a list of preferred terms by physicians blinded to treatment. Other limitations included the low number of CV events, the short duration of trials (≤1 y, and a single active comparator (insulin. The results of these analyses are consistent with those of a recent retrospective analysis of a large insurance database that found that patients treated with exenatide twice daily were less likely to have a CV event than were patients treated with other glucose-lowering therapies. Keywords: GLP-1 receptor agonist, diabetes, cardiovascular safety

  13. Pseudoxanthoma elasticum: case report with arterial stiffness evaluated by a research cardiovascular profiling system.

    Science.gov (United States)

    Sabán-Ruiz, Jose; Fabregate Fuente, Rosa; Sánchez-Largo Uceda, Elena; Fabregate Fuente, Martin

    2010-01-01

    Pseudoxanthoma elasticum (PXE) is an inherited systemic disorder characterized by calcification of elastic tissue, affecting the skin, the eyes and vascular system. The aim of our study was to specify the cardiovascular changes in a case of pseudoxanthoma elasticum by a non-invasive haemodynamic evaluation. We present a 50-year-old woman with a clinical diagnosis of pseudoxanthoma elasticum. Except for hypertension, treated over the past four years, there was no other modifiable cardiovascular risk factor. The patient had a familiar history of early cardiovascular death. In the physical examination, typical skin lesions were present and also an angioid streak of the retina. The patient and a control group were evaluated by the CR-2000 Research Cardiovascular Profiling System. A lower elasticity in large arteries (p = 0.006), a higher cardiac output (p = 0.006) and a higher total vascular impedance (p = 0.006) were observed with respect to the control group. There was no difference comparing this value with an elderly control group. We suggest that patients with PXE present vascular changes comparable with elderly patients and that these differences can not be explained by hypertension.

  14. Design and baseline characteristics of the PerfectFit study: a multicenter cluster-randomized trial of a lifestyle intervention in employees with increased cardiovascular risk.

    Science.gov (United States)

    Kouwenhoven-Pasmooij, Tessa A; Djikanovic, Bosiljka; Robroek, Suzan J W; Helmhout, Pieter; Burdorf, Alex; Hunink, M G Myriam

    2015-07-28

    , physical activity, stress management) and body mass index. Furthermore, a process evaluation and an economic analysis will be performed. Additional coaching using MI is expected to be a key factor for success of the web-based HRA in employees with increased cardiovascular risk. This "blended care"-approach may be an essential strategy for effective health promotion activities. Dutch Trial Register by registration number NTR4894 , 14/11/2014.

  15. WHAT CAN WE EXPECT USING ACE INHIBITOR RAMIPRIL IN PERSONS WITH HIGH CARDIOVASCULAR RISK AND EARLY DISORDERS OF CARBOHYDRATE METABOLISM? LESSONS OF DREAM TRIAL

    OpenAIRE

    M. N. Mamedov; M. B. Stroeva

    2008-01-01

    Primary prevention of diabetes in persons with high cardiovascular risk is an actual problem. Results of DREAM trial are discussed. Influence of ACE inhibitor, ramipril, on risk of diabetes onset in patients with pre-diabetes and low cardiovascular risk is focused. Metabolic effects of other groups of antihypertensive drugs and their ability to prevent diabetes onset are compared. Ramipril three years therapy resulted in normalization in glucose level but did not have effect on frequency of d...

  16. A randomized controlled trial of an exercise intervention targeting cardiovascular and metabolic risk factors for prostate cancer patients from the RADAR trial

    International Nuclear Information System (INIS)

    Galvão, Daniel A; Spry, Nigel; Taaffe, Dennis R; Denham, James; Joseph, David; Lamb, David S; Levin, Greg; Duchesne, Gillian; Newton, Robert U

    2009-01-01

    Androgen deprivation therapy leads to a number of adverse effects including deterioration of the musculoskeletal system and increased risk factors for cardiovascular and metabolic complications. The purpose of this study is to determine the effects, efficacy, retention and compliance of a physical exercise intervention in a large established cohort of prostate cancer patients from the Randomised Androgen Deprivation and Radiotherapy (RADAR) study. Specifically, we aim to compare short- and long-term effects of a prostate cancer-specific supervised exercise program to a standard public health physical activity strategy utilizing printed resources on cardiovascular and metabolic risk factors. Our primary outcomes are cardiorespiratory capacity, abdominal obesity, and lipid and glycemic control, while secondary outcomes include self-reported physical activity, quality of life and psychological distress. Multi-site randomized controlled trial of 370 men from the RADAR study cohort undergoing treatment or previously treated for prostate cancer involving androgen deprivation therapy in the cities of Perth and Newcastle (Australia), and Wellington (New Zealand). Participants will be randomized to (1) supervised resistance/aerobic exercise or (2) printed material comprising general physical activity recommendations. Participants will then undergo progressive training for 6 months. Measurements for primary and secondary endpoints will take place at baseline, 6 months (end of intervention), and at 6 months follow-up. This study uses a large existent cohort of patients and will generate valuable information as to the continuing effects of exercise specifically targeting cardiovascular function and disease risk, insulin metabolism, abdominal obesity, physical function, quality of life and psychological distress. We expect dissemination of the knowledge gained from this project to reduce risk factors for the development of co-morbid diseases commonly associated with androgen

  17. Tolerability of sibutramine during a 6-week treatment period in high-risk patients with cardiovascular disease and/or diabetes: a preliminary analysis of the Sibutramine Cardiovascular Outcomes (SCOUT) Trial

    DEFF Research Database (Denmark)

    Maggioni, A.P.; Caterson, I.; Coutinho, W.

    2008-01-01

    Uncertainties about the cardiovascular safety of sibutramine led to the SCOUT trial that is investigating sibutramine plus weight management in high-risk, overweight/obese patients. A 6-week lead-in period during which all patients received sibutramine permitted an initial assessment...

  18. 75 FR 47819 - Workshop on Optimizing Clinical Trial Design for the Development of Pediatric Cardiovascular Devices

    Science.gov (United States)

    2010-08-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001...: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration... (AAP), the American College of Cardiology (ACC), and the Society for Cardiovascular Angiography and...

  19. Cardiovascular disease after treatment for Hodgkin's lymphoma: an analysis of nine collaborative EORTC-LYSA trials

    DEFF Research Database (Denmark)

    Maraldo, Maja V.; Giusti, Francesco; Vogelius, Ivan R.

    2015-01-01

    events. INTERPRETATION: Quantification of the increased cardiovascular risk with specific doses of radiation and anthracycline exposure will enable a quantitative assessment of the optimum combination of systemic therapy and radiation, which will help clinicians to balance the risks and benefits...... of different regimens for individual patients. FUNDING: Rigshospitalet Research Committee, the EORTC Cancer Research Fund, and the Sally Snowman Survivorship Fellowship....

  20. Cardiovascular effects of B-vitamins and/or N-3 fatty acids: the SU.FOL.OM3 trial.

    Science.gov (United States)

    Blacher, Jacques; Czernichow, Sébastien; Paillard, François; Ducimetiere, Pierre; Hercberg, Serge; Galan, Pilar

    2013-07-31

    Mechanisms involved in coronary stenosis evolution are different than those involved in clinical events. Because of differential vascular effects, N-3 polyunsatured fatty acids (PUFA) and B vitamins could have differential effects on different types of cardiovascular clinical events in high-risk patients. We analyzed the effects of n-3 PUFA and of B vitamins on both coronary revascularization and on hard coronary events risks in a subgroup of the SU.FOL.OM3 trial, a randomized, double-blind, placebo-controlled secondary prevention trial. Data were analyzed according to the intention-to-treat principle, with the use of Cox proportional-hazards models. After a mean follow-up of 4.2 ± 1.0 years among the 1,863 participants with coronary heart disease, 163 coronary revascularizations were performed, and 95 patients experienced a hard coronary event. Neither treatment with n-3 PUFA, nor treatment with B vitamins was associated with any significant effect on the occurrence of hard coronary events. Allocation to n-3 PUFA was not associated with any significant effect on coronary revascularization. However, treatment with B vitamins was associated with a statistically significant 52% increase in the risk of coronary revascularization (multivariate HR: 1.52; 95% CI: [1.11-2.10]; p=0.01). Neither n-3 PUFA, nor B vitamins reduced the rates of hard coronary events and of coronary revascularization. Furthermore, B vitamins significantly increased the rate of coronary revascularization. Consistent with the findings of previous trials, our results do not support the routine use of dietary supplements containing n-3 PUFA and argue against using dietary supplements containing B-vitamins in coronary patients in secondary cardiovascular prevention. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  1. Total Cardiovascular Events Analysis of the EXAMINE Trial in Patients with Type 2 Diabetes and Recent Acute Coronary Syndrome.

    Science.gov (United States)

    Cavender, Matthew A; White, William B; Liu, Yuyin; Massaro, Joseph M; Bergenstal, Richard M; Mehta, Cyrus R; Zannad, Faiez; Heller, Simon; Cushman, William C; Cannon, Christopher P

    2018-04-13

    Alogliptin, a dipeptidyl-peptidase 4 inhibitor, is approved for the treatment of patients with type 2 diabetes. EXAMINE was a randomized-controlled clinical trial designed to demonstrate the cardiovascular safety of alogliptin. In the trial, 5380 patients with established T2DM who had a recent ACS event (between 15-90 days) were randomized to treatment with either alogliptin or placebo. To better understand and describe the cardiovascular (CV) safety of alogliptin, we analyzed data from the EXAMINE randomized clinical trial to determine whether treatment with alogliptin affected recurrent and total CV events. Poisson regression analysis was performed to compare the total number of occurrences of CV death, MI, stroke, unstable angina, and coronary revascularization between all patients randomized to alogliptin versus placebo groups. Patients with recurrent CV events were older and more likely to have renal disease and history of heart failure. There were 1100 first CV events and an additional 666 recurrent events over a median of 18 months of follow-up. There were no significant differences with regard to the total number of events in patients treated with alogliptin (n=873) or placebo (n=893; p=0.52). Furthermore, there were no differences in the types of events seen in patients treated with alogliptin or placebo. Alogliptin did not increase the risk of either first or recurrent CV events when compared to placebo in patients with type 2 diabetes and recent ACS. These data support the CV safety of alogliptin in patients who are at increased risk of future CV events. This article is protected by copyright. All rights reserved.

  2. Interruption of antiretroviral therapy and risk of cardiovascular disease in persons with HIV-1 infection: exploratory analyses from the SMART trial

    DEFF Research Database (Denmark)

    Phillips, Andrew N; Carr, Andrew; Neuhaus, Jacquie

    2008-01-01

    BACKGROUND: The SMART trial found a raised risk of cardiovascular disease (CVD) events in patients undergoing CD4+ T cell-count guided intermittent antiretroviral therapy (ART) compared with patients on continuous ART. Exploratory analyses were performed to better understand the reasons for this ......BACKGROUND: The SMART trial found a raised risk of cardiovascular disease (CVD) events in patients undergoing CD4+ T cell-count guided intermittent antiretroviral therapy (ART) compared with patients on continuous ART. Exploratory analyses were performed to better understand the reasons...

  3. Effects of total dietary polyphenols on plasma nitric oxide and blood pressure in a high cardiovascular risk cohort. The PREDIMED randomized trial.

    Science.gov (United States)

    Medina-Remón, A; Tresserra-Rimbau, A; Pons, A; Tur, J A; Martorell, M; Ros, E; Buil-Cosiales, P; Sacanella, E; Covas, M I; Corella, D; Salas-Salvadó, J; Gómez-Gracia, E; Ruiz-Gutiérrez, V; Ortega-Calvo, M; García-Valdueza, M; Arós, F; Saez, G T; Serra-Majem, L; Pinto, X; Vinyoles, E; Estruch, R; Lamuela-Raventos, R M

    2015-01-01

    Hypertension is one of the main cardiovascular risk factors in the elderly. The aims of this work were to evaluate if a one-year intervention with two Mediterranean diets (Med-diet) could decrease blood pressure (BP) due to a high polyphenol consumption, and if the decrease in BP was mediated by plasma nitric oxide (NO) production. An intervention substudy of 200 participants at high cardiovascular risk was carried out within the PREDIMED trial. They were randomly assigned to a low-fat control diet or to two Med-diets, one supplemented with extra virgin olive oil (Med-EVOO) and the other with nuts (Med-nuts). Anthropometrics and clinical parameters were measured at baseline and after one year of intervention, as well as BP, plasma NO and total polyphenol excretion (TPE) in urine samples. Systolic and diastolic BP decreased significantly after a one-year dietary intervention with Med-EVOO and Med-nuts. These changes were associated with a significant increase in TPE and plasma NO. Additionally, a significant positive correlation was observed between changes in urinary TPE, a biomarker of TP intake, and in plasma NO (Beta = 4.84; 95% CI: 0.57-9.10). TPE in spot urine sample was positively correlated with plasma NO in Med-diets supplemented with either EVOO or nuts. The statistically significant increases in plasma NO were associated with a reduction in systolic and diastolic BP levels, adding to the growing evidence that polyphenols might protect the cardiovascular system by improving the endothelial function and enhancing endothelial synthesis of NO. Copyright © 2014 Elsevier B.V. All rights reserved.

  4. Mediterranean Diet and Cardiovascular Disease: A Critical Evaluation of A Priori Dietary Indexes

    Science.gov (United States)

    D’Alessandro, Annunziata; De Pergola, Giovanni

    2015-01-01

    The aim of this paper is to analyze the a priori dietary indexes used in the studies that have evaluated the role of the Mediterranean Diet in influencing the risk of developing cardiovascular disease. All the studies show that this dietary pattern protects against cardiovascular disease, but studies show quite different effects on specific conditions such as coronary heart disease or cerebrovascular disease. A priori dietary indexes used to measure dietary exposure imply quantitative and/or qualitative divergences from the traditional Mediterranean Diet of the early 1960s, and, therefore, it is very difficult to compare the results of different studies. Based on real cultural heritage and traditions, we believe that the a priori indexes used to evaluate adherence to the Mediterranean Diet should consider classifying whole grains and refined grains, olive oil and monounsaturated fats, and wine and alcohol differently. PMID:26389950

  5. Mediterranean Diet and Cardiovascular Disease: A Critical Evaluation of A Priori Dietary Indexes

    Directory of Open Access Journals (Sweden)

    Annunziata D'Alessandro

    2015-09-01

    Full Text Available The aim of this paper is to analyze the a priori dietary indexes used in the studies that have evaluated the role of the Mediterranean Diet in influencing the risk of developing cardiovascular disease. All the studies show that this dietary pattern protects against cardiovascular disease, but studies show quite different effects on specific conditions such as coronary heart disease or cerebrovascular disease. A priori dietary indexes used to measure dietary exposure imply quantitative and/or qualitative divergences from the traditional Mediterranean Diet of the early 1960s, and, therefore, it is very difficult to compare the results of different studies. Based on real cultural heritage and traditions, we believe that the a priori indexes used to evaluate adherence to the Mediterranean Diet should consider classifying whole grains and refined grains, olive oil and monounsaturated fats, and wine and alcohol differently.

  6. Evaluation of cardiovascular anomalies in patients with asymptomatic turner syndrome using multidetector computed tomography.

    Science.gov (United States)

    Lee, Sun Hee; Jung, Ji Mi; Song, Min Seob; Choi, Seok jin; Chung, Woo Yeong

    2013-08-01

    Turner syndrome is well known to be associated with significant cardiovascular abnormalities. This paper studied the incidence of cardiovascular abnormalities in asymptomatic adolescent patients with Turner syndrome using multidetector computed tomography (MDCT) instead of echocardiography. Twenty subjects diagnosed with Turner syndrome who had no cardiac symptoms were included. Blood pressure and electrocardiography (ECG) was checked. Cardiovascular abnormalities were checked by MDCT. According to the ECG results, 11 had a prolonged QTc interval, 5 had a posterior fascicular block, 3 had a ventricular conduction disorder. MDCT revealed vascular abnormalities in 13 patients (65%). Three patients had an aberrant right subclavian artery, 2 had dilatation of left subclavian artery, and others had an aortic root dilatation, aortic diverticulum, and abnormal left vertebral artery. As for venous abnormalities, 3 patients had partial anomalous pulmonary venous return and 2 had a persistent left superior vena cava. This study found cardiovascular abnormalities in 65% of asymptomatic Turner syndrome patients using MDCT. Even though, there are no cardiac symptoms in Turner syndrome patients, a complete evaluation of the heart with echocardiography or MDCT at transition period to adults must be performed.

  7. Are potentially clinically meaningful benefits misinterpreted in cardiovascular randomized trials? A systematic examination of statistical significance, clinical significance, and authors' conclusions.

    Science.gov (United States)

    Allan, G Michael; Finley, Caitlin R; McCormack, James; Kumar, Vivek; Kwong, Simon; Braschi, Emelie; Korownyk, Christina; Kolber, Michael R; Lindblad, Adriennne J; Babenko, Oksana; Garrison, Scott

    2017-03-20

    While journals and reporting guidelines recommend the presentation of confidence intervals, many authors adhere strictly to statistically significant testing. Our objective was to determine what proportions of not statistically significant (NSS) cardiovascular trials include potentially clinically meaningful effects in primary outcomes and if these are associated with authors' conclusions. Cardiovascular studies published in six high-impact journals between 1 January 2010 and 31 December 2014 were identified via PubMed. Two independent reviewers selected trials with major adverse cardiovascular events (stroke, myocardial infarction, or cardiovascular death) as primary outcomes and extracted data on trial characteristics, quality, and primary outcome. Potentially clinically meaningful effects were defined broadly as a relative risk point estimate ≤0.94 (based on the effects of ezetimibe) and/or a lower confidence interval ≤0.75 (based on the effects of statins). We identified 127 randomized trial comparisons from 3200 articles. The primary outcomes were statistically significant (SS) favoring treatment in 21% (27/127), NSS in 72% (92/127), and SS favoring control in 6% (8/127). In 61% of NSS trials (56/92), the point estimate and/or lower confidence interval included potentially meaningful effects. Both point estimate and confidence interval included potentially meaningful effects in 67% of trials (12/18) in which authors' concluded that treatment was superior, in 28% (16/58) with a neutral conclusion, and in 6% (1/16) in which authors' concluded that control was superior. In a sensitivity analysis, 26% of NSS trials would include potential meaningful effects with relative risk thresholds of point estimate ≤0.85 and/or a lower confidence interval ≤0.65. Point estimates and/or confidence intervals included potentially clinically meaningful effects in up to 61% of NSS cardiovascular trials. Authors' conclusions often reflect potentially meaningful results of

  8. Evaluative threat and ambulatory blood pressure: cardiovascular effects of social stress in daily experience.

    Science.gov (United States)

    Smith, Timothy W; Birmingham, Wendy; Uchino, Bert N

    2012-11-01

    Physiological effects of social evaluation are central in models of psychosocial influences on physical health. Experimental manipulations of evaluative threat evoke substantial cardiovascular and neuroendocrine responses in laboratory studies, but only preliminary evidence is available regarding naturally occurring evaluative threats in daily life. In such nonexperimental ambulatory studies, it is essential to distinguish effects of evaluative threat from related constructs known to alter stress, such as ability perceptions and concerns about appearance. 94 married, working couples (mean age 29.2 years) completed a 1-day (8 a.m. to 10 p.m.) ambulatory blood pressure protocol with random interval-contingent measurements using a Suntech monitor and Palm Pilot-based measures of control variables and momentary experiences of social-evaluative threat, concerns about appearance, and perceived ability. In hierarchical analyses for couples and multiple measurement occasions (Proc Mixed; SAS) and controlling individual differences (BMI, age, income) and potential confounds (e.g., posture, activity), higher reports of social-evaluative threat were associated with higher concurrent systolic (estimate = .87, SE = .34) and diastolic blood pressure (estimate = 1.06; SE = .26), both p social-evaluative threat remained significant when perceived ability and appearance concerns were controlled. Naturally occurring social-evaluative threat during daily activity is associated with increased systolic and diastolic blood pressure. Given associations between ambulatory blood pressure and risk of cardiovascular disease, the findings support conceptual models of threats to the social self as a potentially important influence on physical health.

  9. Cardiovascular radiology

    International Nuclear Information System (INIS)

    VanAman, M.; Mueller, C.F.

    1985-01-01

    Soon after Roentgen documented the uses of x-rays in 1895, fluoroscopic and film evaluation of the heart began. Even today the chest roentgenogram remains one of the first and most frequently used studies for the evaluation of the normal and abnormal heart and great vessels. This chapter gives an overview of plain film evaluation of the cardiovascular system and follow up with comments on the newer imaging modalities of computed tomography, and digital subtraction angiography, in the cardiovascular disease workup. The authors present an evaluation of plain films of the chest, which remains their most cost effective, available, simple, and reliable initial screening tool in the evaluation of cardiovascular disease

  10. Influence of Acute Multispecies and Multistrain Probiotic Supplementation on Cardiovascular Function and Reactivity to Psychological Stress in Young Adults: A Double-Blind, Randomized, Placebo-Controlled Trial.

    Science.gov (United States)

    Möller, Clara M; Olsa, Eamon J A; Ginty, Annie T; Rapelje, Alyssa L; Tindall, Christina L; Holesh, Laura A; Petersen, Karen L; Conklin, Sarah M

    2017-10-01

    The potential influence of probiotic supplementation on cardiovascular health and stress responsivity remains largely unexplored. Some evidence suggests the possibility that probiotics may influence blood pressure. A separate body of research suggests that exaggerated cardiovascular reactions to acute psychological stress in the laboratory predict cardiovascular morbidity and mortality. The current investigation explored the effect of acute probiotic use on (1) resting cardiovascular measures in healthy young adults and (2) cardiovascular and psychological reactions to an acute psychological stressor in the laboratory. Participants (N = 105, M [SD] age = 20.17 [1.26], 84.8% white) completed a 2-week, double-blind, and placebo-controlled trial of a multispecies and multistrain probiotic. Exclusion criteria included previous probiotic use, diagnosed gastrointestinal disorder, and/or current antibiotic use. At visits 1 and 2, participants completed the Paced Auditory Serial Addition Test, a widely used psychological stress task. Participants were randomly assigned to a probiotic blend or matched placebo. Compared with placebo, 2-week probiotic supplementation did not affect resting measures of cardiovascular function, cardiovascular responses during or recovery from stress, or psychological reactions to acute psychological stress. Contrary to expectations, short-term use of a probiotic supplement in healthy participants did not influence measures of cardiovascular function or responsivity to psychological stress. Future research is needed to determine species- and strain-specific effects of probiotics in healthy participants with various degrees of stress responsiveness, as well as in diseased populations.

  11. Primary prevention of cardiovascular events with low-dose aspirin and vitamin E in type 2 diabetic patients: results of the Primary Prevention Project (PPP) trial.

    Science.gov (United States)

    Sacco, Michele; Pellegrini, Fabio; Roncaglioni, Maria C; Avanzini, Fausto; Tognoni, Gianni; Nicolucci, Antonio

    2003-12-01

    We investigated in general practice the efficacy of antiplatelets and antioxidants in primary prevention of cardiovascular events in people with type 2 diabetes. The Primary Prevention Project (PPP) is a randomized, open trial with a two-by-two factorial design aimed to investigate low-dose aspirin (100 mg/day) and vitamin E (300 mg/day) in the prevention of cardiovascular events in patients with one or more cardiovascular risk factors. The primary end point was a composite end point of cardiovascular death, stroke, or myocardial infarction. A total of 1,031 people with diabetes in the PPP, aged >/=50 years, without a previous cardiovascular event were enrolled by 316 general practitioners and 14 diabetes outpatient clinics. The PPP trial was prematurely stopped (after a median of 3.7 years) by the independent data safety and monitoring board because of a consistent benefit of aspirin compared with the control group in a population of 4,495 patients with one or more major cardiovascular risk factors. In diabetic patients, aspirin treatment was associated with a nonsignificant reduction in the main end point (relative risk [RR] = 0.90, 95% CI 0.50-1.62) and in total cardiovascular events (0.89, 0.62-1.26) and with a nonsignificant increase in cardiovascular deaths (1.23, 0.69-2.19). In nondiabetic subjects, RRs for the main end point, total cardiovascular events, and cardiovascular deaths were 0.59 (0.37-0.94), 0.69 (0.53-0.90), and 0.32 (0.14-0.72), respectively. No significant reduction in any of the end points considered could be found with vitamin E in either diabetic or nondiabetic subjects. Our data suggest a lower effect of primary prevention of cardiovascular disease (CVD) with low-dose aspirin in diabetic patients as opposed to subjects with other cardiovascular risk factors. If confirmed, these findings might indicate that the antiplatelet effects of aspirin in diabetic patients are overwhelmed by aspirin-insensitive mechanisms of platelet activation and

  12. Weight and blood pressure response to weight management and sibutramine in diabetic and non-diabetic high-risk patients: an analysis from the 6-week lead-in period of the sibutramine cardiovascular outcomes (SCOUT) trial

    DEFF Research Database (Denmark)

    Van Gaal, L F; Caterson, I D; Coutinho, W

    2010-01-01

    To assess treatment responses to sibutramine and weight management in diabetic patients during the lead-in period of the Sibutramine Cardiovascular OUTcomes (SCOUT) trial.......To assess treatment responses to sibutramine and weight management in diabetic patients during the lead-in period of the Sibutramine Cardiovascular OUTcomes (SCOUT) trial....

  13. Orange juice-derived flavanone and phenolic metabolites do not acutely affect cardiovascular risk biomarkers: a randomized, placebo-controlled, crossover trial in men at moderate risk of cardiovascular disease.

    Science.gov (United States)

    Schär, Manuel Y; Curtis, Peter J; Hazim, Sara; Ostertag, Luisa M; Kay, Colin D; Potter, John F; Cassidy, Aedín

    2015-05-01

    Epidemiologic data suggest inverse associations between citrus flavanone intake and cardiovascular disease (CVD) risk. However, insufficient randomized controlled trial data limit our understanding of the mechanisms by which flavanones and their metabolites potentially reduce cardiovascular risk factors. We examined the effects of orange juice or a dose-matched hesperidin supplement on plasma concentrations of established and novel flavanone metabolites and their effects on cardiovascular risk biomarkers in men at moderate CVD risk. In an acute, randomized, placebo-controlled crossover trial, 16 fasted participants (aged 51-69 y) received orange juice or a hesperidin supplement (both providing 320 mg hesperidin) or control (all matched for sugar and vitamin C content). At baseline and 5 h postintake, endothelial function (primary outcome), blood pressure, arterial stiffness, cardiac autonomic function, platelet activation, and NADPH oxidase gene expression and plasma flavanone metabolites were assessed. Before each intervention, a diet low in flavonoids, nitrate/nitrite, alcohol, and caffeine was followed, and a standardized low-flavonoid evening meal was consumed. Orange juice intake significantly elevated mean ± SEM plasma concentrations of 8 flavanone (1.75 ± 0.35 μmol/L, P orange juice matrix. After single-dose flavanone intake within orange juice, circulating flavanone and phenolic metabolites collectively reached a concentration of 15.20 ± 2.15 μmol/L, but no effects were observed on cardiovascular risk biomarkers. Longer-duration randomized controlled trials are required to examine previous associations between higher flavanone intakes and improved cardiovascular health and to ascertain the relative importance of food matrix and flavanone-derived phenolic metabolites. This trial was registered at clinicaltrials.gov as NCT01530893.

  14. Evaluation of a multicomponent workplace health promotion program conducted in Japan for improving employees' cardiovascular disease risk factors.

    Science.gov (United States)

    Muto, T; Yamauchi, K

    2001-12-01

    The long-term effectiveness of multicomponent worksite health promotion programs targeting cardiovascular disease risk factors remains unclear in Japan. This study was conducted to evaluate the effectiveness of such a health promotion program consisting of a main program provided over 4 days and a follow-up program provided over 1 year. The subjects of this randomized controlled trial were male employees working for a building maintenance company in Japan. The intervention group (n = 152) and the control group (n = 150) consisted of employees having abnormal findings in at least one of the following items at baseline health examination: body mass index (BMI), systolic (SBP) or diastolic blood pressure, total cholesterol, HDL cholesterol, triglycerides, and fasting blood glucose. Evaluation was conducted at 18 months after the main program. BMI, SBP, total cholesterol, and triglycerides improved significantly in the intervention group compared with the control group (P < 0.05). When comparisons were limited to those who showed abnormality at baseline, BMI, total cholesterol, and triglycerides improved significantly in the intervention group (P < 0.05). The multicomponent health promotion program provided to employees was shown to be effective in improving obesity, high blood pressure, and hyperlipidemia when evaluated 18 months after the main intervention program. Copyright 2001 American Health Foundation and Elsevier Science.

  15. Analysis of stroke in ATHENA: a placebo-controlled, double-blind, parallel-arm trial to assess the efficacy of dronedarone 400 mg BID for the prevention of cardiovascular hospitalization or death from any cause in patients with atrial fibrillation/atrial flutter

    DEFF Research Database (Denmark)

    Connolly, Stuart J; Crijns, Harry J G M; Torp-Pedersen, Christian

    2009-01-01

    , on stroke has been evaluated in a randomized, double-blind clinical trial, ATHENA (A placebo-controlled, double-blind, parallel-arm Trial to assess the efficacy of dronedarone 400 mg BID for the prevention of cardiovascular Hospitalization or death from any cause in patiENts with Atrial fibrillation....../atrial flutter). METHODS AND RESULTS: Patients with persistent or paroxysmal atrial fibrillation and at least 1 risk factor for cardiovascular hospitalization were randomized to receive dronedarone (400 mg BID) or double-blind matching placebo and followed up for a minimum of 1 year to a common termination at 30...

  16. The Mediterranean Diet: its definition and evaluation of a priori dietary indexes in primary cardiovascular prevention.

    Science.gov (United States)

    D'Alessandro, Annunziata; De Pergola, Giovanni

    2018-01-18

    We have analysed the definition of Mediterranean Diet in 28 studies included in six meta-analyses evaluating the relation between the Mediterranean Diet and primary prevention of cardiovascular disease. Some typical food of this dietary pattern like whole cereals, olive oil and red wine were taken into account only in a few a priori indexes, and the dietary pattern defined as Mediterranean showed many differences among the studies and compared to traditional Mediterranean Diet of the early 1960s. Altogether, the analysed studies show a protective effect of the Mediterranean Diet against cardiovascular disease but present different effects against specific conditions as cerebrovascular disease and coronary heart disease. These different effects might depend on the definition of Mediterranean Diet and the indexes of the adhesion to the same one used. To compare the effects of the Mediterranean Diet against cardiovascular disease, coronary heart disease and stroke a univocal model of Mediterranean Diet should be established as a reference, and it might be represented by the Modern Mediterranean Diet Pyramid. The a priori index to evaluate the adhesion to Mediterranean Diet might be the Mediterranean-Style Dietary Pattern Score that has some advantages in comparison to the others a priori indexes.

  17. Cardiovascular risk reduction by reversing endothelial dysfunction: ARBs, ACE inhibitors,  or both? Expectations from The ONTARGET  Trial Programme

    Directory of Open Access Journals (Sweden)

    Luis Miguel  Ruilope

    2007-03-01

    Full Text Available Luis Miguel  Ruilope1, Josep Redón2, Roland Schmieder31Servicio de Nefrologia, Unidad de Hipertension Hospital, 12 de Octubre, Madrid, Spain; 2Department of Internal Medicine, Hospital Clinico University of Valencia, Valencia, Spain; 3Department of Nephrology and Hypertension, Friedrich-Alexander-Universitat, Erlangen-Nurnberg, GermanyAbstract: Endothelial dysfunction is the initial pathophysiological step in a progression of vascular damage that leads to overt cardiovascular and chronic kidney disease. Angiotensin II, the primary agent of the renin–angiotensin system (RAS, has a central role in endothelial dysfunction. Therefore, RAS blockade with an angiotensin receptor blocker (ARB and/or angiotensin-converting enzyme (ACE inhibitor provides a rational approach to reverse endothelial dysfunction, reduce microalbuminuria, and, thus, improves cardiovascular and renal prognosis. ARBs and ACE inhibitors act at different points in the RAS pathway and recent evidence suggests that there are differences regarding their effects on endothelial dysfunction. In addition to blood pressure lowering, studies have shown that ARBs reduce target-organ damage, including improvements in endothelial dysfunction, arterial stiffness, the progression of renal dysfunction in patients with type 2 diabetes, proteinuria, and left ventricular hypertrophy. The ONgoing Telmisartan Alone in combination with Ramipril Global Endpoint Trial (ONTARGET Programme is expected to provide the ultimate evidence of whether improved endothelial func tion translates into reduced cardiovascular and renal events in high-risk patients, and to assess possible differential outcomes with telmisartan, the ACE inhibitor ramipril, or a combination of both (dual RAS blockade. Completion of ONTARGET is expected in 2008. Keywords: angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, endothelial dysfunction, ONTARGET, renin–angiotensin system, telmisartan

  18. Fabrication and evaluation of novel rabbit model cardiovascular simulator with 3D printer

    Science.gov (United States)

    Jang, Min; Lee, Min-Woo; Seo, See-Yoon; Shin, Sang-Hoon

    2017-03-01

    Simulators allow researchers to study the hemodynamics of the cardiovascular system in a reproducible way without using complicated equations. Previous simulators focused on heart functions. However, a detailed model of the vessels is required to replicate the pulse wave of the arterial system. A computer simulation was used to simplify the arterial branch because producing every small artery is neither possible nor necessary. A 3D-printed zig was used to make a hand-made arterial tree. The simulator that was developed was evaluated by comparing its results to in-vivo data, in terms of the hemodynamic parameters (waveform, augmentation index, impedance, etc.) that were measured at three points: the ascending aorta, the thoracic aorta, and the brachiocephalic artery. The results from the simulator showed good agreement with the in-vivo data. Therefore, this simulator can be used as a research tool for the cardiovascular study of animal models, specifically rabbits.

  19. Enriching Diet with n-3 PUFAs to Help Prevent Cardiovascular Diseases in Healthy Adults: Results from Clinical Trials

    Directory of Open Access Journals (Sweden)

    Matteo Manuelli

    2017-07-01

    Full Text Available Omega-3 polyunsaturated fatty acids (n-3 PUFAs are believed to be important for cardiovascular health. Many investigations have been carried out in an attempt to examine the effect of n-3 PUFAs intake, in the form of supplementation or fortified foods, for the management of cardiovascular disease (CVD and risk factors for CVD, whereas less is known about the effect on healthy individuals. The present study reviews the available literature in order to examine the relationship between n-3 PUFAs intake, either via supplementation or enriched food, and the prevention of CVD among healthy adults. Interventional clinical trials on subjects aged >18 years old with none of the established risk factors for CVD have been considered for review. n-3 PUFAs supplementation or enriched food may positively regulate triglycerides and some lipoprotein subsets, as well as several vascular and coagulation parameters, even in healthy patients, presenting no risk factors for CVD, suggesting a protective effect. Diet enrichment with omega-3 is likely to be useful in helping to lower the risk of developing CVD in healthy individuals, but still offers no strong evidence of a tangible benefit on a population level. Additional studies are needed to determine the optimal daily intake, especially to prevent the unfavorable effects of PUFAs over-consumption.

  20. Evaluation of the performance of existing non-laboratory based cardiovascular risk assessment algorithms

    Science.gov (United States)

    2013-01-01

    Background The high burden and rising incidence of cardiovascular disease (CVD) in resource constrained countries necessitates implementation of robust and pragmatic primary and secondary prevention strategies. Many current CVD management guidelines recommend absolute cardiovascular (CV) risk assessment as a clinically sound guide to preventive and treatment strategies. Development of non-laboratory based cardiovascular risk assessment algorithms enable absolute risk assessment in resource constrained countries. The objective of this review is to evaluate the performance of existing non-laboratory based CV risk assessment algorithms using the benchmarks for clinically useful CV risk assessment algorithms outlined by Cooney and colleagues. Methods A literature search to identify non-laboratory based risk prediction algorithms was performed in MEDLINE, CINAHL, Ovid Premier Nursing Journals Plus, and PubMed databases. The identified algorithms were evaluated using the benchmarks for clinically useful cardiovascular risk assessment algorithms outlined by Cooney and colleagues. Results Five non-laboratory based CV risk assessment algorithms were identified. The Gaziano and Framingham algorithms met the criteria for appropriateness of statistical methods used to derive the algorithms and endpoints. The Swedish Consultation, Framingham and Gaziano algorithms demonstrated good discrimination in derivation datasets. Only the Gaziano algorithm was externally validated where it had optimal discrimination. The Gaziano and WHO algorithms had chart formats which made them simple and user friendly for clinical application. Conclusion Both the Gaziano and Framingham non-laboratory based algorithms met most of the criteria outlined by Cooney and colleagues. External validation of the algorithms in diverse samples is needed to ascertain their performance and applicability to different populations and to enhance clinicians’ confidence in them. PMID:24373202

  1. Methods and baseline cardiovascular data from the Early versus Late Intervention Trial with Estradiol testing the menopausal hormone timing hypothesis.

    Science.gov (United States)

    Hodis, Howard N; Mack, Wendy J; Shoupe, Donna; Azen, Stanley P; Stanczyk, Frank Z; Hwang-Levine, Juliana; Budoff, Matthew J; Henderson, Victor W

    2015-04-01

    This study aims to present methods and baseline data from the Early versus Late Intervention Trial with Estradiol (ELITE), the only clinical trial designed to specifically test the timing hypothesis of postmenopausal hormone therapy (HT). The timing hypothesis posits that HT effects depend on the temporal initiation of HT relative to time since menopause. ELITE is a randomized, double-blind, placebo-controlled trial with a 2 × 2 factorial design. Six hundred forty-three healthy postmenopausal women without cardiovascular disease were randomized to oral estradiol or placebo for up to 6 to 7 years according to time since menopause (y). Carotid artery intima-media thickness (CIMT) and cardiac computed tomography were conducted to determine HT effects on subclinical atherosclerosis across menopause strata. Participants in the early and late postmenopausal strata were well-separated by mean age (55.4 vs 65.4 y) and median time since menopause (3.5 vs 14.3 y). Expected risk factors (age, blood pressure, and body mass index) were associated with CIMT at baseline in both strata. In the early postmenopausal group, but not in the late postmenopausal group, we observed significant associations between CIMT and factors that may play a role in the responsiveness of atherosclerosis progression according to timing of HT initiation. These include low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, sex hormone-binding globulin, and serum total estradiol. The ELITE randomized controlled trial is timely and unique. Baseline data indicate that ELITE is well-positioned to test the HT timing hypothesis in relation to atherosclerosis progression and coronary artery disease.

  2. HDL cholesterol and residual risk of first cardiovascular events after treatment with potent statin therapy: an analysis from the JUPITER trial

    DEFF Research Database (Denmark)

    Ridker, P.M.; Genest, J.; Boekholdt, S.M.

    2010-01-01

    Background HDL-cholesterol concentrations are inversely associated with occurrence of cardiovascular events. We addressed, using the JUPITER trial cohort, whether this association remains when LDL-cholesterol concentrations are reduced to the very low ranges with high-dose statin treatment. Metho...

  3. HDL cholesterol and residual risk of first cardiovascular events after treatment with potent statin therapy: an analysis from the JUPITER trial

    NARCIS (Netherlands)

    Ridker, Paul M.; Genest, Jacques; Boekholdt, S. Matthijs; Libby, Peter; Gotto, Antonio M.; Nordestgaard, Børge G.; Mora, Samia; Macfadyen, Jean G.; Glynn, Robert J.; Kastelein, John Jp

    2010-01-01

    Background HDL-cholesterol concentrations are inversely associated with occurrence of cardiovascular events. We addressed, using the JUPITER trial cohort, whether this association remains when LDL-cholesterol concentrations are reduced to the very low ranges with high-dose statin treatment. Methods

  4. Evaluating the Flipped Classroom: A Randomized Controlled Trial

    Science.gov (United States)

    Wozny, Nathan; Balser, Cary; Ives, Drew

    2018-01-01

    Despite recent interest in flipped classrooms, rigorous research evaluating their effectiveness is sparse. In this study, the authors implement a randomized controlled trial to evaluate the effect of a flipped classroom technique relative to a traditional lecture in an introductory undergraduate econometrics course. Random assignment enables the…

  5. Using Randomized Controlled Trials to Evaluate Interventions for Releasing Prisoners

    Science.gov (United States)

    Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia

    2016-01-01

    Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community…

  6. Plasma branched-chain amino acids and incident cardiovascular disease in the PREDIMED trial

    Science.gov (United States)

    Ruiz-Canela, Miguel; Toledo, Estefania; Clish, Clary B.; Hruby, Adela; Liang, Liming; Salas-Salvadó, Jordi; Razquin, Cristina; Corella, Dolores; Estruch, Ramón; Ros, Emilio; Fitó, Montserrat; Gómez-Gracia, Enrique; Arós, Fernando; Fiol, Miquel; Lapetra, José; Serra-Majem, Lluis; Martínez-González, Miguel A.; Hu, Frank B.

    2016-01-01

    Background The role of branched-chain amino acids (BCAAs) in cardiovascular disease (CVD) remains poorly understood. We hypothesized that baseline BCAA concentrations predict future risk of CVD and that a Mediterranean Diet (MedDiet) intervention may counteract this effect. Methods We developed a case-cohort study within the “PREvención con DIeta MEDiterránea” (PREDIMED), with 226 incident CVD cases and 781 non-cases. We used LC-MS/MS to measure plasma BCAAs (leucine, isoleucine and valine), both at baseline and after 1-year follow-up. The primary outcome was a composite of incident stroke, myocardial infarction, or cardiovascular death. Results After adjustment for potential confounders, baseline leucine and isoleucine concentrations were associated with higher CVD risk: the hazard ratios (HRs) for the highest vs. lowest quartile were 1.70 (95% confidence interval, 1.05–2.76) and 2.09 (1.27–3.44), respectively. Stronger associations were found for stroke. For both CVD and stroke, we found higher HRs across successive quartiles of BCAAs in the control group than in the MedDiet groups. Using stroke as the outcome, a significant interaction (P=0.009) between the baseline BCAA score and the intervention with MedDiet was observed. No significant effect of the intervention on 1-yr changes in BCAAs nor any association between 1-year changes in BCAAs and CVD were observed. Conclusions Higher concentrations of baseline BCAAs were associated with increased risk of CVD, especially stroke, in a high cardiovascular risk population. A Mediterranean-style diet had a negligible effect on 1-year changes in BCAAs, but it may counteract the harmful effects of BCAAs on stroke. PMID:26888892

  7. Cardiovascular Deconditioning

    Science.gov (United States)

    Charles, John B.; Fritsch-Yelle, Janice M.; Whitson, Peggy A.; Wood, Margie L.; Brown, Troy E.; Fortner, G. William

    1999-01-01

    Spaceflight causes adaptive changes in cardiovascular function that may deleteriously affect crew health and safety. Over the last three decades, symptoms of cardiovascular changes have ranged from postflight orthostatic tachycardia and decreased exercise capacity to serious cardiac rhythm disturbances during extravehicular activities (EVA). The most documented symptom of cardiovascular dysfunction, postflight orthostatic intolerance, has affected a significant percentage of U.S. Space Shuttle astronauts. Problems of cardiovascular dysfunction associated with spaceflight are a concern to NASA. This has been particularly true during Shuttle flights where the primary concern is the crew's physical health, including the pilot's ability to land the Orbiter, and the crew's ability to quickly egress and move to safety should a dangerous condition arise. The study of astronauts during Shuttle activities is inherently more difficult than most human research. Consequently, sample sizes have been small and results have lacked consistency. Before the Extended Duration Orbiter Medical Project (EDOMP), there was a lack of normative data on changes in cardiovascular parameters during and after spaceflight. The EDOMP for the first time allowed studies on a large enough number of subjects to overcome some of these problems. There were three primary goals of the Cardiovascular EDOMP studies. The first was to establish, through descriptive studies, a normative data base of cardiovascular changes attributable to spaceflight. The second goal was to determine mechanisms of cardiovascular changes resulting from spaceflight (particularly orthostatic hypotension and cardiac rhythm disturbances). The third was to evaluate possible countermeasures. The Cardiovascular EDOMP studies involved parallel descriptive, mechanistic, and countermeasure evaluations.

  8. Beneficial effect of a polyphenol-rich diet on cardiovascular risk: a randomised control trial.

    Science.gov (United States)

    Noad, Rebecca L; Rooney, Ciara; McCall, Damian; Young, Ian S; McCance, David; McKinley, Michelle C; Woodside, Jayne V; McKeown, Pascal P

    2016-09-01

    There is previous epidemiological evidence that intake of polyphenol-rich foods has been associated with reduced cardiovascular disease risk. We aimed to investigate the effect of increasing dietary polyphenol intake on microvascular function in hypertensive participants. All participants completed a 4-week run-in phase, consuming polyphenol diet for 8 weeks or to consume a high-polyphenol diet of six portions F&V (including one portion of berries/day and 50 g of dark chocolate). Endothelium-dependent (acetylcholine, ACh) and endothelium-independent (sodium nitroprusside) vasodilator responses were assessed by venous occlusion plethysmography. Compliance with the intervention was measured using food diaries and biochemical markers. Final analysis of the primary endpoint was conducted on 92 participants. Between-group comparison of change in maximum % response to ACh revealed a significant improvement in the high-polyphenol group (p=0.02). There was a significantly larger increase in vitamin C, carotenoids and epicatechin in the high-polyphenol group (between-group difference ppolyphenol content of the diet via consumption of F&V, berries and dark chocolate results in a significant improvement in an established marker of cardiovascular risk in hypertensive participants. NCT01319786. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  9. The Mediterranean Diet decreases LDL atherogenicity in high cardiovascular risk individuals: a randomized controlled trial.

    Science.gov (United States)

    Hernáez, Álvaro; Castañer, Olga; Goday, Alberto; Ros, Emilio; Pintó, Xavier; Estruch, Ramón; Salas-Salvadó, Jordi; Corella, Dolores; Arós, Fernando; Serra-Majem, Lluis; Martínez-González, Miguel Ángel; Fiol, Miquel; Lapetra, José; de la Torre, Rafael; López-Sabater, M Carmen; Fitó, Montserrat

    2017-09-01

    Traditional Mediterranean diet (TMD) protects against cardiovascular disease through several mechanisms such as decreasing LDL cholesterol levels. However, evidence regarding TMD effects on LDL atherogenic traits (resistance against oxidation, size, composition, cytotoxicity) is scarce. We assessed the effects of a 1-year intervention with a TMD on LDL atherogenic traits in a random sub-sample of individuals from the PREDIMED study (N = 210). We compared two TMDs: one enriched with virgin olive oil (TMD-VOO, N = 71) and another with nuts (TMD-Nuts, N = 68), versus a low-fat control diet (N = 71). After the TMD-VOO intervention, LDL resistance against oxidation increased (+6.46%, p = 0.007), the degree of LDL oxidative modifications decreased (-36.3%, p<0.05), estimated LDL particle size augmented (+3.06%, p = 0.021), and LDL particles became cholesterol-rich (+2.41% p = 0.013) relative to the low-fat control diet. LDL lipoproteins became less cytotoxic for macrophages only relative to baseline (-13.4%, p = 0.019). No significant effects of the TMD-Nuts intervention on LDL traits were observed versus the control diet. Adherence to a TMD, particularly when enriched with virgin olive oil, decreased LDL atherogenicity in high cardiovascular risk individuals. The development of less atherogenic LDLs could contribute to explaining some of the cardioprotective benefits of this dietary pattern. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  10. Converging evidence that subliminal evaluative conditioning does not affect self‐esteem or cardiovascular activity

    Science.gov (United States)

    Verkuil, Bart; Brosschot, Jos F.

    2017-01-01

    Abstract Self‐esteem moderates the relationship between stress and (cardiovascular) health, with low self‐esteem potentially exacerbating the impact of stressors. Boosting self‐esteem may therefore help to buffer against stress. Subliminal evaluative conditioning (SEC), which subliminally couples self‐words with positive words, has previously been successfully used to boost self‐esteem, but the existing studies are in need of replication. In this article, we aimed to replicate and extend previous SEC studies. The first 2 experiments simultaneously examined whether SEC increased self‐esteem (Experiment 1, n = 84) and reduced cardiovascular reactivity to a stressor in high worriers (Experiment 2, n = 77). On the basis of these results, the 3rd experiment was set up to examine whether an adjusted personalized SEC task increased self‐esteem and reduced cardiac activity in high worriers (n = 81). Across the 3 experiments, no effects were found of SEC on implicit or explicit self‐esteem or affect or on cardiovascular (re)activity compared to a control condition in which the self was coupled with neutral words. The results do not support the use of the subliminal intervention in its current format. As stress is highly prevalent, future studies should focus on developing other cost‐effective and evidence‐based interventions. PMID:28795525

  11. Converging evidence that subliminal evaluative conditioning does not affect self-esteem or cardiovascular activity.

    Science.gov (United States)

    Versluis, Anke; Verkuil, Bart; Brosschot, Jos F

    2018-04-01

    Self-esteem moderates the relationship between stress and (cardiovascular) health, with low self-esteem potentially exacerbating the impact of stressors. Boosting self-esteem may therefore help to buffer against stress. Subliminal evaluative conditioning (SEC), which subliminally couples self-words with positive words, has previously been successfully used to boost self-esteem, but the existing studies are in need of replication. In this article, we aimed to replicate and extend previous SEC studies. The first 2 experiments simultaneously examined whether SEC increased self-esteem (Experiment 1, n = 84) and reduced cardiovascular reactivity to a stressor in high worriers (Experiment 2, n = 77). On the basis of these results, the 3rd experiment was set up to examine whether an adjusted personalized SEC task increased self-esteem and reduced cardiac activity in high worriers (n = 81). Across the 3 experiments, no effects were found of SEC on implicit or explicit self-esteem or affect or on cardiovascular (re)activity compared to a control condition in which the self was coupled with neutral words. The results do not support the use of the subliminal intervention in its current format. As stress is highly prevalent, future studies should focus on developing other cost-effective and evidence-based interventions. © 2017 The Authors. Stress and Health Published by John Wiley & Sons Ltd.

  12. Primary prevention of stroke and cardiovascular disease in the community (PREVENTS): Methodology of a health wellness coaching intervention to reduce stroke and cardiovascular disease risk, a randomized clinical trial.

    Science.gov (United States)

    Mahon, Susan; Krishnamurthi, Rita; Vandal, Alain; Witt, Emma; Barker-Collo, Suzanne; Parmar, Priya; Theadom, Alice; Barber, Alan; Arroll, Bruce; Rush, Elaine; Elder, Hinemoa; Dyer, Jesse; Feigin, Valery

    2018-02-01

    Rationale Stroke is a major cause of death and disability worldwide, yet 80% of strokes can be prevented through modifications of risk factors and lifestyle and by medication. While management strategies for primary stroke prevention in high cardiovascular disease risk individuals are well established, they are underutilized and existing practice of primary stroke prevention are inadequate. Behavioral interventions are emerging as highly promising strategies to improve cardiovascular disease risk factor management. Health Wellness Coaching is an innovative, patient-focused and cost-effective, multidimensional psychological intervention designed to motivate participants to adhere to recommended medication and lifestyle changes and has been shown to improve health and enhance well-being. Aims and/or hypothesis To determine the effectiveness of Health Wellness Coaching for primary stroke prevention in an ethnically diverse sample including Māori, Pacific Island, New Zealand European and Asian participants. Design A parallel, prospective, randomized, open-treatment, single-blinded end-point trial. Participants include 320 adults with absolute five-year cardiovascular disease risk ≥ 10%, calculated using the PREDICT web-based clinical tool. Randomization will be to Health Wellness Coaching or usual care groups. Participants randomized to Health Wellness Coaching will receive 15 coaching sessions over nine months. Study outcomes A substantial relative risk reduction of five-year cardiovascular disease risk at nine months post-randomization, which is defined as 10% relative risk reduction among those at moderate five-year cardiovascular disease risk (10-15%) and 25% among those at high risk (>15%). Discussion This clinical trial will determine whether Health Wellness Coaching is an effective intervention for reducing modifiable risk factors, and hence decrease the risk of stroke and cardiovascular disease.

  13. A PROgramme of Lifestyle Intervention in Families for Cardiovascular risk reduction (PROLIFIC Study: design and rationale of a family based randomized controlled trial in individuals with family history of premature coronary heart disease

    Directory of Open Access Journals (Sweden)

    Panniyammakal Jeemon

    2017-01-01

    Full Text Available Abstract Background Recognizing patterns of coronary heart disease (CHD risk in families helps to identify and target individuals who may have the most to gain from preventive interventions. The overall goal of the study is to test the effectiveness and sustainability of an integrated care model for managing cardiovascular risk in high risk families. The proposed care model targets the structural and environmental conditions that predispose high risk families to development of CHD through the following interventions: 1 screening for cardiovascular risk factors, 2 providing lifestyle interventions 3 providing a framework for linkage to appropriate primary health care facility, and 4 active follow-up of intervention adherence. Methods Initially, a formative qualitative research component will gather information on understanding of diseases, barriers to care, specific components of the intervention package and feedback on the intervention. Then a cluster randomized controlled trial involving 740 families comprising 1480 participants will be conducted to determine whether the package of interventions (integrated care model is effective in reducing or preventing the progression of CHD risk factors and risk factor clustering in families. The sustainability and scalability of this intervention will be assessed through economic (cost-effectiveness analyses and qualitative evaluation (process outcomes to estimate value and acceptability. Scalability is informed by cost-effectiveness and acceptability of the integrated cardiovascular risk reduction approach. Discussion Knowledge generated from this trial has the potential to significantly affect new programmatic policy and clinical guidelines that will lead to improvements in cardiovascular health in India. Trial registration number NCT02771873, registered in May 2016 ( https://clinicaltrials.gov/ct2/show/results/NCT02771873

  14. HDL cholesterol and residual risk of first cardiovascular events after treatment with potent statin therapy: an analysis from the JUPITER trial

    DEFF Research Database (Denmark)

    Ridker, P.M.; Genest, J.; Boekholdt, S.M.

    2010-01-01

    by a computer-generated sequence to receive rosuvastatin 20 mg per day or placebo, with participants and adjudicators masked to treatment assignment. In the present analysis, we divided the participants into quartiles of HDL-cholesterol or apolipoprotein A1 and sought evidence of association between...... these quartiles and the JUPITER primary endpoint of first non-fatal myocardial infarction or stroke, hospitalisation for unstable angina, arterial revascularisation, or cardiovascular death. This trial is registered with ClinicalTrials.gov, number NCT00239681. Findings For 17802 patients in the JUPITER trial...

  15. Aspirin for Primary Prevention of Cardiovascular Events: Meta-Analysis of Randomized Controlled Trials and Subgroup Analysis by Sex and Diabetes Status

    Science.gov (United States)

    Zhang, Yan; Chen, Sijing; Yang, Wei; Bao, Wei; Rong, Ying; Yu, Xuefeng; Hu, Frank B.; Liu, Liegang

    2014-01-01

    Objective To evaluate the benefits and harms of aspirin for the primary prevention of CVD and determine whether the effects vary by sex and diabetes status. Methods We searched Medline, Embase, and Cochrane databases for randomized controlled trials comparing the effects of aspirin with placebo or control in people with no pre-existing CVD. Two investigators independently extracted data and assessed the study quality. Analyses were performed using Stata version 12. Results Fourteen trials (107,686 participants) were eligible. Aspirin was associated with reductions in major cardiovascular events (risk ratio, 0.90; 95% confidence interval, 0.85–0.95), myocardial infarction (0.86; 0.75–0.93), ischemic stroke (0.86; 0.75–0.98) and all-cause mortality (0.94; 0.89–0.99). There were also increases in hemorrhagic stroke (1.34; 1.01–1.79) and major bleeding (1.55; 1.35–1.78) with aspirin. The number needed to treat to prevent 1 major cardiovascular event over a mean follow-up of 6.8 years was 284. By comparison, the numbers needed to harm to cause 1 major bleeding is 299. In subgroup analyses, pooled results demonstrated a reduction in myocardial infarction among men (0.71; 0.59–0.85) and ischemic stroke among women (0.77; 0.63–0.93). Aspirin use was associated with a reduction (0.65; 0.51–0.82) in myocardial infarction among diabetic men. In meta-regression analyses, the results suggested that aspirin therapy might be associated with a decrease in stroke among diabetic women and a decrease in MI among diabetic men and risk reductions achieved with low doses (75 mg/day) were as large as those obtained with higher doses (650 mg/day). Conclusions The use of low-dose aspirin was beneficial for primary prevention of CVD and the decision regarding an aspirin regimen should be made on an individual patient basis. The effects of aspirin therapy varied by sex and diabetes status. A clear benefit of aspirin in the primary prevention of CVD in people with diabetes

  16. Short and long term effects of a lifestyle intervention for construction workers at risk for cardiovascular disease: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Groeneveld Iris F

    2011-10-01

    Full Text Available Abstract Background The prevalence of overweight and elevated cardiovascular disease (CVD risk among workers in the construction industry is relatively high. Improving lifestyle lowers CVD risk and may have work-related benefits. The purpose of the study was to evaluate the effects on physical activity (PA, diet, and smoking of a lifestyle intervention consisting of individual counseling among male workers in the construction industry with an elevated risk of cardiovascular disease (CVD. Methods In a randomized controlled trial including 816 male blue- and white-collar workers in the construction industry with an elevated risk of CVD, usual care was compared to a 6-month lifestyle intervention. The intervention consisted of individual counseling using motivational interviewing techniques, and was delivered by an occupational physician or occupational nurse. In three face to face and four telephone contacts, the participant's risk profile, personal determinants, and barriers for behavior change were discussed, and personal goals were set. Participants chose to aim at either diet and PA, or smoking. Data were collected at baseline and after six and 12 months, by means of a questionnaire. To analyse the data, linear and logistic regression analyses were performed. Results The intervention had a statistically significant beneficial effect on snack intake (β-1.9, 95%CI -3.7; -0.02 and fruit intake (β 1.7, 95%CI 0.6; 2.9 at 6 months. The effect on snack intake was sustained until 12 months; 6 months after the intervention had ended (β -1.9, 95%CI -3.6; -0.2. The intervention effects on leisure time PA and metabolic equivalent-minutes were not statistically significant. The beneficial effect on smoking was statistically significant at 6 (OR smoking 0.3, 95%CI 0.1;0.7, but not at 12 months (OR 0.8, 95%CI 0.4; 1.6. Conclusions Beneficial effects on smoking, fruit, and snack intake can be achieved by an individual-based lifestyle intervention among

  17. L-arginine supplementation and risk factors of cardiovascular diseases in healthy men: a double-blind randomized clinical trial [version 2; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Naseh Pahlavani

    2017-06-01

    Full Text Available Context: The effect of L-arginine on risk factors of cardiovascular diseases (CVD has mostly focused on western countries. Since cardiovascular diseases is the second cause of death in Iran and, as far as we are aware, there have been no studies about the effect of L-arginine on CVD risk factors, the aim of this trial was to assess the effects of L-arginine supplementation on CVD risk factors in healthy men. Objective: The purpose of this study was to evaluate the effect of low-dose L-arginine supplementation on CVD risk factors (lipid profile, blood sugar and blood pressure in Iranian healthy men. Design, setting, participants: We conducted a double-blind randomized controlled trial in 56 patients selected from sport clubs at the Isfahan University of Medical Science between November 2013 and December 2013. Interventions: Healthy men received L-arginine supplementation (2000 mg daily in the intervention group or placebo (2000 mg maltodextrin daily in the control group for 45 days. Main outcome measure: The primary outcome measures were we measured the levels of fasting blood sugar, blood pressure and lipid profile including triglyceride (TG, cholesterol, LDL and HDL in healthy subjects. It was hypothesized that these measures would be significantly improved in those receiving L–arginine supplementation. at the beginning and end of the study. Results: In this trial, we had complete data for 52 healthy participants with mean age of 20.85±4.29 years. At the end of study, fasting blood sugar (P=0.001 and lipid profile (triglycerideTG (P<0.001, cholesterol (P<0.001, LDL (P=0.04, HDL (P=0.015 decreased in the L-arginine group but we found no significant change in the placebo group. In addition, the reduction of fasting blood sugar and lipid profile in L-arginine was significant compared with placebo group. No significant changes were found about systolic (P=0.81 and diastolic blood pressure either in L-arginine or placebo group. (P=0

  18. Does anaesthesia with nitrous oxide affect mortality or cardiovascular morbidity? A systematic review with meta-analysis and trial sequential analysis.

    Science.gov (United States)

    Imberger, G; Orr, A; Thorlund, K; Wetterslev, J; Myles, P; Møller, A M

    2014-03-01

    The role of nitrous oxide in modern anaesthetic practice is contentious. One concern is that exposure to nitrous oxide may increase the risk of cardiovascular complications. ENIGMA II is a large randomized clinical trial currently underway which is investigating nitrous oxide and cardiovascular complications. Before the completion of this trial, we performed a systematic review and meta-analysis, using Cochrane methodology, on the outcomes that make up the composite primary outcome. We used conventional meta-analysis and trial sequential analysis (TSA). We reviewed 8282 abstracts and selected 138 that fulfilled our criteria for study type, population, and intervention. We attempted to contact the authors of all the selected publications to check for unpublished outcome data. Thirteen trials had outcome data eligible for our outcomes. We assessed three of these trials as having a low risk of bias. Using conventional meta-analysis, the relative risk of short-term mortality in the nitrous oxide group was 1.38 [95% confidence interval (CI) 0.22-8.71] and the relative risk of long-term mortality in the nitrous oxide group was 0.94 (95% CI 0.80-1.10). In both cases, TSA demonstrated that the data were far too sparse to make any conclusions. There were insufficient data to perform meta-analysis for stroke, myocardial infarct, pulmonary embolus, or cardiac arrest. This systematic review demonstrated that we currently do not have robust evidence for how nitrous oxide used as part of general anaesthesia affects mortality and cardiovascular complications.

  19. Effect of soy on metabolic syndrome and cardiovascular risk factors: a randomized controlled trial.

    Science.gov (United States)

    Ruscica, Massimiliano; Pavanello, Chiara; Gandini, Sara; Gomaraschi, Monica; Vitali, Cecilia; Macchi, Chiara; Morlotti, Beatrice; Aiello, Gilda; Bosisio, Raffaella; Calabresi, Laura; Arnoldi, Anna; Sirtori, Cesare R; Magni, Paolo

    2018-03-01

    Cardiovascular diseases are currently the commonest cause of death worldwide. Different strategies for their primary prevention have been planned, taking into account the main known risk factors, which include an atherogenic lipid profile and visceral fat excess. The study was designed as a randomized, parallel, single-center study with a nutritional intervention duration of 12 weeks. Whole soy foods corresponding to 30 g/day soy protein were given in substitution of animal foods containing the same protein amount. Soy nutritional intervention resulted in a reduction in the number of MetS features in 13/26 subjects. Moreover, in the soy group we observed a significant improvement of median percentage changes for body weight (-1.5 %) and BMI (-1.5 %), as well as for atherogenic lipid markers, namely TC (-4.85 %), LDL-C (-5.25 %), non-HDL-C (-7.14 %) and apoB (-14.8 %). Since the majority of the studied variables were strongly correlated, three factors were identified which explained the majority (52 %) of the total variance in the whole data set. Among them, factor 1, which loaded lipid and adipose variables, explained the 22 % of total variance, showing a statistically significant difference between treatment arms (p = 0.002). The inclusion of whole soy foods (corresponding to 30 g/day protein) in a lipid-lowering diet significantly improved a relevant set of biomarkers associated with cardiovascular risk.

  20. Effects of oral lycopene supplementation on vascular function in patients with cardiovascular disease and healthy volunteers: a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Parag R Gajendragadkar

    Full Text Available AIMS: The mechanisms by which a 'Mediterranean diet' reduces cardiovascular disease (CVD burden remain poorly understood. Lycopene is a potent antioxidant found in such diets with evidence suggesting beneficial effects. We wished to investigate the effects of lycopene on the vasculature in CVD patients and separately, in healthy volunteers (HV. METHODS AND RESULTS: We randomised 36 statin treated CVD patients and 36 healthy volunteers in a 2∶1 treatment allocation ratio to either 7 mg lycopene or placebo daily for 2 months in a double-blind trial. Forearm responses to intra-arterial infusions of acetylcholine (endothelium-dependent vasodilatation; EDV, sodium nitroprusside (endothelium-independent vasodilatation; EIDV, and NG-monomethyl-L-arginine (basal nitric oxide (NO synthase activity were measured using venous plethysmography. A range of vascular and biochemical secondary endpoints were also explored. EDV in CVD patients post-lycopene improved by 53% (95% CI: +9% to +93%, P = 0.03 vs. placebo without changes to EIDV, or basal NO responses. HVs did not show changes in EDV after lycopene treatment. Blood pressure, arterial stiffness, lipids and hsCRP levels were unchanged for lycopene vs. placebo treatment groups in the CVD arm as well as the HV arm. At baseline, CVD patients had impaired EDV compared with HV (30% lower; 95% CI: -45% to -10%, P = 0.008, despite lower LDL cholesterol (1.2 mmol/L lower, 95% CI: -1.6 to -0.9 mmol/L, P<0.001. Post-therapy EDV responses for lycopene-treated CVD patients were similar to HVs at baseline (2% lower, 95% CI: -30% to +30%, P = 0.85, also suggesting lycopene improved endothelial function. CONCLUSIONS: Lycopene supplementation improves endothelial function in CVD patients on optimal secondary prevention, but not in HVs. TRIAL REGISTRATION: ClinicalTrials.gov NCT01100385.

  1. Agreement between public register and adjudication committee outcome in a cardiovascular randomized clinical trial

    DEFF Research Database (Denmark)

    Kjøller, Erik; Hilden, Jørgen; Winkel, Per

    2014-01-01

    UNLABELLED: The objective of this study is to describe the agreement between randomized trial outcome assessment by committee and outcomes entirely identified through public registers. METHODS: In the CLARICOR trial, 4,372 patients with stable coronary heart disease received a short course...... of Diseases-coded diagnoses of the public registries into the same categories. After cross-tabulation of the committee diagnoses with National Patient Register diagnoses and Register of Causes of Death, we calculate agreement and compare the estimated intervention effects of the 2 data sets. RESULTS......: With public register data, the protocol-specified categories were slightly more frequent. Overall agreement was 74% for hospital discharges and 60% for cause of death, but the intervention effect, expressed as a hazard ratio, stayed within 4% of the value originally obtained with the adjudication committee (P...

  2. Effects of Social Exclusion on Cardiovascular and Affective Reactivity to a Socially Evaluative Stressor.

    Science.gov (United States)

    Williamson, Timothy J; Thomas, KaMala S; Eisenberger, Naomi I; Stanton, Annette L

    2018-04-03

    Socially disconnected individuals have worse health than those who feel socially connected. The mechanisms through which social disconnection influences physiological and psychological outcomes warrant study. The current study tested whether experimental manipulations of social exclusion, relative to inclusion, influenced subsequent cardiovascular (CV) and affective reactivity to socially evaluative stress. Young adults (N = 81) were assigned through block randomization to experience either social exclusion or inclusion, using a standardized computer-based task (Cyberball). Immediately after exposure to Cyberball, participants either underwent a socially evaluative stressor or an active control task, based on block randomization. Physiological activity (systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR)) and state anxiety were assessed throughout the experiment. Excluded participants evidenced a significant increase in cardiovascular and affective responses to a socially evaluative stressor. Included participants who underwent the stressor evidenced similar increases in anxiety, but systolic blood pressure, diastolic blood pressure, and heart rate did not change significantly in response to the stressor. Results contribute to the understanding of physiological consequences of social exclusion. Further investigation is needed to test whether social inclusion can buffer CV stress reactivity, which would carry implications for how positive social factors may protect against the harmful effects of stress.

  3. The Brazilian Cardioprotective Nutritional Program to reduce events and risk factors in secondary prevention for cardiovascular disease: study protocol (The BALANCE Program Trial).

    Science.gov (United States)

    Weber, Bernardete; Bersch-Ferreira, Ângela Cristine; Torreglosa, Camila Ragne; Ross-Fernandes, Maria Beatriz; da Silva, Jacqueline Tereza; Galante, Andrea Polo; Lara, Enilda de Sousa; Costa, Rosana Perim; Soares, Rafael Marques; Cavalcanti, Alexandre Biasi; Moriguchi, Emilio H; Bruscato, Neide M; Kesties; Vivian, Lilian; Schumacher, Marina; de Carli, Waldemar; Backes, Luciano M; Reolão, Bruna R; Rodrigues, Milena P; Baldissera, Dúnnia M B; Tres, Glaucia S; Lisbôa, Hugo R K; Bem, João B J; Reolão, Jose B C; Deucher, Keyla L A L; Cantarelli, Maiara; Lucion, Aline; Rampazzo, Daniela; Bertoni, Vanessa; Torres, Rosileide S; Verríssimo, Adriana O L; Guterres, Aldair S; Cardos, Andrea F R; Coutinho, Dalva B S; Negrão, Mayara G; Alencar, Mônica F A; Pinho, Priscila M; Barbosa, Socorro N A A; Carvalho, Ana P P F; Taboada, Maria I S; Pereira, Sheila A; Heyde, Raul V; Nagano, Francisca E Z; Baumgartner, Rebecca; Resende, Fernanda P; Tabalipa, Ranata; Zanini, Ana C; Machado, Michael J R; Araujo, Hevila; Teixeira, Maria L V; Souza, Gabriela C; Zuchinali, Priccila; Fracasso, Bianca M; Ulliam, Karen; Schumacher, Marina; Pierotto, Moara; Hilário, Thamires; Carlos, Daniele M O; Cordeiro, Cintia G N C; Carvalho, Daniele A; Gonçalves, Marília S; Vasconcelos, Valdiana B; Bosquetti, Rosa; Pagano, Raira; Romano, Marcelo L P; Jardim, César A; de Abreu, Bernardo N A; Marcadenti, Aline; Schmitt, Alessandra R; Tavares, Angela M V; Faria, Christiane C; Silva, Flávia M; Fink, Jaqueline S; El Kik, Raquel M; Prates, Clarice F; Vieira, Cristiane S; Adorne, Elaine F; Magedanz, Ellen H; Chieza, Fernanda L; Silva, Ingrid S; Teixeira, Joise M; Trescastro, Eduardo P; Pellegrini, Lívia A; Pinto, Jéssika C; Telles, Cristina T; Sousa, Antonio C S; Almeida, Andreza S; Costa, Ariane A; Carmo, José A C; Silva, Juliana T; Alves, Luciana V S; Sales, Saulo O C; Ramos, Maria E M; Lucas, Marilia C S; Damiani, Monica; Cardoso, Patricia C; Ramos, Salvador S; Dantas, Clenise F; Lopes, Amanda G; Cabral, Ana M P; Lucena, Ana C A; Medeiros, Auriene L; Terceiro, Bernardino B; Leda, Neuma M F S; Baía, Sandra R D; Pinheiro, Josilene M F; Cassiano, Alexandra N; Melo, Andressa N L; Cavalcanti, Anny K O; Souza, Camila V S; Queiroz, Dayanna J M; Farias, Hercilla N C F; Souza, Larissa C F; Santos, Letícia S; Lima, Luana R M; Hoffmann, Meg S; Ribeiro, Átala S Silva; Vasconcelos, Daniel F; Dutra, Eliane S; Ito, Marina K; Neto, José A F; Santos, Alexsandro F; Sousa, Rosângela M L; Dias, Luciana Pereira P; Lima, Maria T M A; Modanesi, Victor G; Teixeira, Adriana F; Estrada, Luciana C N C D; Modanesi, Paulo V G; Gomes, Adriana B L; Rocha, Bárbara R S; Teti, Cristina; David, Marta M; Palácio, Bruna M; Junior, Délcio G S; Faria, Érica H S; Oliveira, Michelle C F; Uehara, Rose M; Sasso, Sandramara; Moreira, Annie S B; Cadinha, Ana C A H; Pinto, Carla W M; Castilhos, Mariana P; Costa, Mariana; Kovacs, Cristiane; Magnoni, Daniel; Silva, Quênia; Germini, Michele F C A; da Silva, Renata A; Monteiro, Aline S; dos Santos, Karina G; Moreira, Priscila; Amparo, Fernanda C; Paiva, Catharina C J; Poloni, Soraia; Russo, Diana S; Silveira, Izabele V; Moraes, Maria A; Boklis, Mirena; Cardoso, Quinto I; Moreira, Annie S B; Damaceno, Aline M S; Santos, Elisa M; Dias, Glauber M; Pinho, Cláudia P S; Cavalcanti, Adrilene C; Bezerra, Amanda S; Queiroga, Andrey V; Rodrigues, Isa G; Leal, Tallita V; Sahade, Viviane; Amaral, Daniele A; Souza, Diana S; Araújo, Givaldo A; Curvello, Karine; Heine, Manuella; Barretto, Marília M S; Reis, Nailson A; Vasconcelos, Sandra M L; Vieira, Danielly C; Costa, Francisco A; Fontes, Jessica M S; Neto, Juvenal G C; Navarro, Laís N P; Ferreira, Raphaela C; Marinho, Patrícia M; Abib, Renata Torres; Longo, Aline; Bertoldi, Eduardo G; Ferreira, Lauren S; Borges, Lúcia R; Azevedo, Norlai A; Martins, Celma M; Kato, Juliana T; Izar, Maria C O; Asoo, Marina T; de Capitani, Mariana D; Machado, Valéria A; Fonzar, Waléria T; Pinto, Sônia L; Silva, Kellen C; Gratão, Lúcia H A; Machado, Sheila D; de Oliveira, Susane R U; Bressan, Josefina; Caldas, Ana P S; Lima, Hatanne C F M; Hermsdorff, Helen H M; Saldanha, Tânia M; Priore, Sílvia E; Feres, Naoel H; Neves, Adila de Queiroz; Cheim, Loanda M G; Silva, Nilma F; Reis, Silvia R L; Penafort, Andreza M; de Queirós, Ana Paula O; Farias, Geysa M N; de los Santos, Mônica L P; Ambrozio, Cíntia L; Camejo, Cirília N; dos Santos, Cristiano P; Schirmann, Gabriela S; Boemo, Jorge L; Oliveira, Rosane E C; Lima, Súsi M B; Bortolini, Vera M S; Matos, Cristina H; Barretta, Claiza; Specht, Clarice M; de Souza, Simone R; Arruda, Cristina S; Rodrigues, Priscila A; Berwanger, Otávio

    2016-01-01

    This article reports the rationale for the Brazilian Cardioprotective Nutritional Program (BALANCE Program) Trial. This pragmatic, multicenter, nationwide, randomized, concealed, controlled trial was designed to investigate the effects of the BALANCE Program in reducing cardiovascular events. The BALANCE Program consists of a prescribed diet guided by nutritional content recommendations from Brazilian national guidelines using a unique nutritional education strategy, which includes suggestions of affordable foods. In addition, the Program focuses on intensive follow-up through one-on-one visits, group sessions, and phone calls. In this trial, participants 45 years or older with any evidence of established cardiovascular disease will be randomized to the BALANCE or control groups. Those in the BALANCE group will receive the afore mentioned program interventions, while controls will be given generic advice on how to follow a low-fat, low-energy, low-sodium, and low-cholesterol diet, with a view to achieving Brazilian nutritional guideline recommendations. The primary outcome is a composite of death (any cause), cardiac arrest, acute myocardial infarction, stroke, myocardial revascularization, amputation for peripheral arterial disease, or hospitalization for unstable angina. A total of 2468 patients will be enrolled in 34 sites and followed up for up to 48 months. If the BALANCE Program is found to decrease cardiovascular events and reduce risk factors, this may represent an advance in the care of patients with cardiovascular disease. Copyright © 2015 Elsevier Inc. All rights reserved.

  4. Does quercetin improve cardiovascular risk factors and inflammatory biomarkers in women with type 2 diabetes: A double-blind randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Maryam Zahedi

    2013-01-01

    Full Text Available Background: Quercetin has been distributed in a wide range of foods, but some of its known effects in vitro, are not proven in human studies. Therefore, the aim of this study was evaluation of the effects of quercetin intake on cardiovascular risk factors and inflammatory biomarkers in women with type 2 diabetes. Methods: This double-blind randomized clinical trial was carried out on 72 women for 10 weeks. Subjects were assigned to quercetin and placebo groups using a permutated block randomization of size two. Quercetin was given to participants as a 500 mg capsule daily. Biochemical variables were measured at baseline and at the end of the study, and changes were compared using appropriate statistical methods. Results: Compared with placebo, quercetin intake decreased systolic blood pressure significantly (−8.8 ± 9.3 vs. −3.5 ± 11.7, P = 0.04. Although changes in diastolic blood pressure between the groups was not significant ( P = 0.19, high-density lipoprotein cholesterol (HDL-C was significantly decreased in both groups while changes in total cholesterol, low-density lipoprotein cholesterol (LDL-C, triglycerides (TG and ratio of TG/HDL-C and LDL-C/HDL-C were not significant between and within groups. Quercetin supplementation significantly reduced the serum concentration of tumor necrosis factor-α (TNF-α and interleukin-6 (IL-6 ( P = 0.01 and P < 0.0001, respectively; however, the mean changes in serum levels of IL-6, TNF-α, and high-sensitivity C-reactive protein were not significant between the groups. Conclusions: Quercetin supplementation reduced systolic blood pressure significantly but had no effect on other cardiovascular risk factors and inflammatory biomarkers. Considering the biological effects of quercetin in vitro, we need more studies with a stronger design and sample size with different doses of quercetin.

  5. Effects of a New Flavonoid and Myo-Inositol Supplement on Some Biomarkers of Cardiovascular Risk in Postmenopausal Women: A Randomized Trial

    Directory of Open Access Journals (Sweden)

    Rosario D’Anna

    2014-01-01

    Full Text Available Background and Aim. Cardiovascular risk is increased in women with menopause and metabolic syndrome. Aim of this study was to test the effect of a new supplement formula, combining cocoa polyphenols, myo-inositol, and soy isoflavones, on some biomarkers of cardiovascular risk in postmenopausal women with metabolic syndrome. Methods and Results. A total of 60 women were enrolled and randomly assigned (n=30 per group to receive the supplement (NRT: 30 mg of cocoa polyphenols, 80 mg of soy isoflavones, and 2 gr of myo-inositol, or placebo for 6 months. The study protocol included three visits (baseline, 6, and 12 months for the evaluation of glucose, triglycerides, and HDL-cholesterol (HDL-C, adiponectin, visfatin, resistin, and bone-specific alkaline phosphatase (bone-ALP. At 6 months, a significant difference between NRT and placebo was found for glucose (96±7 versus 108±10 mg/dL, triglycerides (145±14 versus 165±18 mg/dL, visfatin (2.8±0.8 versus 3.7±1.1 ng/mL, resistin (27±7 versus 32±8 µg/L, and b-ALP (19±7 versus 15±5 µg/mL. No difference in HDL-C concentrations nor in adiponectin levels between groups was reported at 6 months. Conclusions. The supplement used in this study improves most of the biomarkers linked to metabolic syndrome. This Trial is registered with NCT01400724.

  6. LEADER 5: prevalence and cardiometabolic impact of obesity in cardiovascular high-risk patients with type 2 diabetes mellitus: baseline global data from the LEADER trial.

    Science.gov (United States)

    Masmiquel, L; Leiter, L A; Vidal, J; Bain, S; Petrie, J; Franek, E; Raz, I; Comlekci, A; Jacob, S; van Gaal, L; Baeres, F M M; Marso, S P; Eriksson, M

    2016-02-10

    Epidemiological data on obesity are needed, particularly in patients with type 2 diabetes mellitus (T2DM) and high cardiovascular (CV) risk. We used the baseline data of liraglutide effect and action in diabetes: evaluation of CV outcome results-A long term Evaluation (LEADER) (a clinical trial to assess the CV safety of liraglutide) to investigate: (i) prevalence of overweight and obesity; (ii) relationship of the major cardiometabolic risk factors with anthropometric measures of adiposity [body mass index (BMI) and waist circumference (WC)]; and (iii) cardiometabolic treatment intensity in relation to BMI and WC. LEADER enrolled two distinct populations of high-risk patients with T2DM in 32 countries: (1) aged ≥50 years with prior CV disease; (2) aged ≥60 years with one or more CV risk factors. Associations of metabolic variables, demographic variables and treatment intensity with anthropometric measurements (BMI and WC) were explored using regression models (ClinicalTrials.gov identifier: NCT01179048). Mean BMI was 32.5 ± 6.3 kg/m(2) and only 9.1 % had BMI prevalence of healthy WC was also extremely low (6.4 % according to International Joint Interim Statement for the Harmonization of the Metabolic Syndrome criteria). Obesity was associated with being younger, female, previous smoker, Caucasian, American, with shorter diabetes duration, uncontrolled blood pressure (BP), antihypertensive agents, insulin plus oral antihyperglycaemic treatment, higher levels of triglycerides and lower levels of high-density lipoprotein cholesterol. Overweight and obesity are prevalent in high CV risk patients with T2DM. BMI and WC are related to the major cardiometabolic risk factors. Furthermore, treatment intensity, such as insulin, statins or oral antihypertensive drugs, is higher in those who are overweight or obese; while BP and lipid control in these patients are remarkably suboptimal. LEADER confers a unique opportunity to explore the longitudinal effect of weight on CV

  7. WHAT CAN WE EXPECT USING ACE INHIBITOR RAMIPRIL IN PERSONS WITH HIGH CARDIOVASCULAR RISK AND EARLY DISORDERS OF CARBOHYDRATE METABOLISM? LESSONS OF DREAM TRIAL

    Directory of Open Access Journals (Sweden)

    M. N. Mamedov

    2008-01-01

    Full Text Available Primary prevention of diabetes in persons with high cardiovascular risk is an actual problem. Results of DREAM trial are discussed. Influence of ACE inhibitor, ramipril, on risk of diabetes onset in patients with pre-diabetes and low cardiovascular risk is focused. Metabolic effects of other groups of antihypertensive drugs and their ability to prevent diabetes onset are compared. Ramipril three years therapy resulted in normalization in glucose level but did not have effect on frequency of diabetes onset. Change in life-style and regular usage of ACE inhibitor, ramipril, can contribute in normalization of glycemia level in patients with combination of pre-diabetes and arterial hypertension.

  8. Evaluation of cardiovascular toxicity of carbon nanotubes functionalized with sodium hyaluronate in oral regenerative medicine

    Energy Technology Data Exchange (ETDEWEB)

    Joviano-Santos, J.V.; Sá, M.A.; De Maria, M.L.A.; Almeida, T.C.S. [Departamento de Morfologia, Universidade Federal de Minas Gerais, Belo Horizonte, MG (Brazil); Geraldo, V.; Oliveira, S.; Ladeira, L.O. [Departamento de Física, Universidade Federal de Minas Gerais, Belo Horizonte, MG (Brazil); Ferreira, A.J. [Departamento de Morfologia, Universidade Federal de Minas Gerais, Belo Horizonte, MG (Brazil)

    2014-05-23

    It has been demonstrated that carbon nanotubes (CNTs) associated with sodium hyaluronate (HY-CNTs) accelerate bone repair in the tooth sockets of rats. Before clinical application of HY-CNTs, it is important to assess their biocompatibility. Moreover, cardiac toxicity may be caused by the translocation of these particles to the blood stream. The aim of this study was to evaluate possible changes in cardiovascular function in male Wistar rats whose tooth sockets were treated with either CNTs or HY-CNTs (100 μg/mL, 0.1 mL). Blood pressure and heart rate were monitored in conscious rats 7 days after treatment. Cardiac function was evaluated using the Langendorff perfusion technique. The data showed no changes in blood pressure or heart rate in rats treated with either CNTs or HY-CNTs, and no significant changes in cardiac function were found in any of the groups. To confirm these findings, experiments were conducted in rats injected intraperitoneally with a high concentration of either CNTs or HY-CNTs (0.75 mg/kg). The same parameters were analyzed and similar results were observed. The results obtained 7 days following injection indicate that the administration of low concentrations of CNTs or HY-CNTs directly into tooth sockets did not cause any significant change in cardiovascular function in the rats. The present findings support the possibility of using these biocomposites in humans.

  9. Cross-system evaluation of clinical trial search engines.

    Science.gov (United States)

    Jiang, Silis Y; Weng, Chunhua

    2014-01-01

    Clinical trials are fundamental to the advancement of medicine but constantly face recruitment difficulties. Various clinical trial search engines have been designed to help health consumers identify trials for which they may be eligible. Unfortunately, knowledge of the usefulness and usability of their designs remains scarce. In this study, we used mixed methods, including time-motion analysis, think-aloud protocol, and survey, to evaluate five popular clinical trial search engines with 11 users. Differences in user preferences and time spent on each system were observed and correlated with user characteristics. In general, searching for applicable trials using these systems is a cognitively demanding task. Our results show that user perceptions of these systems are multifactorial. The survey indicated eTACTS being the generally preferred system, but this finding did not persist among all mixed methods. This study confirms the value of mixed-methods for a comprehensive system evaluation. Future system designers must be aware that different users groups expect different functionalities.

  10. Cardiovascular and inflammatory effects of simvastatin therapy in patients with COPD: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    John ME

    2015-01-01

    Full Text Available Michelle E John,1 John R Cockcroft,2 Tricia M McKeever,3 William R Coward,1 Dennis J Shale,2 Simon R Johnson,1 Jim G Thornton,4 Timothy W Harrison,1 Alan J Knox,1 Charlotte E Bolton1 1Nottingham Respiratory Research Unit, School of Medicine, University of Nottingham, Nottingham, UK; 2Wales Heart Research Institute, Cardiff University, Cardiff, UK; 3Division of Epidemiology and Public Health, 4Clinical Trials Unit and Department of Obstetrics and Gynaecology, School of Medicine, University of Nottingham, Nottingham, UK Background: There is excess cardiovascular mortality in patients with chronic obstructive pulmonary disease. Aortic stiffness, an independent predictor of cardiovascular risk, and systemic and airway inflammation are increased in patients with the disease. Statins modulate aortic stiffness and have anti-inflammatory properties. A proof-of-principle, double-blind, randomized trial determined if 6 weeks of simvastatin 20 mg once daily reduced aortic stiffness and systemic and airway inflammation in patients with chronic obstructive pulmonary disease.Methods: Stable patients (n=70 were randomized to simvastatin (active or placebo. Pre-treatment and post-treatment aortic stiffness, blood pressure, spirometry, and circulating and airway inflammatory mediators and lipids were measured. A predefined subgroup analysis was performed where baseline aortic pulse wave velocity (PWV was >10 m/sec.Results: Total cholesterol dropped in the active group. There was no significant change in aortic PWV between the active group and the placebo group (-0.7 m/sec, P=0.24. In those with aortic stiffness >10 m/sec (n=22, aortic PWV improved in the active group compared with the placebo group (-2.8 m/sec, P=0.03. Neither systemic nor airway inflammatory markers changed. Conclusion: There was a nonsignificant improvement in aortic PWV in those taking simvastatin 20 mg compared with placebo, but in those with higher baseline aortic stiffness (a higher risk

  11. A cluster-randomised clinical trial comparing two cardiovascular health education strategies in a child population: the Savinghearts project

    Directory of Open Access Journals (Sweden)

    Sánchez-Gómez Luis

    2012-11-01

    Full Text Available Abstract Background This paper describes a methodology for comparing the effects of an eduentertainment strategy involving a music concert, and a participatory class experience involving the description and making of a healthy breakfast, as educational vehicles for delivering obesity-preventing/cardiovascular health messages to children aged 7–8 years. Methods/design This study will involve a cluster-randomised trial with blinded assessment. The study subjects will be children aged 7–8 years of both sexes attending public primary schools in the Madrid Region. The participating schools (n=30 will be randomly assigned to one of two groups: 1 Group MC, in which the children will attend a music concert that delivers obesity-preventing/cardiovascular health messages, or 2 Group HB, in which the children will attend a participatory class providing the same information but involving the description and making of a healthy breakfast. The main outcome measured will be the increase in the number of correct answers scored on a knowledge questionnaire and in an attitudes test administered before and after the above interventions. The secondary outcome recorded will be the reduction in BMI percentile among children deemed overweight/obese prior to the interventions. The required sample size (number of children was calculated for a comparison of proportions with an α of 0.05 and a β of 0.20, assuming that the Group MC subjects would show values for the measured variables at least 10% higher than those recorded for the subjects of Group HB. Corrections were made for the design effect and assuming a loss to follow-up of 10%. The maximum sample size required will be 2107 children. Data will be analysed using summary measurements for each cluster, both for making estimates and for hypothesis testing. All analyses will be made on an intention-to-treat basis. Discussion The intervention providing the best results could be recommended as part of health

  12. An initial reduction in serum uric acid during angiotensin receptor blocker treatment is associated with cardiovascular protection: a post-hoc analysis of the RENAAL and IDNT trials.

    Science.gov (United States)

    Smink, Paul A; Bakker, Stephan J L; Laverman, Gozewijn D; Berl, Tomas; Cooper, Mark E; de Zeeuw, Dick; Lambers Heerspink, Hiddo J

    2012-05-01

    Increased levels of serum uric acid (SUA) are thought to be an independent risk marker for cardiovascular complications. Treatment with the angiotensin receptor blocker (ARB) losartan lowers SUA in contrast to other ARBs. Whether reductions in SUA during ARB therapy are associated with cardiovascular protection is unclear. We aimed to investigate this. In a post-hoc analysis of the Reduction of Endpoints in Non insulin dependent diabetes mellitus with the Angiotensin II Antagonist Losartan (RENAAL) and Irbesartan Diabetic Nephropathy (IDNT) trials we determined whether the short-term effect of losartan and of irbesartan on SUA is related with long-term cardiovascular outcome by means of Cox regression. Compared to placebo, losartan significantly changed SUA [-0.16  mg/dl; 95% confidence interval (CI) -0.01 to -0.30; P = 0.031], whereas irbesartan did not (-0.09  mg/dl; (95% CI 0.09 to -0.28; P = 0.30). Each 0.5  mg/dl decrement in SUA during losartan treatment in the first 6 months resulted in a reduction in the risk of cardiovascular outcomes by 5.3% (95% CI 0.9 to 9.9; P = 0.017). Losartan reduced the risk of cardiovascular outcomes by 9.2% (95% CI -7.9 to 23.6). Adjustment for the 6-month change in SUA attenuated the treatment effect to 4.6% (95% CI -16.2 to 22.0), suggesting that part of the cardiovascular protective effect of losartan is attributable to its short-term effect on SUA. Losartan but not irbesartan significantly lowers SUA compared to placebo in patients with type 2 diabetes and nephropathy. The degree of reduction in SUA explains part of the cardiovascular effect of losartan. This supports the hypothesis that SUA is a modifiable risk factor for cardiovascular disease, at least in type 2 diabetics with nephropathy.

  13. Plasma triglycerides and cardiovascular events in the Treating to New Targets and Incremental Decrease in End-Points through Aggressive Lipid Lowering trials of statins in patients with coronary artery disease

    DEFF Research Database (Denmark)

    Faergeman, Ole; Holme, Ingar; Fayyad, Rana

    2009-01-01

    We determined the ability of in-trial measurements of triglycerides (TGs) to predict new cardiovascular events (CVEs) using data from the Incremental Decrease in End Points through Aggressive Lipid Lowering (IDEAL) and Treating to New Targets (TNT) trials. The trials compared atorvastatin 80 mg...... adjusting for age, gender, and study, risk of CVEs increased with increasing TGs (p relation of TGs...

  14. Effect of Muscadine Grape Seed Supplementation on Vascular Function in Subjects with or at Risk for Cardiovascular Disease: A Randomized Crossover Trial

    Science.gov (United States)

    Mellen, Philip B.; Daniel, Kurt R.; Brosnihan, K. Bridget; Hansen, Kim J.; Herrington, David M.

    2012-01-01

    Background Muscadine grape seeds have high concentrations of polyphenolic compounds with antioxidant and other properties that would be expected to have favorable effects on endothelial function. Objectives To evaluate the effect of muscadine grape seed supplementation on endothelial function and cardiovascular risk factors in subjects with increased cardiovascular risk. Design In a randomized, double-blind, placebo-controlled crossover trial, 50 adults with coronary disease or ≥1 cardiac risk factor received muscadine grape seed supplementation (1300 mg daily) and placebo for 4 weeks each, with a 4-week washout. Resting brachial diameter and brachial flow-mediated dilation (FMD) and biomarkers of inflammation, lipid peroxidation, and antioxidant capacity were determined at the beginning and end of each period and compared in mixed linear models. Results There was no evidence of improved FMD (% change) with muscadine grape seed (muscadine grape seed: pre 5.2% ± 0.3%, post 4.6% ± 0.3%, p = 0.06; placebo: pre 5.3% ± 0.4%, post 5.2% ± 0.4%, p = 0.82; p for muscadine grape seed vs. placebo = 0.25). However, there was a significant increase in baseline diameter (mm) with muscadine grape seed supplementation (muscadine grape seed: pre 4.05 ± 0.09, post 4.23 ± 0.10, p = 0.002; placebo: pre 4.12 ± 0.11, post 4.12 ± 0.10, p = 0.93; p for muscadine grape seed vs. placebo = 0.026). All other biomarkers were not significantly altered by muscadine grape seed supplementation. Conclusions Four weeks of muscadine grape seed supplementation in subjects with increased cardiovascular risk did not produce a statistically significant increase in brachial flow-mediated vasodilation or a significant change in other biomarkers of inflammation, lipid peroxidation, or antioxidant capacity. However, the muscadine grape seed supplement did result in a significant increase in resting brachial diameter. The clinical significance of the effect on resting diameter is not yet established

  15. Report of the European Society of Cardiology Cardiovascular Round Table regulatory workshop update of the evaluation of new agents for the treatment of acute coronary syndrome: Executive summary.

    Science.gov (United States)

    Bueno, Héctor; de Graeff, Pieter; Richard-Lordereau, Isabelle; Emmerich, Joseph; Fox, Keith Aa; Friedman, Carola P; Gaudin, Christophe; El-Gazayerly, Amany; Goldman, Samantha; Hemmrich, Melanie; Henderson, Robert A; Himmelmann, Anders; Irs, Alar; Jackson, Neville; James, Stefan K; Katus, Hugo A; Laslop, Andrea; Laws, Ian; Mehran, Roxana; Ong, Seleen; Prasad, Krishna; Roffi, Marco; Rosano, Giuseppe Mc; Rose, Martin; Sinnaeve, Peter R; Stough, Wendy Gattis; Thygesen, Kristian; Van de Werf, Frans; Varin, Claire; Verheugt, Freek Wa; de Los Angeles Alonso García, Maria

    2016-06-29

    Regulatory authorities interpret the results of randomized controlled trials according to published principles. The European Medicines Agency (EMA) is planning a revision of the 2000 and 2003 guidance documents on clinical investigation of new medicinal products for the treatment of acute coronary syndrome (ACS) to achieve consistency with current knowledge in the field. This manuscript summarizes the key output from a collaborative workshop, organized by the Cardiovascular Round Table and the European Affairs Committee of the European Society of Cardiology, involving clinicians, academic researchers, trialists, European and US regulators, and pharmaceutical industry researchers. Specific questions in four key areas were selected as priorities for changes in regulatory guidance: patient selection, endpoints, methodologic issues and issues related to the research for novel agents. Patients with ST-segment elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI) should be studied separately for therapies aimed at the specific pathophysiology of either condition, particularly for treatment of the acute phase, but can be studied together for other treatments, especially long-term therapy. Unstable angina patients should be excluded from acute phase ACS trials. In general, cardiovascular death and reinfarction are recommended for primary efficacy endpoints; other endpoints may be considered if specifically relevant for the therapy under study. New agents or interventions should be tested against a background of evidence-based therapy with expanded follow-up for safety assessment. In conclusion, new guidance documents for randomized controlled trials in ACS should consider changes regarding patient and endpoint selection and definitions, and trial designs. Specific requirements for the evaluation of novel pharmacological therapies need further clarification. © The European Society of Cardiology 2016.

  16. Evaluation of cardiovascular risk in patients with Parkinson disease under levodopa treatment.

    Science.gov (United States)

    Günaydın, Zeki Yüksel; Özer, Fahriye Feriha; Karagöz, Ahmet; Bektaş, Osman; Karataş, Mehmet Baran; Vural, Aslı; Bayramoğlu, Adil; Çelik, Abdullah; Yaman, Mehmet

    2016-01-01

    Levodopa is the indispensable choice of medial therapy in patients with Parkinson disease (PD). Since L-dopa treatment was shown to increase serum homocysteine levels, a well-known risk factor for cardiovascular disorders, the patients with PD under L-dopa treatment will be at increased risk for future cardiovascular events. The objective of this study is to evaluate cardiovascular risk in patients with PD under levodopa treatment. The study population consisted of 65 patients with idiopathic PD under L-dopa treatment. The control group included 32 age and gender matched individuals who had no cognitive decline. Echocardiographic measurements, serum homocysteine levels and elastic parameters of the aorta were compared between the patients with PD and controls. As an expected feature of L-dopa therapy, the Parkinson group had significantly higher homocystein levels (15.1 ± 3.9 µmol/L vs. 11.5 ± 3.2 µmol/L, P = 0.02). Aortic distensibility was significantly lower in the patients with PD when compared to controls (4.8 ± 1.5 dyn/cm(2) vs. 6.2 ± 1.9 dyn/cm(2), P = 0.016). Additionally, the patients with PD had higher aortic strain and aortic stiffness index (13.4% ± 6.4% vs. 7.4% ± 3.6%, P homocysteine levels were found to be positively correlated with aortic stiffness index and there was a negative correlation between aortic distensibility and levels of serum homocysteine (r = 0.674, P homocysteine levels may be a possible pathophysiological mechanism.

  17. Adding pharmacists to primary care teams reduces predicted long-term risk of cardiovascular events in type 2 diabetic patients without established cardiovascular disease: results from a randomized trial.

    Science.gov (United States)

    Ladhani, N N; Majumdar, S R; Johnson, J A; Tsuyuki, R T; Lewanczuk, R Z; Spooner, R; Simpson, S H

    2012-11-01

    To determine the impact of adding pharmacists to primary care teams on predicted 10-year risk of cardiovascular events in patients with Type 2 diabetes without established cardiovascular disease. This was a pre-specified secondary analysis of randomized trial data. The main study found that, compared with usual care, addition of a pharmacist resulted in improvements in blood pressure, dyslipidaemia, and hyperglycaemia for primary care patients with Type 2 diabetes. In this sub-study, predicted 10-year risk of cardiovascular events at baseline and 1 year were calculated for patients free of cardiovascular disease at enrolment. The primary outcome was change in UK Prospective Diabetes Study (UKPDS) risk score; change in Framingham risk score was a secondary outcome. Baseline characteristics were similar between the 102 intervention patients and 93 control subjects: 59% women, median (interquartile range) age 57 (50-64) years, diabetes duration 3 (1-6.5) years, systolic blood pressure 128 (120-140) mmHg, total cholesterol 4.34 (3.75-5.04) mmol/l and HbA(1c) 54 mmol/mol (48-64 mmol/mol) [7.1% (6.5-8.0%)]. Median baseline UKPDS risk score was 10.2% (6.0-16.7%) for intervention patients and 9.5% (5.8-15.1%) for control subjects (P = 0.80). One-year post-randomization, the median absolute reduction in UKPDS risk score was 1.0% greater for intervention patients compared with control subjects (P = 0.032). Similar changes were seen with the Framingham risk score (median reduction 1.2% greater for intervention patients compared with control subjects, P = 0.048). The two risk scores were highly correlated (rho = 0.83; P risk of cardiovascular events for patients with Type 2 diabetes without established cardiovascular disease. © 2012 The Authors. Diabetic Medicine © 2012 Diabetes UK.

  18. The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records: evaluations of two exemplar trials.

    Science.gov (United States)

    van Staa, Tjeerd-Pieter; Dyson, Lisa; McCann, Gerard; Padmanabhan, Shivani; Belatri, Rabah; Goldacre, Ben; Cassell, Jackie; Pirmohamed, Munir; Torgerson, David; Ronaldson, Sarah; Adamson, Joy; Taweel, Adel; Delaney, Brendan; Mahmood, Samhar; Baracaia, Simona; Round, Thomas; Fox, Robin; Hunter, Tommy; Gulliford, Martin; Smeeth, Liam

    2014-07-01

    Pragmatic trials compare the effects of different decisions in usual clinical practice. To develop and evaluate methods to implement simple pragmatic trials using routinely collected electronic health records (EHRs) and recruiting patients at the point of care; to identify the barriers and facilitators for general practitioners (GPs) and patients and the experiences of trial participants. Two exemplar randomised trials (Retropro and eLung) with qualitative evaluations. Four hundred and fifty-nine English and Scottish general practices contributing EHRs to a research database, of which 17 participated in the trials. Retropro aimed to recruit 300 patients with hypercholesterolaemia and high cardiovascular risk and eLung aimed to recruit 150 patients with a chronic obstructive pulmonary disease exacerbation. Retropro randomised between simvastatin and atorvastatin and eLung between immediate antibiotics and deferred or non-use. eLung recruited during an unscheduled consultation using EHR flagging. Successful trial completion with implementation of information technology (IT) system for flagging and data processing and documentation of operational and scientific experiences. EHR research database. The governance approval process took over 3 years. A total of 58.8% of the practices (n = 270) expressed interest in participating. The number of interested practices dropped substantially with each stage of the governance process. In Retropro, 6.5% of the practices (n = 30) were eventually approved and 3.7% (n = 17) recruited patients; in eLung, these numbers were 6.8% (n = 31) and 1.3% (n = 6) respectively. Retropro successfully completed recruitment (301 patients) whereas eLung recruited 31 patients. Retropro recruited 20.6% of all statin starters in recruiting practices and 1.1% in the EHR database; the comparable numbers for eLung were 32.3% and 0.9% respectively. The IT system allowed for complex eligibility criteria with central on and off control

  19. Erectile dysfunction in type 2 diabetic men: relationship to exercise fitness and cardiovascular risk factors in the Look AHEAD trial.

    Science.gov (United States)

    Rosen, Raymond C; Wing, Rena R; Schneider, Stephen; Wadden, Thomas A; Foster, Gary D; West, Delia Smith; Kitabchi, Abbas E; Brancati, Frederick L; Maschak-Carey, Barbara J; Bahnson, Judy L; Lewis, Cora E; Gendrano Iii, Isaias N

    2009-05-01

    Determinants of erectile dysfunction in diabetic men have not been adequately investigated as potential mediators of change. To determine the prevalence and correlates of erectile dysfunction (ED) in overweight men with type 2 diabetes in the multicenter, Look AHEAD trial (Action for Health in Diabetes). International Index of Erectile Function (IIEF), self-reported use of phosphodiesterase type 5 inhibitors, laboratory measures of adiposity, cardiometabolic parameters, and exercise fitness. Male participants aged 45-75 in the Look AHEAD trial in a committed relationship were recruited for an ongoing study of sexual function and diabetes. Eligible participants completed the IIEF questionnaire and provided updated information on use of medical treatments for sexual dysfunction. Baseline sexual function results for participants in the male ancillary study are reported here; intervention data and results for female participants are presented elsewhere. A total of 373 eligible male participants completed all sexual function questionnaires, of whom 263 (68.7%) were sexually active at the time of the study. Almost half (49.8%) of the men reported mild or moderate degrees of ED, and 24.8% had complete ED. Among sexually active participants, 42.6% had sought medical help for their problem, and 39.7% reported use of ED medications. ED was significantly associated with age (odds ratio [OR] = 1.05; confidence interval [CI]: 1.01-1.10) baseline HbA(1c) (OR = 1.31; CI: 1.05-1.63), hypertension history (OR = 2.41; CI: 1.34-4.36), and metabolic syndrome (OR = 3.05, CI: 1.31-7.11). Of note, cardiorespiratory fitness was found to be protective of ED in a multivariable analysis (OR = 0.61; P type 2 diabetic men in the Look AHEAD study. Cardiovascular risk factors were highly associated with ED in this population, and cardiorespiratory fitness was protective in this analysis.

  20. Effects of chocolate, cocoa, and flavan-3-ols on cardiovascular health: a systematic review and meta-analysis of randomized trials.

    Science.gov (United States)

    Hooper, Lee; Kay, Colin; Abdelhamid, Asmaa; Kroon, Paul A; Cohn, Jeffrey S; Rimm, Eric B; Cassidy, Aedín

    2012-03-01

    There is substantial interest in chocolate and flavan-3-ols for the prevention of cardiovascular disease (CVD). The objective was to systematically review the effects of chocolate, cocoa, and flavan-3-ols on major CVD risk factors. We searched Medline, EMBASE, and Cochrane databases for randomized controlled trials (RCTs) of chocolate, cocoa, or flavan-3-ols. We contacted authors for additional data and conducted duplicate assessment of study inclusion, data extraction, validity, and random-effects meta-analyses. We included 42 acute or short-term chronic (≤18 wk) RCTs that comprised 1297 participants. Insulin resistance (HOMA-IR: -0.67; 95% CI: -0.98, -0.36) was improved by chocolate or cocoa due to significant reductions in serum insulin. Flow-mediated dilatation (FMD) improved after chronic (1.34%; 95% CI: 1.00%, 1.68%) and acute (3.19%; 95% CI: 2.04%, 4.33%) intakes. Effects on HOMA-IR and FMD remained stable to sensitivity analyses. We observed reductions in diastolic blood pressure (BP; -1.60 mm Hg; 95% CI: -2.77, -0.43 mm Hg) and mean arterial pressure (-1.64 mm Hg; 95% CI: -3.27, -0.01 mm Hg) and marginally significant effects on LDL (-0.07 mmol/L; 95% CI: -0.13, 0.00 mmol/L) and HDL (0.03 mmol/L; 95% CI: 0.00, 0.06 mmol/L) cholesterol. Chocolate or cocoa improved FMD regardless of the dose consumed, whereas doses >50 mg epicatechin/d resulted in greater effects on systolic and diastolic BP. GRADE (Grading of Recommendations, Assessment, Development and Evaluation, a tool to assess quality of evidence and strength of recommendations) suggested low- to moderate-quality evidence of beneficial effects, with no suggestion of negative effects. The strength of evidence was lowered due to unclear reporting for allocation concealment, dropouts, missing data on outcomes, and heterogeneity in biomarker results in some studies. We found consistent acute and chronic benefits of chocolate or cocoa on FMD and previously unreported promising effects on insulin and HOMA

  1. Human Cardiovascular Disease IBC Chip-Wide Association with Weight Loss and Weight Regain in the Look AHEAD Trial

    Science.gov (United States)

    McCaffery, Jeanne M.; Papandonatos, George D.; Huggins, Gordon S.; Peter, Inga; Erar, Bahar; Kahn, Steven E.; Knowler, William C.; Lipkin, Edward W.; Kitabchi, Abbas E.; Wagenknecht, Lynne E.; Wing, Rena R.

    2014-01-01

    Background/Aims The present study identified genetic predictors of weight change during behavioral weight loss treatment. Methods Participants were 3,899 overweight/obese individuals with type 2 diabetes from Look AHEAD, a randomized controlled trial to determine the effects of intensive lifestyle intervention (ILI), including weight loss and physical activity, relative to diabetes support and education, on cardiovascular outcomes. Analyses focused on associations of single nucleotide polymorphisms (SNPs) on the Illumina CARe iSelect (IBC) chip (minor allele frequency >5%; n = 31,959) with weight change at year 1 and year 4, and weight regain at year 4, among individuals who lost ≥ 3% at year 1. Results Two novel regions of significant chip-wide association with year-1 weight loss in ILI were identified (p < 2.96E-06). ABCB11 rs484066 was associated with 1.16 kg higher weight per minor allele at year 1, whereas TNFRSF11A, or RANK, rs17069904 was associated with 1.70 kg lower weight per allele at year 1. Conclusions This study, the largest to date on genetic predictors of weight loss and regain, indicates that SNPs within ABCB11, related to bile salt transfer, and TNFRSF11A, implicated in adipose tissue physiology, predict the magnitude of weight loss during behavioral intervention. These results provide new insights into potential biological mechanisms and may ultimately inform weight loss treatment. PMID:24081232

  2. Effects of matched weight loss from calorie restriction, exercise, or both on cardiovascular disease risk factors: a randomized intervention trial.

    Science.gov (United States)

    Weiss, Edward P; Albert, Stewart G; Reeds, Dominic N; Kress, Kathleen S; McDaniel, Jennifer L; Klein, Samuel; Villareal, Dennis T

    2016-09-01

    Weight loss from calorie restriction (CR) and/or endurance exercise training (EX) is cardioprotective. However CR and EX also have weight loss-independent benefits. We tested the hypothesis that weight loss from calorie restriction and exercise combined (CREX) improves cardiovascular disease (CVD) risk factors more so than similar weight loss from CR or EX alone. Overweight, sedentary men and women (n = 52; aged 45-65 y) were randomly assigned to undergo 6-8% weight loss by using CR, EX, or CREX. Outcomes were measured before and after weight loss and included maximal oxygen consumption (VO2max), resting blood pressure, fasting plasma lipids, glucose, C-reactive protein, and arterial stiffness [carotid-femoral pulse wave velocity (PWV) and carotid augmentation index (AI)]. Values are means ± SEs. Reductions in body weight (∼7%) were similar in all groups. VO2max changed in proportion to the amount of exercise performed (CR, -1% ± 3%; EX, +22% ± 3%; and CREX, +11% ± 3%). None of the changes in CVD risk factors differed between groups. For all groups combined, decreases were observed for systolic and diastolic blood pressure (-5 ± 1 and -4 ± 1 mm Hg, respectively; both P weight losses from CR, EX, and CREX have substantial beneficial effects on CVD risk factors. However, the effects are not additive when weight loss is matched. This trial was registered at clinicaltrials.gov as NCT00777621. © 2016 American Society for Nutrition.

  3. No significant improvement of cardiovascular disease risk indicators by a lifestyle intervention in people with Familial Hypercholesterolemia compared to usual care: results of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Broekhuizen Karen

    2012-07-01

    Full Text Available Abstract Background People with Familial Hypercholesterolemia (FH may benefit from lifestyle changes supporting their primary treatment of dyslipidaemia. This project evaluated the efficacy of an individualised tailored lifestyle intervention on lipids (low density lipoprotein cholesterol (LDL-C, high density lipoprotein cholesterol (HDL-C, total cholesterol (TC and triglycerides, systolic blood pressure, glucose, body mass index (BMI and waist circumference in people with FH. Methods Adults with FH (n = 340, recruited from a Dutch cascade screening program, were randomly assigned to either a control group or an intervention group. The personalised intervention consisted of web-based tailored lifestyle advice and personal counselling. The control group received care as usual. Lipids, systolic blood pressure, glucose, BMI, and waist circumference were measured at baseline and after 12 months. Regression analyses were conducted to examine differences between both groups. Results After 12 months, no significant between-group differences of cardiovascular disease (CVD risk indicators were observed. LDL-C levels had decreased in both the intervention and control group. This difference between intervention and control group was not statistically significant. Conclusions This project suggests that an individually tailored lifestyle intervention did not have an additional effect in improving CVD risk indicators among people with FH. The cumulative effect of many small improvements in all indicators on long term CVD risk remains to be assessed in future studies. Trial registration NTR1899 at ww.trialregister.nl

  4. Drop-out from cardiovascular magnetic resonance in a randomized controlled trial of ST-elevation myocardial infarction does not cause selection bias on endpoints

    DEFF Research Database (Denmark)

    Laursen, Peter Nørkjær; Holmvang, L.; Kelbæk, H.

    2017-01-01

    Background: The extent of selection bias due to drop-out in clinical trials of ST-elevation myocardial infarction (STEMI) using cardiovascular magnetic resonance (CMR) as surrogate endpoints is unknown. We sought to interrogate the characteristics and prognosis of patients who dropped out before...... as evaluated by the TIMI-risk score (3.7 (± 2.1) vs 4.0 (± 2.6), p = 0.043) and by left ventricular ejection fraction (43 (± 9) vs. 47 (± 10), p = 0.029). CMR drop-outs had a higher incidence of known hypertension (39% vs. 35%, p = 0.043), known diabetes (14% vs. 7%, p = 0.025), known cardiac disease (11% vs....... 3%, p = 0.013) and known renal function disease (5% vs. 0%, p = 0.007). However, the 30-day and 5-years composite endpoint rate was not significantly higher among the CMR drop-out ((HR 1.43 (95%-CI 0.5; 3.97) (p = 0.5)) and (HR 1.31 (95%-CI 0.84; 2.05) (p = 0.24)). Conclusion: CMR-drop-outs had...

  5. Using Concurrent Cardiovascular Information to Augment Survival Time Data for Evaluating Orthostatic Tilt Test Performance

    Science.gov (United States)

    Feiveson, Alan H.; Fiedler, James; Lee, Stuart M. C.; Koslovsky, Matthew D.; Stenger, Michael B.; Platts, Steven H.

    2018-01-01

    Head-up tilt (HUT) tests often are used in research to measure orthostatic intolerance (OI) (inability to appropriately control blood pressure while upright) in clinical populations and otherwise healthy individuals after interventions. Post-space flight orthostatic intolerance is a well-known phenomenon, and countermeasures to its development has been an active area of research at NASA. In the NASA HUT protocol, subjects lie horizontally on an automatic tilt table for baseline measurements before being raised to 80deg head-up tilt for a defined period of time or until signs or symptoms of presyncope ensues (light-headedness, nausea, dizziness, sweating, weakness or fainting). Multiple measures are collected to evaluate the cardiovascular system's ability to respond appropriately to the orthostatic challenge. However if the intended duration of the HUT is short, the ability to detect changes in OI due to an intervention or its prevention by a countermeasure may be limited by a small number of failures to permit comparisons based on survival time alone. Thus, the time-trajectory of the cardiovascular data becomes an important additional source of information. In particular, we will show how various measures of trajectory variability can effectively augment survival analysis for the assessment of OI in a joint model when high censoring rates are present.

  6. HDL cholesterol and residual risk of first cardiovascular events after treatment with potent statin therapy: an analysis from the JUPITER trial

    DEFF Research Database (Denmark)

    Ridker, P.M.; Genest, J.; Boekholdt, S.M.

    2010-01-01

    Background HDL-cholesterol concentrations are inversely associated with occurrence of cardiovascular events. We addressed, using the JUPITER trial cohort, whether this association remains when LDL-cholesterol concentrations are reduced to the very low ranges with high-dose statin treatment. Methods...... Participants in the randomised placebo-controlled JUPITER trial were adults without diabetes or previous cardiovascular disease, and had baseline concentrations of LDL cholesterol of less than 3.37 mmol/L and high-sensitivity C-reactive protein of 2 mg/L or more. Participants were randomly allocated...... by a computer-generated sequence to receive rosuvastatin 20 mg per day or placebo, with participants and adjudicators masked to treatment assignment. In the present analysis, we divided the participants into quartiles of HDL-cholesterol or apolipoprotein A1 and sought evidence of association between...

  7. Cardiovascular safety of empagliflozin in patients with type 2 diabetes: a meta?analysis of data from randomized placebo?controlled trials

    OpenAIRE

    Salsali, A.; Kim, G.; Woerle, H. J.; Broedl, U. C.; Hantel, S.

    2016-01-01

    Aim To assess the effect of empagliflozin on cardiovascular (CV) risk in patients with type 2 diabetes (T2DM) through a meta?analysis of data from eight placebo?controlled trials. Methods Data were analysed from eight randomized placebo?controlled trials undertaken to investigate the efficacy and safety of empagliflozin 10 and 25?mg once daily in patients with T2DM, comprising patients at low/medium and high CV risk. Suspected CV events were prospectively adjudicated. The empagliflozin 10 and...

  8. Atorvastatin reduces the risk of cardiovascular events in patients with carotid atherosclerosis: a secondary analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial

    DEFF Research Database (Denmark)

    Sillesen, H.; Amarenco, P.; Hennerici, M.G.

    2008-01-01

    BACKGROUND AND PURPOSE: The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial found that treatment with atorvastatin 80 mg per day reduced the risk of stroke and cardiovascular events in patients with a recent transient ischemic attack (TIA) or stroke. We hypothesized...... this benefit would be greatest in the subgroup of patients with carotid stenosis. METHODS: The SPARCL trial randomized patients with TIA or stroke within 1 to 6 months without known coronary heart disease (CHD) and low-density lipoprotein cholesterol 100 to 190 mg/dL to treatment with atorvastatin 80 mg per...

  9. Change in cardiovascular risk factors following early diagnosis of type 2 diabetes: a cohort analysis of a cluster-randomised trial

    OpenAIRE

    Black, James A; Sharp, Stephen J; Wareham, Nicholas J; Sandbæk, Annelli; Rutten, Guy EHM; Lauritzen, Torsten; Khunti, Kamlesh; Davies, Melanie J; Borch-Johnsen, Knut; Griffin, Simon J; Simmons, Rebecca K

    2014-01-01

    Background There is little evidence to inform the targeted treatment of individuals found early in the diabetes disease trajectory. Aim To describe cardiovascular disease (CVD) risk profiles and treatment of individual CVD risk factors by modelled CVD risk at diagnosis; changes in treatment, modelled CVD risk, and CVD risk factors in the 5 years following diagnosis; and how these are patterned by socioeconomic status. Design and setting Cohort analysis of a cluster-randomised trial (ADDITION-...

  10. Homocyst(e)ine and risk of cardiovascular disease in the multiple risk factor intervention trial.

    Science.gov (United States)

    Evans, R W; Shaten, B J; Hempel, J D; Cutler, J A; Kuller, L H

    2000-01-01

    A nested case-control study was undertaken involving men participating in the Multiple Risk Factor Intervention Trial (MRFIT). Serum samples from 712 men, stored for upto 20 years, were analysed for homocyst(e)ine. Cases involved non-fatal myocardial infractions, identified through the active phase of the study, which ended on February 28, 1982, and deaths due to coronary heart disease, monitored through 1990. The non-fatal myocardial infarction occurred within 7 years of sample collection, whereas the majority of coronary heart disease deaths occurred more than 11 years after sample collection. Mean homocyst(e)ine concentrations were in the expected range and did not differ significantly between case patients and control subjects: myocardial infarction cases, 12.6 micromol/L; myocardial infarction controls, 13.1 micromol/L; coronary heart disease death cases, 12.8 micromol/L; and coronary heart disease controls, 12.7 micromol/L. Odds ratios versus quartile 1 for coronary heart disease deaths and myocardial infarctions combined were as follows: quartile 2, 1.03; quartile 3, 0.84; and quartile 4, 0.92. Thus, in this prospective study, no association of homocyst(e)ine concentration with heart disease was detected. Homocyst(e)ine levels were weakly associated with the acute-phase (C-reactive) protein. These results are discussed with respect to the suggestion that homocyst(e)ine is an independent risk factor for heart disease.

  11. Routine evaluation of left ventricular diastolic function by cardiovascular magnetic resonance: A practical approach

    Directory of Open Access Journals (Sweden)

    Vido Diane

    2008-07-01

    Full Text Available Abstract Background Cardiovascular magnetic resonance (CMR has excellent capabilities to assess ventricular systolic function. Current clinical scenarios warrant routine evaluation of ventricular diastolic function for complete evaluation, especially in congestive heart failure patients. To our knowledge, no systematic assessment of diastolic function over a range of lusitropy has been performed using CMR. Methods and Results Left ventricular diastolic function was assessed in 31 subjects (10 controls who underwent CMR and compared with Transthoracic echocardiogram (TTE evaluation of mitral valve (MV and pulmonary vein (PV blood flow. Blood flow in the MV and PV were successfully imaged by CMR for all cases (31/31,100% while TTE evaluated flow in all MV (31/31,100% but only 21/31 PV (68% cases. Velocities of MV flow (E and A measured by CMR correlated well with TTE (r = 0.81, p Conclusion We have shown that there is homology between CMR and TTE for the assessment of diastolic inflow over a wide range of conditions, including normal, impaired relaxation and restrictive. There is excellent agreement of quantitative velocity measurements between CMR and TTE. Diastolic blood flow assessment by CMR can be performed in a single scan, with times ranging from 20 sec to 3 min, and we show that there is good indication for applying CMR to assess diastolic conditions, either as an adjunctive test when evaluating systolic function, or even as a primary test when TTE data cannot be obtained.

  12. Rationale, design, and baseline characteristics of a randomized, placebo-controlled cardiovascular outcome trial of empagliflozin (EMPA-REG OUTCOME™)

    Science.gov (United States)

    2014-01-01

    Background Evidence concerning the importance of glucose lowering in the prevention of cardiovascular (CV) outcomes remains controversial. Given the multi-faceted pathogenesis of atherosclerosis in diabetes, it is likely that any intervention to mitigate this risk must address CV risk factors beyond glycemia alone. The SGLT-2 inhibitor empagliflozin improves glucose control, body weight and blood pressure when used as monotherapy or add-on to other antihyperglycemic agents in patients with type 2 diabetes. The aim of the ongoing EMPA-REG OUTCOME™ trial is to determine the long-term CV safety of empagliflozin, as well as investigating potential benefits on macro-/microvascular outcomes. Methods Patients who were drug-naïve (HbA1c ≥7.0% and ≤9.0%), or on background glucose-lowering therapy (HbA1c ≥7.0% and ≤10.0%), and were at high risk of CV events, were randomized (1:1:1) and treated with empagliflozin 10 mg, empagliflozin 25 mg, or placebo (double blind, double dummy) superimposed upon the standard of care. The primary outcome is time to first occurrence of CV death, non-fatal myocardial infarction, or non-fatal stroke. CV events will be prospectively adjudicated by an independent Clinical Events Committee. The trial will continue until ≥691 confirmed primary outcome events have occurred, providing a power of 90% to yield an upper limit of the adjusted 95% CI for a hazard ratio of empagliflozin (both doses pooled). Hierarchical testing for superiority will follow for the primary outcome and key secondary outcomes (time to first occurrence of CV death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for unstable angina pectoris) where non-inferiority is achieved. Results Between Sept 2010 and April 2013, 592 clinical sites randomized and treated 7034 patients (41% from Europe, 20% from North America, and 19% from Asia). At baseline, the mean age was 63 ± 9 years, BMI 30.6 ± 5.3 kg/m2, HbA1c 8.1 ± 0.8%, and e

  13. Heart failure outcomes with empagliflozin in patients with type 2 diabetes at high cardiovascular risk: results of the EMPA-REG OUTCOME® trial

    Science.gov (United States)

    Fitchett, David; Zinman, Bernard; Wanner, Christoph; Lachin, John M.; Hantel, Stefan; Salsali, Afshin; Johansen, Odd Erik; Woerle, Hans J.; Broedl, Uli C.; Inzucchi, Silvio E.

    2016-01-01

    Abstract Aims We previously reported that in the EMPA-REG OUTCOME® trial, empagliflozin added to standard of care reduced the risk of 3-point major adverse cardiovascular events, cardiovascular and all-cause death, and hospitalization for heart failure in patients with type 2 diabetes and high cardiovascular risk. We have now further investigated heart failure outcomes in all patients and in subgroups, including patients with or without baseline heart failure. Methods and results Patients were randomized to receive empagliflozin 10 mg, empagliflozin 25 mg, or placebo. Seven thousand and twenty patients were treated; 706 (10.1%) had heart failure at baseline. Heart failure hospitalization or cardiovascular death occurred in a significantly lower percentage of patients treated with empagliflozin [265/4687 patients (5.7%)] than with placebo [198/2333 patients (8.5%)] [hazard ratio, HR: 0.66 (95% confidence interval: 0.55–0.79); P heart failure hospitalization or cardiovascular death of 35 over 3 years. Consistent effects of empagliflozin were observed across subgroups defined by baseline characteristics, including patients with vs. without heart failure, and across categories of medications to treat diabetes and/or heart failure. Empagliflozin improved other heart failure outcomes, including hospitalization for or death from heart failure [2.8 vs. 4.5%; HR: 0.61 (0.47–0.79); P heart failure at baseline in both treatment groups, but were no more common with empagliflozin than with placebo. Conclusion In patients with type 2 diabetes and high cardiovascular risk, empagliflozin reduced heart failure hospitalization and cardiovascular death, with a consistent benefit in patients with and without baseline heart failure. PMID:26819227

  14. Ebola Virus Disease Candidate Vaccines Under Evaluation in Clinical Trials

    Science.gov (United States)

    Martins, Karen A.; Jahrling, Peter B.; Bavari, Sina; Kuhn, Jens H.

    2016-01-01

    Summary Filoviruses are the etiological agents of two human illnesses: Ebola virus disease and Marburg virus disease. Until 2013, medical countermeasure development against these afflictions was limited to only a few research institutes worldwide as both infections were considered exotic due to very low case numbers. Together with the high case-fatality rate of both diseases, evaluation of any candidate countermeasure in properly controlled clinical trials seemed impossible. However, in 2013, Ebola virus was identified as the etiological agent of a large disease outbreak in Western Africa including almost 30,000 infections and more than 11,000 deaths, including case exportations to Europe and North America. These large case numbers resulted in medical countermeasure development against Ebola virus disease becoming a global public-health priority. This review summarizes the status quo of candidate vaccines against Ebola virus disease, with a focus on those that are currently under evaluation in clinical trials. PMID:27160784

  15. Clinical uses of melatonin: evaluation of human trials.

    Science.gov (United States)

    Sánchez-Barceló, E J; Mediavilla, M D; Tan, D X; Reiter, R J

    2010-01-01

    During the last 20 years, numerous clinical trials have examined the therapeutic usefulness of melatonin in different fields of medicine. The objective of this article is to review, in depth, the science regarding clinical trials performed to date. The efficacy of melatonin has been assessed as a treatment of ocular diseases, blood diseases, gastrointestinal tract diseases, cardiovascular diseases, diabetes, rheumatoid arthritis, fibromyalgia, chronic fatigue syndrome, infectious diseases, neurological diseases, sleep disturbances, aging and depression. Melatonin has been also used as a complementary treatment in anaesthesia, hemodialysis, in vitro fertilization and neonatal care. The conclusion of the current review is that the use of melatonin as an adjuvant therapy seems to be well funded for macular degeneration, glaucoma, protection of the gastric mucosa, irritable bowel syndrome, arterial hypertension, diabetes, side effects of chemotherapy and radiation in cancer patients or hemodialysis in patients with renal insufficiency and, especially, for sleep disorders of circadian etiology (jet lag, delayed sleep phase syndrome, sleep deterioration associated with aging, etc.) as well as in those related with neurological degenerative diseases (Alzheimer, etc.,) or Smith-Magenis syndrome. The utility of melatonin in anesthetic procedures has been also confirmed. More clinical studies are required to clarify whether, as the preliminary data suggest, melatonin is useful for treatment of fibromyalgia, chronic fatigue syndrome, infectious diseases, neoplasias or neonatal care. Preliminary data regarding the utility of melatonin in the treatment of ulcerative colitis, Crohn's disease, rheumatoid arthritis are either ambiguous or negative. Although in a few cases melatonin seems to aggravate some conditions, the vast majority of studies document the very low toxicity of melatonin over a wide range of doses.

  16. Report of a European Society of Cardiology-European Association of Percutaneous Cardiovascular Interventions task force on the evaluation of coronary stents in Europe: executive summary.

    Science.gov (United States)

    Byrne, Robert A; Serruys, Patrick W; Baumbach, Andreas; Escaned, Javier; Fajadet, Jean; James, Stefan; Joner, Michael; Oktay, Semih; Jüni, Peter; Kastrati, Adnan; Sianos, George; Stefanini, Giulio G; Wijns, William; Windecker, Stephan

    2015-10-07

    The evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the evaluation of coronary stents (Appendix 1 of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical evaluation pathway for market approval. The two-stage clinical evaluation plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force's report. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

  17. The effect of different cardiovascular risk presentation formats on intentions, understanding and emotional affect: a randomised controlled trial using a web-based risk formatter (protocol

    Directory of Open Access Journals (Sweden)

    Newcombe Robert

    2010-07-01

    Full Text Available Abstract Background The future risk of heart disease can be predicted with increasing precision. However, more research is needed into how this risk is conveyed and presented. The aim of this study is to compare the effects of presenting cardiovascular risk in different formats on individuals' intention to change behaviour to reduce risk, understanding of risk information and emotional affect. Methods/design A randomised controlled trial comprising four arms, with a between subjects design will be performed. There will be two intervention groups and two control groups. The first control comprises a pre-intervention questionnaire and presents risk in a bar graph format. The second control presents risk in a bar graph format without pre-intervention questionnaire. These two control groups are to account for the potential Hawthorne effect of thinking about cardiovascular risk before viewing actual risk. The two intervention groups comprise presenting risk in either a pictogram or metonym format (image depicting seriousness of having a myocardial infarction. 800 individuals' aged between 45 and 64 years, who have not been previously diagnosed with heart disease and have access to a computer with internet, will be given a link to a website comprising a risk calculator and electronic questionnaires. 10-year risk of having a coronary heart disease event will be assessed and presented in one of the three formats. A post-intervention questionnaire will be completed after viewing the risk format. Main outcome measures are (i intention to change behaviour, (ii understanding of risk information, (iii emotional affect and (iv worry about future heart disease. Secondary outcomes are the sub-components of the theory of planned behaviour: attitudes, perceived behavioural control and subjective norms. Discussion Having reviewed the literature, we are not aware of any other studies which have used the assessment of actual risk, in a trial to compare different

  18. Rationale and design of the Statins Evaluation in Coronary procedUres and REvascularization: The SECURE-PCI Trial.

    Science.gov (United States)

    Berwanger, Otavio; de Barros E Silva, Pedro G M; Dall Orto, Frederico Toledo Campo; de Andrade, Pedro Beraldo; de Castro Bienert, Igor Ribeiro; Bosso, Carlos Eduardo; Mangione, José; Polanczyk, Carisi Anne; Sousa, Amanda; Kalil, Renato; de Moura Santos, Luciano; Sposito, Andrei C; Rech, Rafael L; Sousa, Antonio Carlos Sobral; Baldissera, Felipe; Nascimento, Bruno Ramos; de Andrade Jesuíno, Isabella; Santucci, Eliana Vieira; Damiani, Lucas Petri; Laranjeira, Ligia N; Borges de Oliveira, Juliana A; Giraldez, Roberto R; Cavalcanti, Alexandre Biasi; Pereira, Sabrina Bernardez; Mattos, Luiz Alberto; Armaganijan, Luciana Vidal; Guimarães, Hélio Penna; Sousa, José Eduardo; Alexander, John H; Granger, Christopher B; Lopes, Renato D

    2018-04-01

    Previous evidence suggests that acute treatment with statins reduce atherosclerotic complications, including periprocedural myocardial infarction, but currently, there are no large, adequately powered studies to define the effects of early, high-dose statins in patients with acute coronary syndrome (ACS) and planned invasive management. The main goal of Statins Evaluation in Coronary procedUres and REvascularization (SECURE-PCI) Trial is to determine whether the early use of a loading dose of 80 mg of atorvastatin before an intended percutaneous coronary intervention followed by an additional dose of 80 mg 24 hours after the procedure will be able to reduce the rates of major cardiovascular events at 30 days in patients with an ACS. The SECURE-PCI study is a pragmatic, multicenter, double-blind, placebo-controlled randomized trial planned to enroll around 4,200 patients in 58 different sites in Brazil. The primary outcome is the rate of major cardiovascular events at 30 days defined as a composite of all-cause mortality, nonfatal acute myocardial infarction, nonfatal stroke, and coronary revascularization. The SECURE PCI is a large randomized trial testing a strategy of early, high-dose statin in patients with ACS and will provide important information about the acute treatment of this patient population. Copyright © 2018 Elsevier Inc. All rights reserved.

  19. Rationale, design and baseline characteristics of the CANagliflozin cardioVascular Assessment Study-Renal (CANVAS-R): A randomized, placebo-controlled trial.

    Science.gov (United States)

    Neal, Bruce; Perkovic, Vlado; Matthews, David R; Mahaffey, Kenneth W; Fulcher, Greg; Meininger, Gary; Erondu, Ngozi; Desai, Mehul; Shaw, Wayne; Vercruysse, Frank; Yee, Jacqueline; Deng, Hsiaowei; de Zeeuw, Dick

    2017-03-01

    The primary aim of the CANagliflozin cardioVascular Assessment Study-Renal (CANVAS-R) is to determine whether the favourable effects of inhibition of the sodium glucose co-transporter 2 (SGLT2) on blood glucose, blood pressure and body weight are accompanied by protection against adverse renal outcomes. CANVAS-R is a prospective, randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes with a history or high risk of cardiovascular events. Patients were randomly assigned to once-daily placebo or canagliflozin 100 mg (with optional uptitration to 300 mg) for a planned average of 2.5 years of follow-up. The primary outcome is kidney disease progression, defined by class change in albuminuria. The two secondary outcomes are the composite of hospitalized heart failure or cardiovascular death, and cardiovascular death alone. Effects on end-stage renal disease and a range of other outcomes will also be explored. A total of 5812 participants were recruited at 422 sites in 24 countries between January 2014 and May 2015. The mean baseline age was 64 years, mean duration of diabetes was 14 years, mean glycated haemoglobin level was 8.3% and mean body mass index was 32 kg/m 2 . Of these participants, 37% were women, 71% had a history of cardiovascular disease, 22.3% had microalbuminuria and 8.7% had macroalbuminuria. The mean baseline estimated glomerular filtration rate was 76 mL/min/1.73 m 2 . The study will have at least 90% power ( P = .05) to detect a 22% or greater reduction in the risk of progression of albuminuria. The trial should define the potential renoprotective effect of canagliflozin and will provide additional important new data about its effects on vascular outcomes, death and kidney failure. © 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

  20. Review of existing experimental approaches for the clinical evaluation of the benefits of plant food supplements on cardiovascular function.

    Science.gov (United States)

    Meoni, Paolo; Restani, Patrizia; Mancama, Dalu T

    2013-06-01

    We conducted a survey of the National Centre for Biotechnology Information (NCBI) PubMed database to identify methods most commonly used for the evaluation of the effect of plant food supplements on the cardiovascular system and their relevance to the regulatory status of these products. Particularly, our search strategy was aimed at the selection of studies concerning the clinical evaluation of the beneficial effects of the most commonly studied plant food supplements acting on the cardiovascular system. Following the screening of 3839 papers for inclusion criteria, 48 published reports were retained for this review. Most studies included in this review used a double blind controlled design, and evaluated the effect of plant food supplements on individuals affected by a disease of the cardiovascular system. The majority of the studies were found to be of low methodological quality on the Jadad scale, mainly because of inadequate reporting of adverse events and of patient withdrawals. In comparison, measures used for the evaluation of benefits included mostly cardiovascular risk factors as recommended in international guidelines and in accordance with principles laid down for the evaluation of health claims in food. The risk factors most frequently evaluated belonged to the category of "lipid function and levels", "heart function" and "blood pressure". For the absolute majority of the studies, the study period did not exceed one month. This review highlights critical factors to be considered in the design of studies evaluating the health effects of plant food supplements on the cardiovascular system. Between others, the inclusion of healthy individuals, better reporting and description of the characteristics of the product used could improve the quality and relevance of these studies.

  1. An international randomised placebo-controlled trial of a four-component combination pill ("polypill" in people with raised cardiovascular risk.

    Directory of Open Access Journals (Sweden)

    Anthony Rodgers

    Full Text Available There has been widespread interest in the potential of combination cardiovascular medications containing aspirin and agents to lower blood pressure and cholesterol ('polypills' to reduce cardiovascular disease. However, no reliable placebo-controlled data are available on both efficacy and tolerability.We conducted a randomised, double-blind placebo-controlled trial of a polypill (containing aspirin 75 mg, lisinopril 10 mg, hydrochlorothiazide 12.5 mg and simvastatin 20 mg in 378 individuals without an indication for any component of the polypill, but who had an estimated 5-year cardiovascular disease risk over 7.5%. The primary outcomes were systolic blood pressure (SBP, LDL-cholesterol and tolerability (proportion discontinued randomised therapy at 12 weeks follow-up.At baseline, mean BP was 134/81 mmHg and mean LDL-cholesterol was 3.7 mmol/L. Over 12 weeks, polypill treatment reduced SBP by 9.9 (95% CI: 7.7 to 12.1 mmHg and LDL-cholesterol by 0.8 (95% CI 0.6 to 0.9 mmol/L. The discontinuation rates in the polypill group compared to placebo were 23% vs 18% (RR 1.33, 95% CI 0.89 to 2.00, p = 0.2. There was an excess of side effects known to the component medicines (58% vs 42%, p = 0.001, which was mostly apparent within a few weeks, and usually did not warrant cessation of trial treatment.This polypill achieved sizeable reductions in SBP and LDL-cholesterol but caused side effects in about 1 in 6 people. The halving in predicted cardiovascular risk is moderately lower than previous estimates and the side effect rate is moderately higher. Nonetheless, substantial net benefits would be expected among patients at high risk.Australian New Zealand Clinical Trials Registry ACTRN12607000099426.

  2. Dyslipidemia and Risk of Cardiovascular Events in Patients With Atrial Fibrillation Treated With Oral Anticoagulation Therapy: Insights From the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) Trial.

    Science.gov (United States)

    Pol, Tymon; Held, Claes; Westerbergh, Johan; Lindbäck, Johan; Alexander, John H; Alings, Marco; Erol, Cetin; Goto, Shinya; Halvorsen, Sigrun; Huber, Kurt; Hanna, Michael; Lopes, Renato D; Ruzyllo, Witold; Granger, Christopher B; Hijazi, Ziad

    2018-02-01

    Dyslipidemia is a major risk factor for cardiovascular events. The prognostic importance of lipoproteins in patients with atrial fibrillation is not well understood. We aimed to explore the association between apolipoprotein A1 (ApoA1) and B (ApoB) and cardiovascular events in patients with atrial fibrillation receiving oral anticoagulation. Using data from the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial, ApoA1 and ApoB plasma levels were measured at baseline in 14 884 atrial fibrillation patients. Median length of follow-up was 1.9 years. Relationships between continuous levels of ApoA1 and ApoB and clinical outcomes were evaluated using Cox models adjusted for cardiovascular risk factors, medication including statins, and cardiovascular biomarkers. A composite ischemic outcome (ischemic stroke, systemic embolism, myocardial infarction, and cardiovascular death) was used as the primary end point. Median (25th, 75th) ApoA1 and ApoB levels were 1.10 (0.93, 1.30) and 0.70 g/L (0.55, 0.85), respectively. In adjusted analyses, higher levels of ApoA1 were independently associated with a lower risk of the composite ischemic outcome (hazard ratio, 0.81; P <0.0001). Similar results were observed for the individual components of the composite outcome. ApoB was not significantly associated with the composite ischemic outcome ( P =0.8240). Neither apolipoprotein was significantly associated with major bleeding. There was no interaction between lipoproteins and randomized treatment for the primary outcome (both P values ≥0.2448). In patients with atrial fibrillation on oral anticoagulation, higher levels of ApoA1 were independently associated with lower risk of ischemic cardiovascular outcomes. Investigating therapies targeting dyslipidemia may thus be useful to improve cardiovascular outcomes in patients with atrial fibrillation. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00412984. © 2018 The

  3. Rationale and design of a multicenter placebo-controlled double-blind randomized trial to evaluate the effect of empagliflozin on endothelial function: the EMBLEM trial.

    Science.gov (United States)

    Tanaka, Atsushi; Shimabukuro, Michio; Okada, Yosuke; Taguchi, Isao; Yamaoka-Tojo, Minako; Tomiyama, Hirofumi; Teragawa, Hiroki; Sugiyama, Seigo; Yoshida, Hisako; Sato, Yasunori; Kawaguchi, Atsushi; Ikehara, Yumi; Machii, Noritaka; Maruhashi, Tatsuya; Shima, Kosuke R; Takamura, Toshinari; Matsuzawa, Yasushi; Kimura, Kazuo; Sakuma, Masashi; Oyama, Jun-Ichi; Inoue, Teruo; Higashi, Yukihito; Ueda, Shinichiro; Node, Koichi

    2017-04-12

    Type 2 diabetes mellitus (T2DM) is characterized by systemic metabolic abnormalities and the development of micro- and macrovascular complications, resulting in a shortened life expectancy. A recent cardiovascular (CV) safety trial, the EMPA-REG OUTCOME trial, showed that empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, markedly reduced CV death and all-cause mortality and hospitalization for heart failure in patients with T2DM and established CV disease (CVD). SGLT2 inhibitors are known to not only decrease plasma glucose levels, but also favorably modulate a wide range of metabolic and hemodynamic disorders related to CV pathways. Although some experimental studies revealed a beneficial effect of SGLT2 inhibitors on atherosclerosis, there is a paucity of clinical data showing that they can slow the progression of atherosclerosis in patients with T2DM. Therefore, the EMBLEM trial was designed to investigate whether empagliflozin treatment can improve endothelial function, which plays a pivotal role in the pathogenesis of atherosclerosis, in patients with T2DM and established CVD. The EMBLEM trial is an ongoing, prospective, multicenter, placebo-controlled double-blind randomized, investigator-initiated clinical trial in Japan. A total of 110 participants with T2DM (HbA1c range 6.0-10.0%) and with established CVD will be randomized (1:1) to receive either empagliflozin 10 mg once daily or a placebo. The primary endpoint of the trial is change in the reactive hyperemia (RH)-peripheral arterial tonometry-derived RH index at 24 weeks from baseline. For comparison of treatment effects between the treatment groups, the baseline-adjusted means and their 95% confidence intervals will be estimated by analysis of covariance adjusted for the following allocation factors: HbA1c (EMBLEM is the first trial to assess the effect of empagliflozin on endothelial function in patients with T2DM and established CVD. Additionally, mechanisms associating

  4. Cardiovascular disease medication health literacy among Indigenous peoples: design and protocol of an intervention trial in Indigenous primary care services.

    Science.gov (United States)

    Crengle, Sue; Smylie, Janet; Kelaher, Margaret; Lambert, Michelle; Reid, Susan; Luke, Joanne; Anderson, Ian; Harré Hindmarsh, Jennie; Harwood, Matire

    2014-07-12

    Cardiovascular diseases (CVD) are leading causes of mortality and morbidity among Indigenous people in New Zealand, Australia and Canada and are a major driver of the inequities in life expectancy between Indigenous and non-Indigenous people in these countries. Evidence-based pharmaceutical management of CVD can significantly reduce mortality and morbidity for persons diagnosed with CVD or for those at intermediate or high risk of CVD. Health literacy has been identified as a major barrier in the communication and implementation of appropriate pharmaceutical management plans for CVD. Addressing health literacy is particularly relevant in Indigenous populations where there are unique health and adult literacy challenges. This study will examine the effect of a customized, structured CVD medication programme, delivered by health professionals, on the health literacy of Indigenous people with, or at risk, of CVD. Primary outcomes are patient's knowledge about CVD medications; secondary outcomes examine changes in health literacy skills and practices. The study will employ a multi-site pre-post design with multiple measurement points to assess intervention efficacy. Participants will be recruited from four Indigenous primary care services in Australia, Canada and New Zealand. Three educational sessions will be delivered over four weeks. A tablet application will support the education sessions and produce a customized pill card for each participant. Participants will be provided with written information about CVD medications. Medication knowledge scores, and specific health literacy skills and practices will be assessed before and after the three sessions. Statistical analyses will identify significant changes in outcomes over each session, and from the pre-session one to post-session three time points. This study will make an important contribution to understanding the effect of a structured primary care-based intervention on CVD health literacy in Indigenous

  5. Electronic health record-based patient identification and individualized mailed outreach for primary cardiovascular disease prevention: a cluster randomized trial.

    Science.gov (United States)

    Persell, Stephen D; Lloyd-Jones, Donald M; Friesema, Elisha M; Cooper, Andrew J; Baker, David W

    2013-04-01

    Many individuals at higher risk for cardiovascular disease (CVD) do not receive recommended treatments. Prior interventions using personalized risk information to promote prevention did not test clinic-wide effectiveness. To perform a 9-month cluster-randomized trial, comparing a strategy of electronic health record-based identification of patients with increased CVD risk and individualized mailed outreach to usual care. Patients of participating physicians with a Framingham Risk Score of at least 5 %, low-density lipoprotein (LDL)-cholesterol level above guideline threshold for drug treatment, and not prescribed a lipid-lowering medication were included in the intention-to-treat analysis. Patients of physicians randomized to the intervention group were mailed individualized CVD risk messages that described benefits of using a statin (and controlling hypertension or quitting smoking when relevant). The primary outcome was occurrence of a LDL-cholesterol level, repeated in routine practice, that was at least 30 mg/dl lower than prior. A secondary outcome was lipid-lowering drug prescribing. Clinicaltrials.gov identifier: NCT01286311. Fourteen physicians with 218 patients were randomized to intervention, and 15 physicians with 217 patients to control. The mean patient age was 60.7 years and 77% were male. There was no difference in the primary outcome (11.0 % vs. 11.1 %, OR 0.99, 95 % CI 0.56-1.74, P = 0.96), but intervention group patients were twice as likely to receive a prescription for lipid-lowering medication (11.9 %, vs. 6.0 %, OR 2.13, 95 % CI 1.05-4.32, p = 0.038). In post hoc analysis with extended follow-up to 18 months, the primary outcome occurred more often in the intervention group (22.5 % vs. 16.1 %, OR 1.59, 95 % CI 1.05-2.41, P = 0.029). In this effectiveness trial, individualized mailed CVD risk messages increased the frequency of new lipid-lowering drug prescriptions, but we observed no difference in proportions lowering LDL

  6. Evaluation of the Usability of Selected Questionnaires Assessing Physical Activity in the Prophylaxis of Cardiovascular Diseases.

    Science.gov (United States)

    Czeczelewska, Ewa; Czeczelewski, Jan; Wasiluk, Agnieszka; Saczuk, Jerzy

    2016-01-01

    The main health problem of the Polish population is posed by cardiovascular diseases (CDVD), coronary artery disease (CAD) in particular. Respectively higher physical activity linked with energy expenditure of at least 1000 kcal/week may significantly reduce the risk of CAD development. The protective effect of exercise applies not only to persons from high-risk groups and with diagnosed chronic diseases that increase the risk of the incidence of atherosclerosis and its complications, but also to healthy individuals. The aim of this study was to evaluate the usability of the Seven-Day Physical Activity Recall (SDPAR) and International Physical Activity Questionnaire (IPAQ) in research on the correlation between physical activity and risk factors of cardiovascular diseases. A screening survey, conducted in 2012, included students (n = 340) of the Division of the Academy of Physical Education in Biała Podlaska, aged 18-29 years. Total cholesterol, triglycerides and glucose levels were analyzed, and arterial blood pressure and heart rate were measured. The physical activity of the students was estimated using IPAQ and SDPAR questionnaires. The effect of physical activity on the biochemical blood markers, arterial blood pressure and heart rate was analyzed in groups differing in weekly energy expenditure (WEE). Along with increasing WEE values, calculated with IPAQ and SDPAR questionnaires, tangible descending tendencies were observed in cholesterol concentration in both genders. Significant differences were demonstrated in mean values of the resting heart rate between terciles of women ranked according to the increasing WEE values calculated using IPAQ (p blood lipid profile and in mean resting heart rate values as affected by the higher energy expenditure. The IPAQ and SDPAR may be applied to assess the level of physical activity; however the SDPAR seems to be a more useful tool in CDVD prevention screening.

  7. Efficacy of Feedback-Controlled Robotics-Assisted Treadmill Exercise to Improve Cardiovascular Fitness Early After Stroke: A Randomized Controlled Pilot Trial.

    Science.gov (United States)

    Stoller, Oliver; de Bruin, Eling D; Schindelholz, Matthias; Schuster-Amft, Corina; de Bie, Rob A; Hunt, Kenneth J

    2015-07-01

    Cardiovascular fitness is greatly reduced after stroke. Although individuals with mild to moderate impairments benefit from conventional cardiovascular exercise interventions, there is a lack of effective approaches for persons with severely impaired physical function. This randomized controlled pilot trial investigated efficacy and feasibility of feedback-controlled robotics-assisted treadmill exercise (FC-RATE) for cardiovascular rehabilitation in persons with severe impairments early after stroke. Twenty individuals (age 61 ± 11 years; 52 ± 31 days poststroke) with severe motor limitations (Functional Ambulation Classification 0-2) were recruited for FC-RATE or conventional robotics-assisted treadmill exercise (RATE) (4 weeks, 3 × 30-minute sessions/wk). Outcome measures focused on peak cardiopulmonary performance parameters, training intensity, and feasibility, with examiners blinded to allocation. All 14 allocated participants (70% of recruited) completed the intervention (7/group, withdrawals unrelated to intervention), without serious adverse events occurring. Cardiovascular fitness increased significantly in both groups, with peak oxygen uptake increasing from 14.6 to 17.7 mL · kg · min (+17.8%) after 4 weeks (45.8%-55.7% of predicted maximal aerobic capacity; time effect P = 0.01; no group-time interaction). Training intensity (% heart rate reserve) was significantly higher for FC-RATE (40% ± 3%) than for conventional RATE (14% ± 2%) (P = 0.001). Substantive overall increases in the main cardiopulmonary performance parameters were observed, but there were no significant between-group differences when comparing FC-RATE and conventional RATE. Feedback-controlled robotics-assisted treadmill exercise significantly increased exercise intensity, but recommended intensity levels for cardiovascular training were not consistently achieved. Future research should focus on appropriate algorithms within advanced robotic systems to promote optimal cardiovascular

  8. Effects of glucagon-like peptide-1 receptor agonists on mortality and cardiovascular events: A comprehensive meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Monami, Matteo; Zannoni, Stefania; Pala, Laura; Silverii, Antonio; Andreozzi, Francesco; Sesti, Giorgio; Mannucci, Edoardo

    2017-08-01

    The publication of the results of LEADER and SUSTAIN-6 trials suggested a possible beneficial effect of the class of GLP-1 receptor agonists on cardiovascular morbidity and mortality. The aim of the present meta-analysis is to collect and synthetize all available evidence on the effect of GLP-1 receptor agonists on cardiovascular events and mortality. A Medline search for GLP-1 receptor agonists (exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, or semaglutide) was performed, collecting all randomized clinical trials with a duration >11weeks, enrolling patients with type 2 diabetes, and comparing a GLP-1 receptor agonist with placebo or any other non-GLP-1 receptor agonist drug. The principal outcome of this analysis was the effect of GLP-1 receptor agonists on all-cause and cardiovascular mortality, overall (fatal plus nonfatal) myocardial infarction, stroke, and heart failure. Out of 113 trials fulfilling inclusion criteria (mean duration 41.7±38.2weeks), 32, 25, 48, 43 and 32 reported at least one event for all-cause and cardiovascular mortality, overall (fatal plus nonfatal) myocardial infarction, stroke, and heart failure, respectively. In GLP-1 receptor agonist-treated patients, all-cause mortality, cardiovascular mortality, and myocardial infarction were significantly lower than in comparators (MH-OR [95% CI] 0.88 [0.79-0.97], p=0.015, 0.84 [0.74-0.96], p=0.009, and 0.90 [0.80-1.00], p=0.050, respectively), whereas no beneficial effect was observed for stroke and heart failure (MH-OR [95% CI] 0.90 [0.81-1.00]. p=0.059. 0.89 [0.76-1.04]. p=0.15. and 0.92 [0.81-1.06]. p=0.25. respectively). Overall, the agents of this class appear to reduce all-cause mortality, cardiovascular mortality, and the incidence of myocardial infarction at mid-term follow up. Copyright © 2017 Elsevier B.V. All rights reserved.

  9. Comparative effectiveness of lifestyle interventions on cardiovascular risk factors among a Dutch overweight working population: A randomized controlled trial

    NARCIS (Netherlands)

    Dekkers, J.C.; Wier, M.F. van; Arins, G.A.M.; Hendriksen, I.J.M.; Pronk, N.P.; Smid, T.; Mechelen, W. van

    2011-01-01

    Background: Overweight (Body Mass Index [BMI] ≥ 25 kg/m2) and obesity (BMI ≥ 30 kg/m2) are associated with increased cardiovascular risk, posing a considerable burden to public health. The main aim of this study was to investigate lifestyle intervention effects on cardiovascular risk factors in

  10. Defendant's or convict's competency to stand trial - forensic psychiatric evaluation.

    Science.gov (United States)

    Cynkier, Przemysław N

    2017-01-01

    The purpose of this paper was to draw attention to particularly important aspects of pronouncing forensic psychiatric judgment regarding the accused or convicted individuals' competency to stand trial. The level of a person's mental capacity should be established using a structured psychiatric interview concerning a variety of aspects of a trial. Emphasis should be placed on evaluating the defendant's consciousness of the charges, knowledge of the potential punishment, ability to make significant decisions and be engaged in defense, knowledge about the role that particular people present in the courtroom play, understanding of the meaning of the evidence gathered in the case, the risk of aggression. The analysis should take into account the specificity of the mental disorder, the influence of proceedings on the course of disorder, as well as the presence of reactive disorders. Using testing tools by the expert can facilitate the process of evaluation to a certain degree. Forensic psychiatric evaluations can give rise to difficulties for the experts, what with the changing legal regulations and their interpretations. It would be justified to develop the standards of evaluation in this kind of cases, which would on the one hand apply to experts but which would also be respected by the judicial organ.

  11. Implementation of case management to reduce cardiovascular disease risk in the Stanford and San Mateo Heart to Heart randomized controlled trial: study protocol and baseline characteristics

    Directory of Open Access Journals (Sweden)

    Stafford Randall S

    2006-09-01

    Full Text Available Abstract Background Case management has emerged as a promising alternative approach to supplement traditional one-on-one sessions between patients and doctors for improving the quality of care in chronic diseases such as coronary heart disease (CHD. However, data are lacking in terms of its efficacy and cost-effectiveness when implemented in ethnic and low-income populations. Methods The Stanford and San Mateo Heart to Heart (HTH project is a randomized controlled clinical trial designed to rigorously evaluate the efficacy and cost-effectiveness of a multi-risk cardiovascular case management program in low-income, primarily ethnic minority patients served by a local county health care system in California. Randomization occurred at the patient level. The primary outcome measure is the absolute CHD risk over 10 years. Secondary outcome measures include adherence to guidelines on CHD prevention practice. We documented the study design, methodology, and baseline sociodemographic, clinical and lifestyle characteristics of 419 participants. Results We achieved equal distributions of the sociodemographic, biophysical and lifestyle characteristics between the two randomization groups. HTH participants had a mean age of 56 years, 63% were Latinos/Hispanics, 65% female, 61% less educated, and 62% were not employed. Twenty percent of participants reported having a prior cardiovascular event. 10-year CHD risk averaged 18% in men and 13% in women despite a modest low-density lipoprotein cholesterol level and a high on-treatment percentage at baseline. Sixty-three percent of participants were diagnosed with diabetes and an additional 22% had metabolic syndrome. In addition, many participants had depressed high-density lipoprotein (HDL cholesterol levels and elevated values of total cholesterol-to-HDL ratio, triglycerides, triglyceride-to-HDL ratio, and blood pressure. Furthermore, nearly 70% of participants were obese, 45% had a family history of CHD or

  12. HDL cholesterol and residual risk of first cardiovascular events after treatment with potent statin therapy: an analysis from the JUPITER trial.

    Science.gov (United States)

    Ridker, Paul M; Genest, Jacques; Boekholdt, S Matthijs; Libby, Peter; Gotto, Antonio M; Nordestgaard, Børge G; Mora, Samia; MacFadyen, Jean G; Glynn, Robert J; Kastelein, John J P

    2010-07-31

    HDL-cholesterol concentrations are inversely associated with occurrence of cardiovascular events. We addressed, using the JUPITER trial cohort, whether this association remains when LDL-cholesterol concentrations are reduced to the very low ranges with high-dose statin treatment. Participants in the randomised placebo-controlled JUPITER trial were adults without diabetes or previous cardiovascular disease, and had baseline concentrations of LDL cholesterol of less than 3.37 mmol/L and high-sensitivity C-reactive protein of 2 mg/L or more. Participants were randomly allocated by a computer-generated sequence to receive rosuvastatin 20 mg per day or placebo, with participants and adjudicators masked to treatment assignment. In the present analysis, we divided the participants into quartiles of HDL-cholesterol or apolipoprotein A1 and sought evidence of association between these quartiles and the JUPITER primary endpoint of first non-fatal myocardial infarction or stroke, hospitalisation for unstable angina, arterial revascularisation, or cardiovascular death. This trial is registered with ClinicalTrials.gov, number NCT00239681. For 17,802 patients in the JUPITER trial, rosuvastatin 20 mg per day reduced the incidence of the primary endpoint by 44% (p<0.0001). In 8901 (50%) patients given placebo (who had a median on-treatment LDL-cholesterol concentration of 2.80 mmol/L [IQR 2.43-3.24]), HDL-cholesterol concentrations were inversely related to vascular risk both at baseline (top quartile vs bottom quartile hazard ratio [HR] 0.54, 95% CI 0.35-0.83, p=0.0039) and on-treatment (0.55, 0.35-0.87, p=0.0047). By contrast, among the 8900 (50%) patients given rosuvastatin 20 mg (who had a median on-treatment LDL-cholesterol concentration of 1.42 mmol/L [IQR 1.14-1.86]), no significant relationships were noted between quartiles of HDL-cholesterol concentration and vascular risk either at baseline (1.12, 0.62-2.03, p=0.82) or on-treatment (1.03, 0.57-1.87, p=0.97). Our analyses

  13. Cardiovascular adverse effects of phenytoin.

    Science.gov (United States)

    Guldiken, B; Rémi, J; Noachtar, Soheyl

    2016-05-01

    Phenytoin is an established drug in the treatment of acute repetitive seizures and status epilepticus. One of its main advantages over benzodiazepines is the less sedative effect. However, the possibility of cardiovascular adverse effects with the intravenous use of phenytoin cause a reluctance to its usage, and this has lead to a search for safer anticonvulsant drugs. In this study, we aimed to review the studies which evaluated the safety of phenytoin with respect to cardiovascular adverse effects. The original clinical trials and case reports listed in PUBMED in English language between the years of 1946-2014 were evaluated. As the key words, "phenytoin, diphenylhydantoin, epilepsy, seizure, cardiac toxicity, asystole, arrhythmia, respiratory arrest, hypotension, death" were used. Thirty-two clinical trials and ten case reports were identified. In the case reports, a rapid infusion rate (>50 mg/min) of phenytoin appeared as the major cause of increased mortality. In contrast, no serious cardiovascular adverse effects leading to death were met in the clinical trials which applied the recommended infusion rate and dosages. An infusion rate of 50 mg/min was reported to be safe for young patients. For old patients and patients with a cardiovascular co-morbidity, a slower infusion rate was recommended with a careful follow-up of heart rhythm and blood pressure. No cardiovascular adverse effect was reported in oral phenytoin overdoses except one case with a very high serum phenytoin level and hypoalbuminemia. Phenytoin is an effective and well tolerated drug in the treatment of epilepsy. Intravenous phenytoin is safe when given at recommended infusion rates and doses.

  14. Design of a Randomized Controlled Trial of a Web-Based Intervention to Reduce Cardiovascular Disease Risk Factors among Remote Reservation-Dwelling American Indian Adults with Type 2 Diabetes

    Science.gov (United States)

    Henderson, Jeffrey A.; Chubak, Jessica; O'Connell, Joan; Ramos, Maria C.; Jensen, Julie; Jobe, Jared B.

    2012-01-01

    We describe a randomized controlled trial, the Lakota Oyate Wicozani Pi Kte (LOWPK) trial, which was designed to determine whether a Web-based diabetes and nutritional intervention can improve risk factors related to cardiovascular disease (CVD) among a group of remote reservation-dwelling adult American Indian men and women with type 2 diabetes…

  15. A pragmatic cluster randomised trial evaluating three implementation interventions

    Directory of Open Access Journals (Sweden)

    Rycroft-Malone Jo

    2012-08-01

    Full Text Available Abstract Background Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting. Methods A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA. The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients’ experiences, and stakeholders’ experiences of implementation, including influences. ANOVA was used to test differences over time and interventions. Results Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility. Conclusions This was a large, complex study and one of the first

  16. A pragmatic cluster randomised trial evaluating three implementation interventions

    Science.gov (United States)

    2012-01-01

    Background Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting. Methods A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD) of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA). The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients’ experiences, and stakeholders’ experiences of implementation, including influences. ANOVA was used to test differences over time and interventions. Results Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility. Conclusions This was a large, complex study and one of the first national randomised

  17. Does nutritional education improve the risk factors for cardiovascular diseases among elderly patients with type 2 diabetes? A randomized controlled trial based on an educational model.

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    Sharifirad, Gholamreza; Najimi, Arash; Hassanzadeh, Akbar; Azadbakht, Leila

    2013-06-01

    To evaluate the effects of a nutritional education program on cardiovascular risk among elderly patients with type 2 diabetes (T2D). Ninety-seven elderly patients with T2D were enrolled in the present randomized controlled educational trial study. Patients were divided into intervention and control groups. The belief, attitude, subjective norm, enabling factors (BASNEF) educational model was used to design the educational intervention. Patients in the control group received their usual care during the study. Anthropometric data, lipid profiles and blood pressure measurements were collected at baseline and Week 12 in each group. Significant declines were observed in the intervention compared with control group in terms of body weight (-1.3 ± 1.1 vs. 0.11 ± 0.58 kg, respectively), body mass index (-0.48 ± 0.37 vs. 0.05 ± 0.22 kg/m2, respectively), serum triglyceride levels (-18.25 ± 32.15 vs. -3.67 ± 22.61 mg/dL, respectively; P intervention and control groups in terms of high-density lipoprotein-cholesterol (-1.02 ± 4.35 vs. -1.10 ± 6.93 mg/dL, respectively; P = 0.9) or low-density lipoprotein-cholesterol (-4.04 ± 11.64 vs. -1.08 ± 4.35 mg/dL, respectively; P = 0.2). Short-term nutritional education based on the BASNEF educational model improves serum triglyceride levels and anthropometric indices in elderly patients with T2D. © 2012 Wiley Publishing Asia Pty Ltd and Ruijin Hospital, Shanghai Jiaotong University School of Medicine.

  18. A review on cardiovascular effects of newer hypoglycaemic medications.

    Science.gov (United States)

    Cutshall, B Tate; Twilla, Jennifer D; Olinger, Andrew S; Oliphant, Carrie S

    2017-11-01

    Cardiovascular disease (CVD) is the most prevalent cause of morbidity and mortality in diabetic patients. Improvement in cardiovascular complications with glycaemic control and managing cardiovascular risk factors is well established. However, the impact of hypoglycaemic medications on CVD is of increasing importance. In 2008, the U.S. Food and Drug Administration issued study regulations for hypoglycaemic agents after rosiglitazone was shown to increase the incidence of myocardial infarction, and the European Medicines Agency provided their own guidance in 2012. As a result, multiple studies have been published evaluating the cardiovascular safety of newer hypoglycaemic medications. Empagliflozin and liraglutide are among the newer agents that have shown cardiovascular benefit and are now recommended for patients with CVD or are at an increased risk of CVD per the 2017 American Diabetes Association Guidelines. Given the influx of new literature and other ongoing studies, it is important to understand the cardiovascular safety of newer hypoglycaemic medications. The purpose of this article is to provide a comprehensive review of clinical trials conducted evaluating cardiovascular outcomes of newer hypoglycaemic medications and their role within diabetic management. Key Messages With the prevalence of cardiovascular disease in diabetic patients, clinicians should develop a medication regimen that provides both sufficient efficacy for diabetes while also maintaining cardiovascular safety. Of the new diabetic classes, empagliflozin, a sodium-glucose co-transporter 2 inhibitor, and liraglutide, a glucagon-like peptide-1 receptor agonist, have shown cardiovascular benefit in diabetic patients with established cardiovascular disease and are now recommended in current guidelines for this population. Ongoing trials will give more insight to whether cardiovascular benefit is a class effect with sodium-glucose co-transporter 2 inhibitors and glucagon-like peptide-1 receptor

  19. Short and long term effects of a lifestyle intervention for construction workers at risk for cardiovascular disease: A randomized controlled trial

    NARCIS (Netherlands)

    Groeneveld, I.F.; Proper, K.I.; Beek, A.J. van der; Hildebrandt, V.H.; Mechelen, W. van

    2011-01-01

    Background: The prevalence of overweight and elevated cardiovascular disease (CVD) risk among workers in the construction industry is relatively high. Improving lifestyle lowers CVD risk and may have work-related benefits. The purpose of the study was to evaluate the effects on physical activity

  20. The Effect of Probiotic Yogurt on Blood Glucose and cardiovascular Biomarkers in Patients with Type II Diabetes: A Randomized Controlled Trial

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    Mahin Rezaei

    2017-01-01

    Full Text Available Background: Given the high prevalence of type II diabetes and its complications, the evidence regarding the beneficial effects of probiotic yogurt on some cardiovascular biomarkers in diabetic patients is worthy of investigation. Aim: To investigate the effect of probiotic yogurt on blood glucose level and cardiovascular biomarkers in patients with type II diabetes. Method:This randomized, clinical trial was conducted on 90 patients with type II diabetes who visited the 5 Azar diabetes clinic in Gorgan, Iran, in 2014. The intervention group consumed three 100 g packages of probiotic yogurt per day for four weeks, while the control group used an equal amount of plain yogurt. Dietary intake, as well as anthropometric and biochemical parameters were measured before and after the trial. To analyze the data, independent t-test, paired t-test, and analysis of covariance were performed, using SPSS version 18. Results: The mean ages of the intervention and control groups were 50.49±10.92 and 50.13±9.20 years, respectively. In the intervention group, paired t-test showed significant differences between mean levels of blood glucose, cholesterol, low-density lipoprotein (LDL, triglycerides, diastolic blood pressure, and glycated hemoglobin before and after four weeks of daily intake of probiotic yogurt (P0.05. At the end of trial, the independent t-test showed a significant difference between the two groups in terms of mean levels of blood glucose, LDL, triglycerides, blood pressure, and glycated hemoglobin (P

  1. Evaluation of oxidative stress markers and cardiovascular risk factors in Fabry Disease patients

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    Karen B. Müller

    2012-01-01

    Full Text Available Fabry Disease, an X-linked inborn error of metabolism, is characterized by progressive renal insufficiency, with cardio and cerebrovascular involvement. Homocysteine (Hcy is considered a risk factor for vascular diseases, but the mechanisms by which it produces cardiovascular damage are still poorly understood. Regarding the vascular involvement in FD patients, the analysis of factors related to thromboembolic events could be useful to improving our understanding of the disease. The aim of this study was to evaluate plasma Hcy and other parameters involved in the methionine cycle, as well as oxidative stress markers. The sample consisted of a group of 10 male FD patients and a control group of 8 healthy individuals, paired by age. Venous blood was collected for Hcy determination, molecular analysis, identification of thiobarbituric acid reactive substances, total glutathione and antioxidant enzymes activity, as well as vitamins quantification. Comparative analysis of FD patients versus the control group indicated hyperhomocysteinemia in 8 of the 10 FD patients, as well as a significant increase in overall glutathione levels and catalase activity. It is inferred that FD patients, apart from activation of the antioxidant system, present increased levels of plasma Hcy, although this is probably unrelated to common alterations in the methionine cycle.

  2. Progesterone therapy, endothelial function and cardiovascular risk factors: a 3-month randomized, placebo-controlled trial in healthy early postmenopausal women.

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    Jerilynn C Prior

    Full Text Available BACKGROUND: Progesterone is effective treatment for hot flushes/night sweats. The cardiovascular effects of progesterone therapy are unknown but evidence suggests that premenopausal normal estradiol with also normal progesterone levels may provide later cardiovascular protection. We compared the effects of progesterone to placebo on endothelial function, weight, blood pressure, metabolism, lipids, inflammation and coagulation. METHODS AND RESULTS: We conducted a randomized, double-blind, 3-month placebo-controlled trial of progesterone (300 mg daily among 133 healthy postmenopausal women in Vancouver, Canada from 2003-2009. Endothelial function by venous occlusion plethysmography was a planned primary outcome. Enrolled women were 1-11 y since last menstruation, not using hormones (for >6 months, non-smoking, without diabetes, hypertension, heart disease or their medications. Randomized (1∶1 women (55 ± 4 years, body mass index 25 ± 3 initially had normal blood pressure, fasting lipid, glucose and electrocardiogram results. Endothelial function (% forearm blood flow above saline was not changed with progesterone (487 ± 189%, n = 18 compared with placebo (408 ± 278%, n = 16 (95% CI diff [-74 to 232], P = 0.30. Progesterone (n = 65 and placebo (n = 47 groups had similar changes in systolic and diastolic blood pressure, resting heart rate, weight, body mass index, waist circumference, total cholesterol, low-density lipoprotein cholesterol and triglyceride levels. High-density lipoprotein was lower (-0.14 mmol/L, P = 0.001 on progesterone compared with placebo. Fasting glucose, hs-C-reactive protein, albumin and D-dimer changes were all comparable to placebo. Framingham General Cardiovascular Risk Profile scores were initially low and remained low with progesterone therapy and not statistically different from placebo. CONCLUSIONS: Results indicate that progesterone has short-term cardiovascular safety. Endothelial

  3. Low-dose B vitamins supplementation ameliorates cardiovascular risk: a double-blind randomized controlled trial in healthy Chinese elderly.

    Science.gov (United States)

    Wang, Linlin; Li, Hongtian; Zhou, Yuan; Jin, Lei; Liu, Jianmeng

    2015-04-01

    We investigated whether daily supplementation with low-dose B vitamins in the healthy elderly population improves the Framingham risk score (FRS), a predictor of cardiovascular disease risk. Between 2007 and 2012, a double-blind randomized controlled trial was conducted in a rural area of North China. In all, 390 healthy participants aged 60-74 were randomly allocated to receive daily vitamin C (50 mg; control group) or vitamin C plus B vitamins (400 µg folic acid, 2 mg B6, and 10 µg B12; treatment group) for 12 months. FRSs were calculated for all 390 subjects. Folate and vitamin B12 plasma concentrations in the treatment group increased by 253 and 80%, respectively, after 6 months, stopped increasing with continued supplementation after 12 months and returned to baseline levels 6 months after supplementation cessation. Compared with the control group, there was no significant effect of B vitamin supplementation on FRSs after 6 months (mean difference -0.38; 95% CI -1.06, 0.31; p = 0.279), whereas a significant effect of supplementation was evident after 12 months (reduced magnitude 7.6%; -0.77; 95% CI -1.47, -0.06; p = 0.033). However, this reduction disappeared 6 months after supplementation stopped (-0.07; 95% CI -0.80, 0.66; p = 0.855). The reduction in FRS 12 months after supplementation was more pronounced in individuals with a folate deficiency (10.4%; -1.30; 95% CI -2.54, -0.07; p = 0.039) than in those without (4.1%; -0.38; 95% CI -1.12, 0.36; p = 0.313). B vitamins increased high-density lipoprotein cholesterol by 3.4% after 6 months (0.04; 95% CI -0.02, 0.10; p = 0.155) and by 9.2% after 12 months (0.11; 95 % CI 0.04, 0.18; p = 0.003). Compared with the control group, this change in magnitude decreased to 3.3% (0.04; 95 % CI -0.02, 0.10; p = 0.194) 6 months after supplementation cessation. Daily supplementation with a low-dose of B vitamins for 12 months reduced FRS, particularly in healthy elderly subjects with a folate deficiency. These reduced

  4. A health dialogue intervention reduces cardiovascular risk factor levels: a population based randomised controlled trial in Swedish primary care setting with 1-year follow-up

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    Mats Hellstrand

    2017-08-01

    Full Text Available Abstract Background The total number of cardiovascular (CVD deaths accounted for almost a third of all deaths globally in 2013. Population based randomised controlled trials, managed within primary care, on CVD risk factor interventions are scarce. The aim of the study was to evaluate the effects of a health dialogue intervention in a primary care setting offered to a population at the age of 55 years, focusing on CVD risk factors. Methods The study was performed in five primary health care centres in the county of Västmanland, Sweden between April 2011 and December 2012. Men and women were randomly assigned to intervention (n = 440 and control groups (n = 440. At baseline, both groups filled in a health questionnaire and serum cholesterol, fasting plasma glucose, glycated haemoglobin (HbA1c, weight, height, waist (WC and hip circumference, waist hip ratio (WHR and systolic/diastolic blood pressure were measured. Intervention group attended a health dialogue, supported by a visualised health profile, with a possibility for further activities. Participation rates at baseline were 53% and 52% respectively. A 1-year follow-up was carried out. Results The intervention group (n = 165 showed reductions compared to the control group (n = 177 concerning body mass index (BMI (0.3 kg/m2, p = .031, WC (2.1 cm, p ≤ .001 and WHR (.002, p ≤ .001 at the 1-year follow-up. No differences between the intervention and control groups were found in other variables. Intervention group, compared to baseline, had reduced weight, BMI, WC, WHR, HbA1c, and diet, while the men in the control group had reduced their alcohol consumption. Conclusions A health dialogue intervention at the age of 55 years, conducted in ordinary primary care, showed a moderate effect on CVD risk factor levels, in terms of BMI, WC and WHR. Trial registration number BioMed Central, ISRCTN22586871 , date assigned; 10/12/2015

  5. A Randomized Trial on Home Telemonitoring for the Management of Metabolic and Cardiovascular Risk in Patients with Type 2 Diabetes.

    Science.gov (United States)

    Nicolucci, Antonio; Cercone, Stefania; Chiriatti, Alberto; Muscas, Fabrizio; Gensini, Gianfranco

    2015-08-01

    This study evaluated whether a home telehealth (HT) system enabling the patient to monitor body weight, blood glucose values, and blood pressure values, associated with remote educational support and feedback to the general practitioner, can improve metabolic control and overall cardiovascular risk in individuals with type 2 diabetes mellitus, compared with usual practice. This was a randomized, parallel-group (1:1), open-label, multicenter study conducted in general practice. Follow-up was for 12 months. Overall, 29 general practitioners enrolled 302 patients (153 assigned to the HT group and 149 to the control group). Use of the HT system was associated with a statistically significant reduction in glycated hemoglobin (HbA1c) levels compared with the control group (estimated mean difference, 0.33±0.1; P=0.001). No difference emerged as for body weight, blood pressure, and lipid profile. The proportion of patients reaching the target of HbA1c <7.0% was higher in the HT group than in the control group after 6 months (33.0% vs. 18.7%; P=0.009) and 12 months (28.1% vs. 18.5%; P=0.07). As for quality of life (evaluated with the 36-item Short Form health survey), significant differences in favor of the HT group were detected as for physical functioning (P=0.01), role limitations due to emotional problems (P=0.02), mental health (P=0.005), and mental component summary (P=0.03) scores. A lower number of specialist visits was reported in the telemedicine group (incidence rate ratio, 0.72; 95% confidence interval, 0.51-1.01; P=0.06). Use of the HT system was associated with better metabolic control and quality of life; a marginally nonsignificant lower resource utilization was also documented. No impact was documented on blood pressure, lipid profile, and body weight.

  6. Effect of Natriuretic Peptide-Guided Therapy on Hospitalization or Cardiovascular Mortality in High-Risk Patients With Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial.

    Science.gov (United States)

    Felker, G Michael; Anstrom, Kevin J; Adams, Kirkwood F; Ezekowitz, Justin A; Fiuzat, Mona; Houston-Miller, Nancy; Januzzi, James L; Mark, Daniel B; Piña, Ileana L; Passmore, Gayle; Whellan, David J; Yang, Hongqiu; Cooper, Lawton S; Leifer, Eric S; Desvigne-Nickens, Patrice; O'Connor, Christopher M

    2017-08-22

    The natriuretic peptides are biochemical markers of heart failure (HF) severity and predictors of adverse outcomes. Smaller studies have evaluated adjusting HF therapy based on natriuretic peptide levels ("guided therapy") with inconsistent results. To determine whether an amino-terminal pro-B-type natriuretic peptide (NT-proBNP)-guided treatment strategy improves clinical outcomes vs usual care in high-risk patients with HF and reduced ejection fraction (HFrEF). The Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure (GUIDE-IT) study was a randomized multicenter clinical trial conducted between January 16, 2013, and September 20, 2016, at 45 clinical sites in the United States and Canada. This study planned to randomize 1100 patients with HFrEF (ejection fraction ≤40%), elevated natriuretic peptide levels within the prior 30 days, and a history of a prior HF event (HF hospitalization or equivalent) to either an NT-proBNP-guided strategy or usual care. Patients were randomized to either an NT-proBNP-guided strategy or usual care. Patients randomized to the guided strategy (n = 446) had HF therapy titrated with the goal of achieving a target NT-proBNP of less than 1000 pg/mL. Patients randomized to usual care (n = 448) had HF care in accordance with published guidelines, with emphasis on titration of proven neurohormonal therapies for HF. Serial measurement of NT-proBNP testing was discouraged in the usual care group. The primary end point was the composite of time-to-first HF hospitalization or cardiovascular mortality. Prespecified secondary end points included all-cause mortality, total hospitalizations for HF, days alive and not hospitalized for cardiovascular reasons, the individual components on the primary end point, and adverse events. The data and safety monitoring board recommended stopping the study for futility when 894 (median age, 63 years; 286 [32%] women) of the planned 1100 patients had been enrolled with

  7. Evaluation of the educational value of YouTube videos about physical examination of the cardiovascular and respiratory systems.

    Science.gov (United States)

    Azer, Samy A; Algrain, Hala A; AlKhelaif, Rana A; AlEshaiwi, Sarah M

    2013-11-13

    A number of studies have evaluated the educational contents of videos on YouTube. However, little analysis has been done on videos about physical examination. This study aimed to analyze YouTube videos about physical examination of the cardiovascular and respiratory systems. It was hypothesized that the educational standards of videos on YouTube would vary significantly. During the period from November 2, 2011 to December 2, 2011, YouTube was searched by three assessors for videos covering the clinical examination of the cardiovascular and respiratory systems. For each video, the following information was collected: title, authors, duration, number of viewers, and total number of days on YouTube. Using criteria comprising content, technical authority, and pedagogy parameters, videos were rated independently by three assessors and grouped into educationally useful and non-useful videos. A total of 1920 videos were screened. Only relevant videos covering the examination of adults in the English language were identified (n=56). Of these, 20 were found to be relevant to cardiovascular examinations and 36 to respiratory examinations. Further analysis revealed that 9 provided useful information on cardiovascular examinations and 7 on respiratory examinations: scoring mean 14.9 (SD 0.33) and mean 15.0 (SD 0.00), respectively. The other videos, 11 covering cardiovascular and 29 on respiratory examinations, were not useful educationally, scoring mean 11.1 (SD 1.08) and mean 11.2 (SD 1.29), respectively. The differences between these two categories were significant (P.86. A small number of videos about physical examination of the cardiovascular and respiratory systems were identified as educationally useful; these videos can be used by medical students for independent learning and by clinical teachers as learning resources. The scoring system utilized by this study is simple, easy to apply, and could be used by other researchers on similar topics.

  8. Evaluation of dyslipidemia, lipid ratios, and atherogenic index as cardiovascular risk factors among semi-urban dwellers in Nigeria

    Science.gov (United States)

    Olamoyegun, Michael Adeyemi; Oluyombo, Rotimi; Asaolu, Stephen Olabode

    2016-01-01

    Background and Objectives: The increasing frequency of cardiovascular disease (CVD) rests on the presence of major cardiovascular risk factors including dyslipidemia. This dyslipidemia is also a target for the prevention and treatment of many cardiovascular diseases. Hence, identification of individuals at risk of CVD is needed for early identification and prevention. The study was carried out to evaluate dyslipidemia using the lipid ratios and indices instead of just the conventional lipid profile. Methodology: It was a cross-sectional study with 699 participants recruited from semi-urban communities in Nigeria. Anthropometric indices, blood pressure, and fasting lipid profiles were determined. Abnormalities in lipid indices and lipid ratios with atherogenic index were also determined. SPSS software version 17.0 were used for analysis, P < 0.05 was considered statistically significant. Results: There were 699 participants with a mean age of 64.45 ± 15.53 years. Elevated total cholesterol, high low-density lipoprotein-cholesterol, elevated triglyceride, and low high-density lipoprotein were seen in 5.3%, 19.3%, 4.4%, and 76.3% of the participants, respectively. The Castelli's risk index-I (CRI-I) predicted the highest prevalence of predisposition to cardiovascular risk (47.8%) with females being at significantly higher risk (55.2% vs. 29.3%, P < 0.001). Atherogenic coefficient, CRI-II, CHOLIndex, atherogenic index of plasma (AIP) predicted a cardiovascular risk prevalence of 22.5%, 15.9%, 11.2%, and 11.0%, respectively, with no significant difference in between the sexes. Conclusions: Serum lipid ratios and AIP may be used in addition to lipid parameters in clinical practice to assess cardiovascular risks even when lipid profiles are apparently normal. AIP was more gender specific amidst the lipid ratios. PMID:27853034

  9. The Influence of Triclosan on Biomarkers of Cardiovascular Risk in Patients in the Cardiovascular and Periodontal Study (CAPS): A Randomized Controlled Trial.

    Science.gov (United States)

    Cullinan, Mary P; Palmer, Janet E; Faddy, Malcolm J; Westerman, Bill; Carle, Anne D; West, Malcolm J; Seymour, Gregory J

    2015-07-01

    Triclosan toothpaste is effective in controlling plaque and gingivitis and slowing progression of periodontitis; however, its influence on inflammatory biomarkers of cardiovascular disease (CVD), as well as on kidney and liver function, is unknown. Patients recruited from the Cardiovascular Unit at Prince Charles Hospital, Brisbane, Australia, were randomized to triclosan (n = 193) or placebo (n = 190) groups and assessed for total cholesterol (TC), high density lipoprotein (HDL) and low density lipoprotein (LDL) cholesterol, triglycerides, C-reactive protein, erythrocyte sedimentation rate (ESR), hemoglobin, total white cell count (WCC), estimated glomerular filtration rate (eGFR), and liver function enzymes, annually for 5 years. A standard mixed model for each marker included group, sex, age, hypertension, diabetes, periodontal status, statin and anti-inflammatory drug use, and smoking as covariates. Changes in eGFR, WCC, and ESR were further analyzed using transition modeling. Triclosan toothpaste led to a greater decrease in TC (P = 0.03), LDL cholesterol (P = 0.04), and HDL cholesterol (P = 0.05) than placebo toothpaste. ESR increased at a slower rate in the triclosan group (P ≈ 0.06) and was less likely to increase and more likely to improve in males on statins but not anti-inflammatory drugs in the triclosan group versus the placebo group. Markov modeling of the binary response for eGFR (greater than or less than/equal to the baseline median value) showed that patients with diabetes in the placebo group were significantly (P ≈ 0.05) more likely to deteriorate than either patients with diabetes in the triclosan group or patients without diabetes in each group. These data suggest that triclosan toothpaste may influence some inflammatory biomarkers of CVD, but not kidney or liver function. However, it is unclear if this influence is clinically significant.

  10. Process evaluation of a tailored intervention programme of cardiovascular risk management in general practices.

    Science.gov (United States)

    Huntink, E; Wensing, M; Timmers, I M; van Lieshout, J

    2016-12-15

    A tailored implementation programme to improve cardiovascular risk management (CVRM) in general practice had little impact on outcomes. The questions in this process evaluation concerned (1) impact on counselling skills and CVRM knowledge of practice nurses, (2) their use of the various components of the intervention programme and adoption of recommended practices and (3) patients' perceptions of counselling for CVRM. A mixed-methods process evaluation was conducted. We assessed practice nurses' motivational interviewing skills on audio-taped consultations using Motivational Interviewing Treatment Integrity (MITI). They also completed a clinical knowledge test. Both practice nurses and patients reported on their experiences in a written questionnaire and interviews. A multilevel regression analysis and an independent sample t test were used to examine motivational interviewing skills and CVRM knowledge. Framework analysis was applied to analyse qualitative data. Data from 34 general practices were available, 19 intervention practices and 14 control practices. No improvements were measured on motivational interviewing skills in both groups. There appeared to be better knowledge of CVRM in the control group. On average half of the practice nurses indicated that they adopted the recommended interventions, but stated that they did not necessarily record this in patients' medical files. The tailored programme was perceived as too large. Time, follow-up support and reminders were felt to be lacking. About 20% of patients in the intervention group visited the general practice during the intervention period, yet only a small number of these patients were referred to recommended options. The tailored programme was only partly used by practice nurses and had little impact on either their clinical knowledge and communication skills or on patient reported healthcare. If the assumed logical model of change is valid, a more intensive programme is needed to have an impact on CVRM

  11. The Impact of Gender and Protein Intake on the Success of Weight Maintenance and Associated Cardiovascular Risk Benefits, Independent of the Mode of Food Provision: The DiOGenes Randomized Trial.

    Science.gov (United States)

    Navas-Carretero, Santiago; Holst, Claus; Saris, Wim H; van Baak, Marleen A; Jebb, Susan A; Kafatos, Anthony; Papadaki, Angeliki; Pfeiffer, Andreas F H; Handjieva-Darlenska, Teodora; Hlavaty, Petr; Stender, Steen; Larsen, Thomas M; Astrup, Arne; Martinez, J Alfredo

    2016-01-01

    Maintenance of weight loss and associated cardiovascular benefits after following energy-restricted diets is still a challenging field, and thorough investigation is needed. The present research aimed to determine the role of protein and gender in relation to two different intervention models related to food supply, in a weight maintenance trial. The DiOGenes trial was a long-term, multicenter, randomized, dietary intervention study, conducted in eight European countries (Clinical Trials.gov, NCT00390637), focusing on assessing the effectiveness of weight maintenance over 6 months. This secondary analysis intended to evaluate the different benefits for weight maintenance and cardiometabolic markers of two dietary advice delivery models: "shop + instruction intervention" vs "instruction-alone intervention," which were further categorized for gender and macronutrient intake. The weight maintenance intervention based on different macronutrient intake showed, independently of the advice delivery model, in both sexes that higher protein consumption was more effective for weight stability, showing better results in obese women (low protein: 1.65 kg in males and 0.73 Kg in females vs high protein: 1.45 kg in males and -0.93 Kg in females) . Measurements concerning cardiovascular risk markers from subjects on both structured models produced similar trends in the subsequent follow-up period, with a lower rebound in women for most of the markers analyzed. The reported dietary benefits for weight sustainability should be ascribed to the macronutrient distribution (higher protein diets) rather than to the structured mode of delivery. Higher weight regain in males was noted, as well as a metabolic divergence attributable to the sex, with a better biochemical outcome in women.

  12. Randomised controlled trial of a 12 week yoga intervention on negative affective states, cardiovascular and cognitive function in post-cardiac rehabilitation patients.

    Science.gov (United States)

    Yeung, Alan; Kiat, Hosen; Denniss, A Robert; Cheema, Birinder S; Bensoussan, Alan; Machliss, Bianca; Colagiuri, Ben; Chang, Dennis

    2014-10-24

    Negative affective states such as anxiety, depression and stress are significant risk factors for cardiovascular disease, particularly in cardiac and post-cardiac rehabilitation populations.Yoga is a balanced practice of physical exercise, breathing control and meditation that can reduce psychosocial symptoms as well as improve cardiovascular and cognitive function. It has the potential to positively affect multiple disease pathways and may prove to be a practical adjunct to cardiac rehabilitation in further reducing cardiac risk factors as well as improving self-efficacy and post-cardiac rehabilitation adherence to healthy lifestyle behaviours. This is a parallel arm, multi-centre, randomised controlled trial that will assess the outcomes of post- phase 2 cardiac rehabilitation patients assigned to a yoga intervention in comparison to a no-treatment wait-list control group. Participants randomised to the yoga group will engage in a 12 week yoga program comprising of two group based sessions and one self-administered home session each week. Group based sessions will be led by an experienced yoga instructor. This will involve teaching beginner students a hatha yoga sequence that incorporates asana (poses and postures), pranayama (breathing control) and meditation. The primary outcomes of this study are negative affective states of anxiety, depression and stress assessed using the Depression Anxiety Stress Scale. Secondary outcomes include measures of quality of life, and cardiovascular and cognitive function. The cardiovascular outcomes will include blood pressure, heart rate, heart rate variability, pulse wave velocity, carotid intima media thickness measurements, lipid/glucose profiles and C-reactive protein assays. Assessments will be conducted prior to (week 0), mid-way through (week 6) and following the intervention period (week 12) as well as at a four week follow-up (week 16). This study will determine the effect of yoga practice on negative affective states

  13. Re-evaluating the functional landscape of the cardiovascular system during development.

    Science.gov (United States)

    Takada, Norio; Omae, Madoka; Sagawa, Fumihiko; Chi, Neil C; Endo, Satsuki; Kozawa, Satoshi; Sato, Thomas N

    2017-11-15

    The cardiovascular system facilitates body-wide distribution of oxygen, a vital process for the development and survival of virtually all vertebrates. However, the zebrafish, a vertebrate model organism, appears to form organs and survive mid-larval periods without a functional cardiovascular system. Despite such dispensability, it is the first organ to develop. Such enigma prompted us to hypothesize other cardiovascular functions that are important for developmental and/or physiological processes. Hence, systematic cellular ablations and functional perturbations were performed on the zebrafish cardiovascular system to gain comprehensive and body-wide understanding of such functions and to elucidate the underlying mechanisms. This approach identifies a set of organ-specific genes, each implicated for important functions. The study also unveils distinct cardiovascular mechanisms, each differentially regulating their expressions in organ-specific and oxygen-independent manners. Such mechanisms are mediated by organ-vessel interactions, circulation-dependent signals, and circulation-independent beating-heart-derived signals. A comprehensive and body-wide functional landscape of the cardiovascular system reported herein may provide clues as to why it is the first organ to develop. Furthermore, these data could serve as a resource for the study of organ development and function. © 2017. Published by The Company of Biologists Ltd.

  14. Usefulness of multidetector-row computed tomography (MD-CT) for diagnosis and evaluation of cardiovascular anomalies in infants

    International Nuclear Information System (INIS)

    Kani, Hiroyuki; Narabayashi, Isamu; Tanikake, Masato; Matsuki, Mitsuru; Uesugi, Yasuo

    2005-01-01

    We examined the effectiveness of multidetector-row CT (MD-CT) in the diagnosis and evaluation of cardiovascular anomalies in infants. MD-CT was performed 34 times on 21 patients with cardiovascular anomalies. We performed three evaluations: 1) The assessment of the specificity of MD-CT in detecting the morphological features of cardiovascular anomalies. 2) The diameters of aortae with coronary artery (CoA), and the diameters of pulmonary artery, measured by using MD-CT were compared with those by angiography. 3) The amount of exposure to radiation was measured. 1) MD-CT can detect CoA, pulmonary arteriovenous anomalies among extracardiac anomalies in all the patients. The diagnostic accuracy for intracardiac anomalies was poor as only six of the 15 anomalies could be accurately diagnosed. 2) The diameters of aortae and pulmonary artery obtained using MD-CT showed a good correlation with those obtained using arteriography (r=0.97, 0.95). 3) The average dose-length product was 269.2 mGy·cm. And the average effective dose was 5.1 mSv. MD-CT is not suitable for the evaluation of intracardiac anomalies, but is extremely effective in the evaluation of extracardiac major vascular anomalies. On the basis of the amount of information and noninvasive nature, MD-CT should be used first before angiography. (author)

  15. Clarithromycin for stable coronary heart disease increases all-cause and cardiovascular mortality and cerebrovascular morbidity over 10years in the CLARICOR randomised, blinded clinical trial

    DEFF Research Database (Denmark)

    Winkel, Per; Hilden, Jørgen; Hansen, Jørgen Fischer

    2015-01-01

    -cause mortality (hazard ratio (HR): 1.10, 95% confidence interval (CI): 1.00-1.21) and cerebrovascular disease during 10years (HR: 1.19, 95% CI: 1.02-1.38). The increased mortality and morbidity were restricted to patients not on statin at entry (HR: 1.16, 95% CI: 1.04-1.31, and HR: 1.25, 95% CI: 1...... death outside hospital and cerebrovascular morbidity in patients with stable coronary heart disease who were not on statin. The increased cardiovascular mortality was years later compensated, likely through frailty attrition.......BACKGROUND: The CLARICOR trial reported that clarithromycin compared with placebo increased all-cause mortality in patients with stable coronary heart disease. This study investigates the effects of clarithromycin versus placebo during 10years follow up. METHODS: The CLARICOR trial is a randomised...

  16. Reduction in cardiovascular risk using a proactive multifactorial intervention is consistent among patients residing in Pacific Asian and non-Pacific Asian regions: a CRUCIAL trial subanalysis

    Directory of Open Access Journals (Sweden)

    Cho EJ

    2014-03-01

    Full Text Available Eun Joo Cho,1 Jae Hyung Kim,1 Santosh Sutradhar,2 Carla Yunis,2 Mogens Westergaard2On behalf of the CRUCIAL trial investigators1Department of Cardiology, St Paul's Hospital, The Catholic University of Korea, Seoul, Korea; 2Pfizer Inc., New York, NY, USABackground: Few trials have compared different approaches to cardiovascular disease prevention among Pacific Asian (PA populations. The Cluster Randomized Usual Care versus Caduet Investigation Assessing Long-term-risk (CRUCIAL trial demonstrated that a proactive multifactorial intervention (PMI approach (based on single-pill amlodipine/atorvastatin resulted in a greater reduction in calculated Framingham 10-year coronary heart disease (CHD risk compared with usual care (UC among hypertensive patients with additional risk factors. One-third of CRUCIAL patients resided in the PA region. The aim of this subanalysis was to compare two approaches to cardiovascular risk factor management (PMI versus UC among patients residing in PA and non-PA regions.Methods: This subanalysis of the CRUCIAL trial compared treatment-related changes in calculated CHD risk among patients residing in PA and non-PA regions. Sensitivity analyses were conducted among men and women and those with and without diabetes.Results: Overall, 448 patients (31.6% resided in the PA region and 969 patients (68.4% resided in non-PA regions. The PMI approach was more effective in reducing calculated CHD risk versus UC in both PA (−37.1% versus −3.5%; P<0.001 and non-PA regions (−31.1% versus −4.2%; P<0.001; region interaction P=0.131. PA patients had slightly greater reductions in total cholesterol compared with non-PA patients. PA patients without diabetes had slightly greater reductions in CHD risk compared with non-PA patients. Treatment effects were similar in men and women and those with diabetes.Conclusion: The PMI approach was more effective in reducing calculated Framingham 10-year CHD risk compared with UC among men and

  17. Combined task delegation, computerized decision support, and feedback improve cardiovascular risk for type 2 diabetic patients: a cluster randomized trial in primary care.

    Science.gov (United States)

    Cleveringa, Frits G W; Gorter, Kees J; van den Donk, Maureen; Rutten, Guy E H M

    2008-12-01

    The Diabetes Care Protocol combines task delegation (a practice nurse), computerized decision support, and feedback every 3 months. We studied the effect of the Diabetes Care Protocol on A1C and cardiovascular risk factors in type 2 diabetic patients in primary care. In a cluster randomized trial, mean changes in cardiovascular risk factors between the intervention and control groups after 1 year were calculated by generalized linear models. Throughout the Netherlands, 26 intervention practices included 1,699 patients and 29 control practices 1,692 patients. The difference in A1C change was not significant, whereas total cholesterol, LDL cholesterol, and blood pressure improved significantly more in the intervention group. The 10-year coronary heart disease risk estimate of the UK Prospective Diabetes Study improved 1.4% more in the intervention group. Delegation of routine diabetes care to a practice nurse combined with computerized decision support and feedback did not improve A1C but reduced cardiovascular risk in type 2 diabetes patients.

  18. Weight-of-evidence evaluation of short-term ozone exposure and cardiovascular effects.

    Science.gov (United States)

    Goodman, Julie E; Prueitt, Robyn L; Sax, Sonja N; Lynch, Heather N; Zu, Ke; Lemay, Julie C; King, Joseph M; Venditti, Ferdinand J

    2014-10-01

    There is a relatively large body of research on the potential cardiovascular (CV) effects associated with short-term ozone exposure (defined by EPA as less than 30 days in duration). We conducted a weight-of-evidence (WoE) analysis to assess whether it supports a causal relationship using a novel WoE framework adapted from the US EPA's National Ambient Air Quality Standards causality framework. Specifically, we synthesized and critically evaluated the relevant epidemiology, controlled human exposure, and experimental animal data and made a causal determination using the same categories proposed by the Institute of Medicine report Improving the Presumptive Disability Decision-making Process for Veterans ( IOM 2008). We found that the totality of the data indicates that the results for CV effects are largely null across human and experimental animal studies. The few statistically significant associations reported in epidemiology studies of CV morbidity and mortality are very small in magnitude and likely attributable to confounding, bias, or chance. In experimental animal studies, the reported statistically significant effects at high exposures are not observed at lower exposures and thus not likely relevant to current ambient ozone exposures in humans. The available data also do not support a biologically plausible mechanism for CV effects of ozone. Overall, the current WoE provides no convincing case for a causal relationship between short-term exposure to ambient ozone and adverse effects on the CV system in humans, but the limitations of the available studies preclude definitive conclusions regarding a lack of causation. Thus, we categorize the strength of evidence for a causal relationship between short-term exposure to ozone and CV effects as "below equipoise."

  19. Weight-of-evidence evaluation of long-term ozone exposure and cardiovascular effects.

    Science.gov (United States)

    Prueitt, Robyn L; Lynch, Heather N; Zu, Ke; Sax, Sonja N; Venditti, Ferdinand J; Goodman, Julie E

    2014-10-01

    We conducted a weight-of-evidence (WoE) analysis to assess whether the current body of research supports a causal relationship between long-term ozone exposure (defined by EPA as at least 30 days in duration) at ambient levels and cardiovascular (CV) effects. We used a novel WoE framework based on the United States Environmental Protection Agency's National Ambient Air Quality Standards causal framework for this analysis. Specifically, we critically evaluated and integrated the relevant epidemiology and experimental animal data and classified a causal determination based on categories proposed by the Institute of Medicine's 2008 report, Improving the Presumptive Disability Decision-making Process for Veterans. We found that the risks of CV effects are largely null across human and experimental animal studies. The few positive associations reported in studies of CV morbidity and mortality are very small in magnitude, mainly reported in single-pollutant models, and likely attributable to bias, chance, or confounding. The few positive effects in experimental animal studies were observed mainly in ex vivo studies at high exposures, and even the in vivo findings are not likely relevant to humans. The available data also do not support a biologically plausible mechanism for the effects of ozone on the CV system. Overall, the current WoE provides no convincing case for a causal relationship between long-term exposure to ambient ozone and adverse effects on the CV system in humans, but the limitations of the available studies preclude definitive conclusions regarding a lack of causation; thus, we categorize the strength of evidence for a causal relationship between long-term exposure to ozone and CV effects as "below equipoise."

  20. Unravelling effectiveness of a nurse-led behaviour change intervention to enhance physical activity in patients at risk for cardiovascular disease in primary care: study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Westland, Heleen; Bos-Touwen, Irene D; Trappenburg, Jaap C A; Schröder, Carin D; de Wit, Niek J; Schuurmans, Marieke J

    2017-02-22

    Self-management interventions are considered effective in patients with chronic disease, but trials have shown inconsistent results, and it is unknown which patients benefit most. Adequate self-management requires behaviour change in both patients and health care providers. Therefore, the Activate intervention was developed with a focus on behaviour change in both patients and nurses. The intervention aims for change in a single self-management behaviour, namely physical activity, in primary care patients at risk for cardiovascular disease. The aim of this study is to evaluate the effectiveness of the Activate intervention. A two-arm cluster randomised controlled trial will be conducted to compare the Activate intervention with care as usual at 31 general practices in the Netherlands. Approximately 279 patients at risk for cardiovascular disease will participate. The Activate intervention is developed using the Behaviour Change Wheel and consists of 4 nurse-led consultations in a 3-month period, integrating 17 behaviour change techniques. The Behaviour Change Wheel was also applied to analyse what behaviour change is needed in nurses to deliver the intervention adequately. This resulted in 1-day training and coaching sessions (including 21 behaviour change techniques). The primary outcome is physical activity, measured as the number of minutes of moderate to vigorous physical activity using an accelerometer. Potential effect modifiers are age, body mass index, level of education, social support, depression, patient-provider relationship and baseline number of minutes of physical activity. Data will be collected at baseline and at 3 months and 6 months of follow-up. A process evaluation will be conducted to evaluate the training of nurses, treatment fidelity, and to identify barriers to and facilitators of implementation as well as to assess participants' satisfaction. To increase physical activity in patients and to support nurses in delivering the intervention

  1. Task shifting of frontline community health workers for cardiovascular risk reduction: design and rationale of a cluster randomised controlled trial (DISHA study) in India.

    Science.gov (United States)

    Jeemon, Panniyammakal; Narayanan, Gitanjali; Kondal, Dimple; Kahol, Kashvi; Bharadwaj, Ashok; Purty, Anil; Negi, Prakash; Ladhani, Sulaiman; Sanghvi, Jyoti; Singh, Kuldeep; Kapoor, Deksha; Sobti, Nidhi; Lall, Dorothy; Manimunda, Sathyaprakash; Dwivedi, Supriya; Toteja, Gurudyal; Prabhakaran, Dorairaj

    2016-03-15

    Effective task-shifting interventions targeted at reducing the global cardiovascular disease (CVD) epidemic in low and middle-income countries (LMICs) are urgently needed. DISHA is a cluster randomised controlled trial conducted across 10 sites (5 in phase 1 and 5 in phase 2) in India in 120 clusters. At each site, 12 clusters were randomly selected from a district. A cluster is defined as a small village with 250-300 households and well defined geographical boundaries. They were then randomly allocated to intervention and control clusters in a 1:1 allocation sequence. If any of the intervention and control clusters were baseline cross-sectional survey, development of a structured intervention model, delivery of intervention for a minimum period of 18 months by trained frontline health workers (mainly Anganwadi workers and ASHA workers) and a post intervention survey in a representative sample. The study staff had no information on intervention allocation until the completion of the baseline survey. In order to ensure comparability of data across sites, the DISHA study follows a common protocol and manual of operation with standardized measurement techniques. Our study is the largest community based cluster randomised trial in low and middle-income country settings designed to test the effectiveness of 'task shifting' interventions involving frontline health workers for cardiovascular risk reduction. CTRI/2013/10/004049 . Registered 7 October 2013.

  2. Evaluation of bad habits as risk factors for cardiovascular diseases in Sarajevo Canton

    Directory of Open Access Journals (Sweden)

    Suada Branković

    2012-04-01

    Full Text Available Introduction: Cardiovascular diseases by its frequency, epidemic expenditure, socio-medical consequences and with high mortality are becoming the biggest problem of modern medicine. Mortality from cardiovascular diseases declines due to prevention measures in developed countries, in developing countries and countries in transition it increases. The aim of this study was to determine the prevalence of harmful habits and connection as a risk factor for cardiovascular disease in economically active population in the Canton of Sarajevo.Methods: The study was conducted among the active population of Sarajevo Canton. Randomly selected 443 respondents from different groups of workers aged 18-65 years, who voluntarily joined the study. Weperformed a study intersection descriptive method of research. Instrument for conducting research was a set of questionnaires, designed for research purposes.Results: The results study showed that the study group, current smokers occupy 45%, 1.8% occasional smokers who smoke and the rest of nonsmokers. It was shown that subjects who consume alcohol in biggestpercentage 73.4% consumed the same day, while the smallest percentage 2.7% comprise the same subjects who consumed annually.Conclusions: The prevalence of harmful habits as risk factors for cardiovascular disease among subjects in the Sarajevo Canton is evident represented. It is a significant development of the country, because it affects the health promotion strategy, which consequently changes the behavior based on individual needs. Health education and promotion of health can be reduced or completely prevented by a number of risk factors for cardiovascular disease.

  3. Canadian-led capacity-building in biostatistics and methodology in cardiovascular and diabetes trials: the CANNeCTIN Biostatistics and Methodological Innovation Working Group

    Directory of Open Access Journals (Sweden)

    Pullenayegum Eleanor

    2011-02-01

    Full Text Available Abstract The Biostatistics and Methodological Innovation Working (BMIW Group is one of several working groups within the CANadian Network and Centre for Trials INternationally (CANNeCTIN. This programme received funding from the Canadian Institutes of Health Research and the Canada Foundation for Innovation beginning in 2008, to enhance the infrastructure and build capacity for large Canadian-led clinical trials in cardiovascular diseases (CVD and diabetes mellitus (DM. The overall aims of the BMIW Group's programme within CANNeCTIN, are to advance biostatistical and methodological research, and to build biostatistical capacity in CVD and DM. Our program of research and training includes: monthly videoconferences on topical biostatistical and methodological issues in CVD/DM clinical studies; providing presentations on methods issues at the annual CANNeCTIN meetings; collaborating with clinician investigators on their studies; training young statisticians in biostatistics and methods in CVD/DM trials and organizing annual symposiums on topical methodological issues. We are focused on the development of new biostatistical methods and the recruitment and training of highly qualified personnel - who will become leaders in the design and analysis of CVD/DM trials. The ultimate goal is to enhance global health by contributing to efforts to reduce the burden of CVD and DM.

  4. Including pork in the Mediterranean diet for an Australian population: Protocol for a randomised controlled trial assessing cardiovascular risk and cognitive function.

    Science.gov (United States)

    Wade, Alexandra T; Davis, Courtney R; Dyer, Kathryn A; Hodgson, Jonathan M; Woodman, Richard J; Keage, Hannah A D; Murphy, Karen J

    2017-12-22

    The Mediterranean diet is characterised by the high consumption of extra virgin olive oil, fruits, vegetables, grains, legumes and nuts; moderate consumption of fish, poultry, eggs and dairy; and low consumption of red meat and sweets. Cross sectional, longitudinal and intervention studies indicate that a Mediterranean diet may be effective for the prevention of cardiovascular disease and dementia. However, previous research suggests that an Australian population may find red meat restrictions difficult, which could affect long term sustainability of the diet. This paper outlines the protocol for a randomised controlled trial that will assess the cardiovascular and cognitive benefits of a Mediterranean diet modified to include 2-3 weekly serves of fresh, lean pork. A 24-week cross-over design trial will compare a modified Mediterranean diet with a low-fat control diet in at-risk men and women. Participants will follow each of the two diets for 8 weeks, with an 8-week washout period separating interventions. Home measured systolic blood pressure will be the primary outcome measure. Secondary outcomes will include body mass index, body composition, fasting blood lipids, C-reactive protein, fasting plasma glucose, fasting serum insulin, erythrocyte fatty acids, cognitive function, psychological health and well-being, and dementia risk. To our knowledge this research is the first to investigate whether an alternate source of protein can be included in the Mediterranean diet to increase sustainability and feasibility for a non-Mediterranean population. Findings will be significant for the prevention of cardiovascular disease and age-related decline, and may inform individuals, clinicians and public health policy. ACTRN12616001046493 . Registered 5 August 2016.

  5. Triglycerides and cardiovascular disease

    DEFF Research Database (Denmark)

    Nordestgaard, Børge G; Varbo, Anette

    2014-01-01

    cholesterol might not cause cardiovascular disease as originally thought has now generated renewed interest in raised concentrations of triglycerides. This renewed interest has also been driven by epidemiological and genetic evidence supporting raised triglycerides, remnant cholesterol, or triglyceride......-rich lipoproteins as an additional cause of cardiovascular disease and all-cause mortality. Triglycerides can be measured in the non-fasting or fasting states, with concentrations of 2-10 mmol/L conferring increased risk of cardiovascular disease, and concentrations greater than 10 mmol/L conferring increased risk...... of acute pancreatitis and possibly cardiovascular disease. Although randomised trials showing cardiovascular benefit of triglyceride reduction are scarce, new triglyceride-lowering drugs are being developed, and large-scale trials have been initiated that will hopefully provide conclusive evidence...

  6. Healthy Ageing Through Internet Counselling in the Elderly: the HATICE randomised controlled trial for the prevention of cardiovascular disease and cognitive impairment.

    Science.gov (United States)

    Richard, Edo; Jongstra, Susan; Soininen, Hilkka; Brayne, Carol; Moll van Charante, Eric P; Meiller, Yannick; van der Groep, Bram; Beishuizen, Cathrien R L; Mangialasche, Francesca; Barbera, Mariagnese; Ngandu, Tiia; Coley, Nicola; Guillemont, Juliette; Savy, Stéphanie; Dijkgraaf, Marcel G W; Peters, Ron J G; van Gool, Willem A; Kivipelto, Miia; Andrieu, Sandrine

    2016-06-10

    Cardiovascular disease and dementia share a number of risk factors including hypertension, hypercholesterolaemia, smoking, obesity, diabetes and physical inactivity. The rise of eHealth has led to increasing opportunities for large-scale delivery of prevention programmes encouraging self-management. The aim of this study is to investigate whether a multidomain intervention to optimise self-management of cardiovascular risk factors in older individuals, delivered through an coach-supported interactive internet platform, can improve the cardiovascular risk profile and reduce the risk of cardiovascular disease and cognitive decline. HATICE is a multinational, multicentre, prospective, randomised, open-label blinded end point (PROBE) trial with 18 months intervention. Recruitment of 2600 older people (≥65 years) at increased risk of cardiovascular disease will take place in the Netherlands, Finland and France. Participants randomised to the intervention condition will have access to an interactive internet platform, stimulating self-management of vascular risk factors, with remote support by a coach. Participants in the control group will have access to a static internet platform with basic health information.The primary outcome is a composite score based on the average z-score of the difference between baseline and 18 months follow-up values of systolic blood pressure, low-density-lipoprotein and body mass index. Main secondary outcomes include the effect on the individual components of the primary outcome, the effect on lifestyle-related risk factors, incident cardiovascular disease, mortality, cognitive functioning, mood and cost-effectiveness. The study was approved by the medical ethics committee of the Academic Medical Center in Amsterdam, the Comité de Protection des Personnes Sud Ouest et Outre Mer in France and the Northern Savo Hospital District Research Ethics Committee in Finland.We expect that data from this study will result in a manuscript

  7. A Path Analysis of a Randomized "Promotora de Salud" Cardiovascular Disease-Prevention Trial among At-Risk Hispanic Adults

    Science.gov (United States)

    de Heer, Hendrik Dirk; Balcazar, Hector G.; Castro, Felipe; Schulz, Leslie

    2012-01-01

    This study assessed effectiveness of an educational community intervention taught by "promotoras de salud" in reducing cardiovascular disease (CVD) risk among Hispanics using a structural equation modeling (SEM) approach. Model development was guided by a social ecological framework proposing CVD risk reduction through improvement of…

  8. Varespladib and cardiovascular events in patients with an acute coronary syndrome: the VISTA-16 randomized clinical trial

    NARCIS (Netherlands)

    Nicholls, Stephen J.; Kastelein, John J. P.; Schwartz, Gregory G.; Bash, Dianna; Rosenson, Robert S.; Cavender, Matthew A.; Brennan, Danielle M.; Koenig, Wolfgang; Jukema, J. Wouter; Nambi, Vijay; Wright, R. Scott; Menon, Venu; Lincoff, A. Michael; Nissen, Steven E.; Hennekens, Charles; Brown, W. Virgil; DeMets, David; Pfeffer, Marc; Roleau, John; Abraham, JoEllyn; Gebel, James; Huff, Christopher; Katzan, Irene; Shishehbor, Medhi; Rassi, Andrew; Uchino, Ken; Vest, Amanda; Zishiri, Edwin; Heckman, Mary Jo; Balog, Craig; Dart, Anthony; Amerena, John; Prasad, Challa; Farshid, Ahmad; Gunalingam, Brendan; Thompson, Peter; Collins, Nicholas; Arstall, Margaret; van Gaal, William; Aroney, Con; Mahar, Leo; Youssef, George; Horowitz, John; Anand, Dharmesh; Rodes-Cabau, Josep; Polasek, Petr; Lai, Christopher; Huynh, Thao; Hubacek, Jaroslav; Kokis, Andre; Paradis, Jean-Michel; Mukherjee, Ashok; Senaratne, Manohara; Constance, Christian; Gosselin, Gilbert; Lavi, Shahar; Parker, John; Zadra, Remo; Abramson, Beth; Della-Siega, Anthony; Spinar, Jindrich; Pudil, Radek; Motovska, Zuzana; Maly, Martin; Hutyra, Martin; Pleva, Leos; Mayer, Otto; Semenka, Jiri; Klimovic, Tomas; Horak, David; Cervinka, Pavel; Klimsa, Zdenek; Hulinsky, Vaclav; Reichert, Petr; Monhart, Zdenek; Rotterova, Helena; Kobulia, Bondo; Shaburishvili, Tamaz; Mamatsashvili, Merab; Chapidze, Gulnara; Chumburidze, Vakhtang; Megreladze, Irakli; Khintibidze, Irakli; Leithäuser, Boris; Voehringer, Hans-Friedrich; Wachter, Rolf; Nogai, Klaus; Lapp, Harald; Haltern, Georg; Gielen, Stephan; Dorsel, Thomas; Möllmann, Helge; Stellbrink, Christoph; Hengstenberg, Christian; Dengler, Thomas; Heuer, Hubertus; Kreuzer, Joerg; Leschke, Matthias; Mudra, Harald; Werner, Nikos; Braun-Dullaeus, Ruediger; Rosenberg, Mark; Frey, Norbert; Strasser, Ruth; Genth-Zotz, Sabine; Kiss, Robert; Nagy, Andras; Kovacs, Zsolt; Csapo, Kalman; Edes, Istvan; Sereg, Matyas; Vertes, Andras; Ronaszeki, Aladar; Kancz, Sandor; Benczur, Bela; Polgar, Peter; Muller, Gabor; Simonyi, Gabor; Dezsi, Csaba; Merkely, Bela; Dinnyes, Jozsef; Lupkovics, Geza; Kahali, Dhiman; Banker, Darshan; Trivedi, Shailendra; Rajput, Rajeeve; Premchand, Rajendra; Dani, Sameer; Vadaganelli, Prakash; Gupta, Sandeep; Chandra, Sarat; Fulwani, Mahesh; Chawla, Kamaldeep; Parikh, Keyur; Prati, Francesco; Speciale, Giulio; Valgimigli, Marco; Suriano, Patrizia; Berni, Andrea; Sangiorgi, Giuseppe; Fineschi, Massimo; Merenda, Raffaele; Marenzi, Giancarlo; Berti, Sergio; Corrada, Elena; Cuccia, Claudio; Testa, Roberto; Moretti, Luciano; Mennuni, Mauro; Biasucci, Luigi Marzio; Lioy, Ernesto; Auguadro, Carla; Magagnini, Enrico; Fedele, Francesco; Piscione, Federico; Azar, Rabih; Trip, Mieke D.; Liem, Anho; den Hartoog, Maarten; Lenderink, Timo; van de Wetering, Machiel L. J. M.; Lok, Dirk; Oei, Fanny; Tans, Jan Geert; Ilmer, Ben; Keijzers, Mitran; Monraats, Pascalle; Kedhi, Elvin; Breedveld, Rob W.; Herrman, J. P. R.; van Wijk, L. M.; Ronner, Eelko; Nierop, Peter; Bosschaert, Mike; Hermans, Walter; Doevendans, Pieter; Troquay, Roland; van der Heijden, Rob; Veen, Gerrit; Bokern, Marcel J. J. A.; Bronzwaer, Patrick N. A.; Kie, Salem Hong; den Hartog, Frank; Elliott, John; Wilkins, Gerard; Hart, Hamish; Devlin, Gerard; Harding, Scott; Ponikowski, Piotr; Madej, Andrzej; Kochmanski, Marek; Witkowski, Adam; Pluta, Wladyslaw; Bronisz, Marek; Kornacewicz-Jach, Zdzislawa; Wysokinski, Andrzej; Ujda, Marek; Drozdz, Jaroslaw; Derlaga, Boguslaw; Gessek, Jacek; Dabrowski, Marek; Miekus, Pawel; Kozlowski, Artur; Gniot, Jacek; Musial, Wlodzimierz; Dobrzycki, Slawomir; Rynkiewicz, Andrzej; Psuja, Piotr; Rekosz, Jerzy; Drzewiecki, Andrzej; Kuznetsov, Vadim; Gordeev, Ivan; Goloshchekin, Boris; Markov, Valentin; Barbarich, Vladimir; Belenky, Dmitry; Mikhin, Vadim; Volkova, Emilia; Timofeev, Aleksandr; Ermoshkina, Liudmila; Barbarash, Olga; Klein, Garry; Libis, Roman; Vishnevsky, Aleksander; Linev, Kirill; Khaisheva, Larisa; Ruda, Mikhail; Dovgalevskiy, Yakov; Shvarts, Yury; Zateyshchikov, Dmitry; Kostenko, Victor; Shalnev, Vladimir; Simanenkov, Vladimir; Arkhipov, Mikhail; Ovcharenko, Elena; Guseva, Galina; Akhunova, Svetlana; Ortiz, Antonio Ignacio Fernández; Navarro, Manuel Jiménez; Romero, Antonio Jose Fernández; Goya, Iñaki Lekuona; Peñaranda, Antoni Serra; Cendon, Antonio Amaro; Rubio, Antoni Martinez; Zubiri, José Julián Berrade; Soriano, Francisco Ridocci; Sanz, Rafael Rubio; Genís, Antonio Bayés; Lago, Vicente Nieto; Fernández, José Díaz; Romo, Andrés Iñiguez; Franco, Silvestre Nicolás; Martin, Isabel Hernandez; Montero, Juan Sala; Martin, Manuel de Mora; González, Martín Jesús García; Antolin, José Maria Serrano; Areses, Esteban López de Sá; Miranda, Jesús Martín; Alonso-Pulpón, Luís; Esquivias, Gonzalo Barón; Jarne, Elena Fernández; Cortés, José Manuel Gutiérrez; Pérez, Maurice Batlle; Gormaz, Carlos Lafuente; Alegret, Jose Maria; Nava, José Sergio Hevia; Ingelmo, Juan Manuel Grande; Urbano, Rafael Hidalgo; Sanmartín, Marcelo; Katerenchuk, Oleksandr; Vakaliuk, Igor; Karpenko, Oleksandr; Prokhorov, Oleksandr; Koval, Olena; Faynyk, Andriy; Kopytsya, Mykola; Karpenko, Yuriy; Kraiz, Igor; Feskov, Olexander; Rudenko, Leonid; Kozhukhov, Sergii; Goloborodko, Borys; Rivera, Ernesto; Broadwater, Stephen; Crowley, Stephen; Vijay, Nampalli; Goswami, Rajiv; Ferrier, L. Norman; Blanchard, Arnoux; McCullum, Kevin; Chernick, Richard; Bertolet, Barry; Battaglia, Joseph; Richardson, John; Lochridge, Stanley; Lieberman, Scott; Amkieh, Ali; Cavender, James Bradley; Denning, Stephen; Treasure, Charles; Kmetzo, James; Stillabower, Michael; Brilakis, Emmanouil; Schwartz, Gregory; Acheatel, Roger; Kukuy, Eugene; Ashchi, Majdi; Skelding, Kimberly; Martin, Lisa; Gillespie, Eve; French, William; Pollock, Stewart; Polk, Donna; Black, Robert; Drenning, David; Anderson, Jerome; Sanz, Mark; Korban, Elie; Wiley, Mark; Rezkalla, Shereif; Minisi, Anthony; Shah, Ahmed; Silverman, Paul; Amlani, Mohamadali; Eaton, Gregory; Brown, Alan; Jay, Desmond; Loussararian, Arthur; Lamas, Gervasio; Lauer, Michael; Williams, Jerome; Asfour, Abedelrahim; Runquist, Lars; Robertson, Roy; Blonder, Ronald; Davies, Crispin; Downes, Thomas; Chronos, Nicolas; Marso, Steve; Haldis, Thomas; Eich, David; Ahmed, Mudassar; East, Cara; MacDonald, Lee; Seigel, Paul; White, Michael; Camp, Alan; Kleiman, Neal; Burtt, Douglas; Strain, Janet; Go, Brian; Henry, Phillip; Sultan, Parvez; Delafontaine, Patrice; Kashou, Hisham; Lambert, Charles; Movahed, M. Reza; Saucedo, Jorge; Thadani, Udho; Chandrashekhar, Yellapraguda; Lu, David; Chandna, Harish; Mann, James; Ramaswamy, Geetha; Browne, Kevin; Janik, Matthew; Cannon, Kevin; Tolerico, Paul

    2014-01-01

    Secretory phospholipase A2 (sPLA2) generates bioactive phospholipid products implicated in atherosclerosis. The sPLA2 inhibitor varespladib has favorable effects on lipid and inflammatory markers; however, its effect on cardiovascular outcomes is unknown. To determine the effects of sPLA2 inhibition

  9. Evaluating the Impact of a Brief Artistic Intervention on Cardiovascular Recovery from Acute Stress

    Science.gov (United States)

    Keogh, Katharina; Creaven, Ann-Marie

    2017-01-01

    In this study we tested whether drawing and coloring influence cardiovascular recovery and perceived stress following exposure to a stressor. In a mixed experimental design, participants (N = 62) completed an acute stress task before being randomly assigned to one of three brief activities: free-form drawing (full creative control), coloring…

  10. Evaluation of HeartSmarts, a Faith-Based Cardiovascular Health Education Program.

    Science.gov (United States)

    Tettey, Naa-Solo; Duran, Pedro A; Andersen, Holly S; Boutin-Foster, Carla

    2017-02-01

    In order to effectively address cardiovascular disease among African Americans, evidence-based health information must be disseminated within a context aligned with the values and beliefs of the population. Faith-based organizations play a critical role in meeting the religious and spiritual needs of many African Americans. Additionally, faith-based organizations can be effective in health promotion. A manual was created by incorporating biblical scriptures relating to health messages drawn from existing health manuals oriented toward African Americans. Lay health educators active in their churches participated in a 12-week training to learn the basics of cardiovascular disease and methods for delivering the program to their congregations' members. After the completion of the training, these lay health educators recruited participants from their respective churches and administered their own 12-week HeartSmarts program. Measurements of participants' systolic and diastolic blood pressure (mmHg), height (in.), weight (lbs.), and waist circumference (in.) were taken, and cardiovascular disease knowledge assessments (based on 20 open-ended questions) were administered at the start and end of the 12-week programs. Fourteen predominantly African American churches in NYC participated. Of the 221 participants, 199 completed the program. There were significant reductions in pretest and posttest total participant averages for systolic BP (4.48 mmHg, p health assessment scores had an average increase of 12.74 correct responses (p health messages and reducing cardiovascular risk among African Americans.

  11. Cardiovascular magnetic resonance in the evaluation of heart failure: a luxury or a need?

    Science.gov (United States)

    D'Andrea, Antonello; Fontana, Marianna; Cocchia, Rosangela; Scarafile, Raffaella; Calabrò, Raffaele; Moon, James C

    2012-01-01

    Heart failure is a common syndrome with multiple causes. Cardiovascular magnetic resonance (CMR), using the available range of technique, is establishing itself as the gold standard noninvasive test for determining the underlying causes, and adding prognostic value, guiding therapy. Progress is continuing and rapid with promising new techniques such as diffuse fibrosis assessment. This article discusses the diverse roles of CMR in heart failure.

  12. Evaluation of cardiovascular disease risk factors in patients with mycosis fungoides*

    Science.gov (United States)

    Cengiz, Fatma Pelin; Emiroglu, Nazan

    2015-01-01

    BACKGROUND Mycosis fungoides, the most common subtype of cutaneous T-cell lymphoma, is more common in patients aged 45-55. OBJECTIVE Cardiovascular risk factors have been investigated in several skin diseases. However, the relation between cardiovascular diseases and mycosis fungoides remains unclear. Therefore, the aim of this study was to assess cardiovascular risk factors in patients with mycosis fungoides. METHODS 32 patients with mycosis fungoides and 26 healthy controls were enrolled in the study. Glucose, total cholesterol, high-density lipoprotein cholesterol, triglyceride, homocystein, high sensitivity C-reactive protein, low-density lipoprotein – cholesterol, were measured in the sera of patients. RESULTS Patients had significantly higher high-sensitivity C-reactive protein, homocysteine, low-density lipoprotein - cholesterol, total cholesterol (p= 0.032) (phomocysteine and high-sensitivity C-reactive protein than healthy subjects. The present study has demonstrated an increased rate of cardiovascular risk in patients with mycosis fungoides. Even though the etiology of these associations is elusive, dermatologists should be sensitized to investigate metabolic derangements in patients with mycosis fungoides, in order to lessen mortality and comorbidity with a multidisciplinary approach. PMID:25672297

  13. High-sensitivity C-reactive protein, low-density lipoprotein cholesterol and cardiovascular outcomes in patients with type 2 diabetes in the EXAMINE (Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care) trial.

    Science.gov (United States)

    Hwang, You-Cheol; Morrow, David A; Cannon, Christopher P; Liu, Yuyin; Bergenstal, Richard; Heller, Simon; Mehta, Cyrus; Cushman, William; Bakris, George L; Zannad, Faiez; White, William B

    2018-03-01

    We sought to assess the risk of major adverse cardiovascular events (MACE) by utilizing high-sensitivity C-reactive protein (hsCRP) level and low-density lipoprotein cholesterol (LDL-C) in patients with type 2 diabetes and recent acute coronary syndrome. Study participants enrolled in the EXAMINE trial (Clinical trials registration number: NCT00968708) and were stratified by baseline hsCRP levels (3 mg/L). They were also sub-divided into 4 groups according to baseline hsCRP (≤3 or >3 mg/L) and achieved LDL-C (3 mg/L, respectively (P 3 mg/L, the adjusted hazard ratio (95% confidence interval) was 1.42 (1.13, 1.78; P = .002) for MACE compared with patients with hsCRP C and low hsCRP, low LDL-C and high hsCRP, high LDL-C and low hsCRP, and high LDL-C and high hsCRP levels, respectively (P C level. © 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

  14. Myocardial perfusion in peripheral Raynaud's phenomenon. Evaluation using stress cardiovascular magnetic resonance.

    Science.gov (United States)

    Mavrogeni, Sophie; Bratis, Konstantinos; Koutsogeorgopoulou, Loukia; Karabela, Georgia; Savropoulos, Efthymios; Katsifis, Gikas; Raftakis, John; Markousis-Mavrogenis, George; Kolovou, Genovefa

    2017-02-01

    Peripheral Raynaud's phenomenon (RP) is either primary (PRP), without any coexisting disease or secondary (SRP), due to connective tissue diseases (CTD). We hypothesized that adenosine stress cardiovascular magnetic resonance (CMR) can assess myocardial perfusion in a population of PRP and SRP. Twenty CTDs, aged 30.6±7.5yrs., 16F/4M, including 9 systemic sclerosis (SSc), 4 systemic lupus erythematosus (SLE), 3 mixed connective tissue disease (MCTD), 2 polymyositis (PM) and 2 rheumatoid arthritis (RA), with SRP, under treatment with calcium blockers, were evaluated by stress CMR and compared with age-sex matched PRP and controls. All RP patients were under treatment with calcium blockers. Stress perfusion CMR was performed by 1.5T system using 140mg/kg/min adenosine for 4min and 0.05mmol/kg Gd-DTPA for first-pass perfusion. A rest perfusion was performed with the same protocol. Late gadolinium enhanced (LGE) images were acquired after another dose of Gd-DTPA. In both PRP, SRP, the myocardial perfusion reserve index (MPRI) was significantly reduced compared with the controls (1.7±0.6 vs 3.5±0.4, p<0.001 and 0.7±0.2 vs 3.5±0.4, p<0.001, respectively). Furthermore, in SRP, MPRI was significantly reduced, compared with PRP (0.7±0.2 vs 1.7±0.6, p<0.001). Subendo-cardial LGE=8.2±1.7 of LV mass was revealed in 1 SLE, 1MCTD and 2 SSc, but in none of PR patients. MPRI reduction is common in both PRP and SRP, but it is more severe in SRP, even if RP patients are under treatment with calcium blockers. Occult fibrosis may coexist with the reduced MPRI in SRP but not in PRP. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  15. Cardiovascular risk evaluation and prevalence of silent myocardial ischemia in subjects with asymptomatic carotid artery disease

    Directory of Open Access Journals (Sweden)

    Ciccone M

    2011-03-01

    Full Text Available Marco Matteo Ciccone1, Artor Niccoli-Asabella2, Pietro Scicchitano1, Michele Gesualdo1, Antonio Notaristefano2, Domenico Chieppa1, Santa Carbonara1, Gabriella Ricci1, Marco Sassara1, Corinna Altini2, Giovanni Quistelli1, Mario Erminio Lepera1, Stefano Favale1, Giuseppe Rubini21Cardiovascular Diseases Section, Department of Emergency and Organ Transplantation (DETO, 2Nuclear Medicine Unit, Department of Internal Medicine and of Public Medicine, University of Bari, Bari, ItalyIntroduction: Silent ischemia is an asymptomatic form of myocardial ischemia, not associated with angina or anginal equivalent symptoms, which can be demonstrated by changes in ECG, left ventricular function, myocardial perfusion, and metabolism. The aim of this study was to evaluate the prevalence of silent myocardial ischemia in a group of patients with asymptomatic carotid stenosis.Methods: A total of 37 patients with asymptomatic carotid plaques, without chest pain or dyspnea, was investigated. These patients were studied for age, sex, hypertension, diabetes, dyslipidemia, smoking, and family history of cardiac disease, and underwent technetium-99 m sestamibi myocardial stress-rest scintigraphy and echo-color Doppler examination of carotid arteries.Results: A statistically significant relationship (P = 0.023 was shown between positive responders and negative responders to scintigraphy test when both were tested for degree of stenosis. This relationship is surprising in view of the small number of patients in our sample. Individuals who had a positive scintigraphy test had a mean stenosis degree of 35% ± 7% compared with a mean of 44% ± 13% for those with a negative test. Specificity of our detection was 81%, with positive and negative predictive values of 60% and 63%, respectively.Conclusion: The present study confirms that carotid atherosclerosis is associated with coronary atherosclerosis and highlights the importance of screening for ischemic heart disease in

  16. Aspirin in primary prevention of cardiovascular disease and cancer: a systematic review of the balance of evidence from reviews of randomized trials.

    Directory of Open Access Journals (Sweden)

    Paul Sutcliffe

    Full Text Available Aspirin has been recommended for primary prevention of cardiovascular disease (CVD and cancer, but overall benefits are unclear. We aimed to use novel methods to re-evaluate the balance of benefits and harms of aspirin using evidence from randomised controlled trials, systematic reviews and meta-analyses.Data sources included ten electronic bibliographic databases, contact with experts, and scrutiny of reference lists of included studies. Searches were undertaken in September 2012 and restricted to publications since 2008. Of 2,572 potentially relevant papers 27 met the inclusion criteria. Meta-analysis of control arms to estimate event rates, modelling of all-cause mortality and L'Abbé plots to estimate heterogeneity were undertaken. Absolute benefits and harms were low: 60-84 major CVD events and 34-36 colorectal cancer deaths per 100,000 person-years were averted, whereas 46-49 major bleeds and 68-117 gastrointestinal bleeds were incurred. Reductions in all-cause mortality were minor and uncertain (Hazard Ratio 0.96; 95% CI: 0.90-1.02 at 20 years, Relative Risk [RR] 0.94, 95% CI: 0.88-1.00 at 8 years; there was a non-significant change in total CVD (RR 0.85, 95% CI: 0.69-1.06 and change in total cancer mortality ranged from 0.76 (95% CI: 0.66-0.88 to 0.93 (95% CI: 0.84-1.03 depending on follow-up time and studies included. Risks were increased by 37% for gastrointestinal bleeds (RR 1.37, 95% CI: 1.15-1.62, 54%-66% for major bleeds (Rate Ratio from IPD analysis 1.54, 95% CI: 1.30-1.82, and RR 1.62, 95% CI: 1.31-2.00, and 32%-38% for haemorrhagic stroke (Rate Ratio from IPD analysis 1.32; 95% CI: 1.00-1.74; RR 1.38; 95% CI: 1.01-1.82.Findings indicate small absolute effects of aspirin relative to the burden of these diseases. When aspirin is used for primary prevention of CVD the absolute harms exceed the benefits. Estimates of cancer benefit rely on selective retrospective re-analysis of RCTs and more information is needed.

  17. Effect of Loading Dose of Atorvastatin Prior to Planned Percutaneous Coronary Intervention on Major Adverse Cardiovascular Events in Acute Coronary Syndrome: The SECURE-PCI Randomized Clinical Trial.

    Science.gov (United States)

    Berwanger, Otavio; Santucci, Eliana Vieira; de Barros E Silva, Pedro Gabriel Melo; Jesuíno, Isabella de Andrade; Damiani, Lucas Petri; Barbosa, Lilian Mazza; Santos, Renato Hideo Nakagawa; Laranjeira, Ligia Nasi; Egydio, Flávia de Mattos; Borges de Oliveira, Juliana Aparecida; Dall Orto, Frederico Toledo Campo; Beraldo de Andrade, Pedro; Bienert, Igor Ribeiro de Castro; Bosso, Carlos Eduardo; Mangione, José Armando; Polanczyk, Carisi Anne; Sousa, Amanda Guerra de Moraes Rego; Kalil, Renato Abdala Karam; Santos, Luciano de Moura; Sposito, Andrei Carvalho; Rech, Rafael Luiz; Sousa, Antônio Carlos Sobral; Baldissera, Felipe; Nascimento, Bruno Ramos; Giraldez, Roberto Rocha Corrêa Veiga; Cavalcanti, Alexandre Biasi; Pereira, Sabrina Bernardez; Mattos, Luiz Alberto; Armaganijan, Luciana Vidal; Guimarães, Hélio Penna; Sousa, José Eduardo Moraes Rego; Alexander, John Hunter; Granger, Christopher Bull; Lopes, Renato Delascio

    2018-04-03

    The effects of loading doses of statins on clinical outcomes in patients with acute coronary syndrome (ACS) and planned invasive management remain uncertain. To determine if periprocedural loading doses of atorvastatin decrease 30-day major adverse cardiovascular events (MACE) in patients with ACS and planned invasive management. Multicenter, double-blind, placebo-controlled, randomized clinical trial conducted at 53 sites in Brazil among 4191 patients with ACS evaluated with coronary angiography to proceed with a percutaneous coronary intervention (PCI) if anatomically feasible. Enrollment occurred between April 18, 2012, and October 6, 2017. Final follow-up for 30-day outcomes was on November 6, 2017. Patients were randomized to receive 2 loading doses of 80 mg of atorvastatin (n = 2087) or matching placebo (n = 2104) before and 24 hours after a planned PCI. All patients received 40 mg of atorvastatin for 30 days starting 24 hours after the second dose of study medication. The primary outcome was MACE, defined as a composite of all-cause mortality, myocardial infarction, stroke, and unplanned coronary revascularization through 30 days. Among the 4191 patients (mean age, 61.8 [SD, 11.5] years; 1085 women [25.9%]) enrolled, 4163 (99.3%) completed 30-day follow-up. A total of 2710 (64.7%) underwent PCI, 333 (8%) underwent coronary artery bypass graft surgery, and 1144 (27.3%) had exclusively medical management. At 30 days, 130 patients in the atorvastatin group (6.2%) and 149 in the placebo group (7.1%) had a MACE (absolute difference, 0.85% [95% CI, -0.70% to 2.41%]; hazard ratio, 0.88; 95% CI, 0.69-1.11; P = .27). No cases of hepatic failure were reported; 3 cases of rhabdomyolysis were reported in the placebo group (0.1%) and 0 in the atorvastatin group. Among patients with ACS and planned invasive management with PCI, periprocedural loading doses of atorvastatin did not reduce the rate of MACE at 30 days. These findings do not support the routine use

  18. Effectiveness of a physical activity program on cardiovascular disease risk in adult primary health-care users: the “Pas-a-Pas” community intervention trial

    Directory of Open Access Journals (Sweden)

    Victoria Arija

    2017-06-01

    Full Text Available Abstract Background Physical activity is a major, modifiable, risk factor for cardiovascular disease (CVD that contributes to the prevention and management of CVD. The aim of this study was to assess the short- and medium-term effectiveness of 9 months of a supervised physical activity program, including sociocultural activities, on CVD risk in adults. Methods Multicentered, randomized, controlled community intervention involving 364 patients in four primary care centers. The participants were randomly assigned to a Control Group (CG = 104 or Intervention Group (IG = 260; mean age 65.19 years; 76.8% women. The intervention consisted of 120 min/week walking (396 METs/min/week and sociocultural gathering once a month. Clinical history, physical activity, dietary intake, CVD risk factors (smoking, systolic and diastolic blood pressure, weight, waist circumference, BMI, total cholesterol, LDL- and HDL-cholesterol, triglycerides, glycosylated hemoglobin and glucose and global CVD risk were assessed at baseline and at the end of the intervention and multivariate models were applied to the data. Incidence of adverse cardiovascular events and continued adherence to the physical activity were assessed 2 years after intervention. Results At the end of the intervention period, in the IG relative to the CG group, there was a significant increase in physical activity (774.81 METs/min/week, a significant change during the intervention period in systolic blood pressure (−6.63 mmHg, total cholesterol (−10.12 mg/dL and LDL-cholesterol (−9.05 mg/dL even after adjustment for potential confounders. At 2 years after the intervention, in the IG, compared with the CG, tthe incidence of adverse cardiovascular events was significantly lower (2.5% vs. 10.5% and the adherence to regular physical activity was higher (72.8% vs 27.2% in IG compared to CG. Conclusions This community-based physical activity program improved cardiovascular health in the short

  19. Changes in Cardiovascular Disease Risk Factors With Immediate Versus Deferred Antiretroviral Therapy Initiation Among HIV-Positive Participants in the START (Strategic Timing of Antiretroviral Treatment) Trial.

    Science.gov (United States)

    Baker, Jason V; Sharma, Shweta; Achhra, Amit C; Bernardino, Jose Ignacio; Bogner, Johannes R; Duprez, Daniel; Emery, Sean; Gazzard, Brian; Gordin, Jonathan; Grandits, Greg; Phillips, Andrew N; Schwarze, Siegfried; Soliman, Elsayed Z; Spector, Stephen A; Tambussi, Giuseppe; Lundgren, Jens

    2017-05-22

    HIV infection and certain antiretroviral therapy (ART) medications increase atherosclerotic cardiovascular disease risk, mediated, in part, through traditional cardiovascular disease risk factors. We studied cardiovascular disease risk factor changes in the START (Strategic Timing of Antiretroviral Treatment) trial, a randomized study of immediate versus deferred ART initiation among HIV-positive persons with CD4 + cell counts >500 cells/mm 3 . Mean change from baseline in risk factors and the incidence of comorbid conditions were compared between groups. The characteristics among 4685 HIV-positive START trial participants include a median age of 36 years, a CD4 cell count of 651 cells/mm 3 , an HIV viral load of 12 759 copies/mL, a current smoking status of 32%, a median systolic/diastolic blood pressure of 120/76 mm Hg, and median levels of total cholesterol of 168 mg/dL, low-density lipoprotein cholesterol of 102 mg/dL, and high-density lipoprotein cholesterol of 41 mg/dL. Mean follow-up was 3.0 years. The immediate and deferred ART groups spent 94% and 28% of follow-up time taking ART, respectively. Compared with patients in the deferral group, patients in the immediate ART group had increased total cholesterol and low-density lipoprotein cholesterol and higher use of lipid-lowering therapy (1.2%; 95% CI, 0.1-2.2). Concurrent increases in high-density lipoprotein cholesterol with immediate ART resulted in a 0.1 lower total cholesterol to high-density lipoprotein cholesterol ratio (95% CI, 0.1-0.2). Immediate ART resulted in 2.3% less BP-lowering therapy use (95% CI, 0.9-3.6), but there were no differences in new-onset hypertension or diabetes mellitus. Among HIV-positive persons with preserved immunity, immediate ART led to increases in total cholesterol and low-density lipoprotein cholesterol but also concurrent increases in high-density lipoprotein cholesterol and decreased use of blood pressure medications. These opposing effects suggest that, in

  20. Effect of dietary pulse intake on established therapeutic lipid targets for cardiovascular risk reduction: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Ha, Vanessa; Sievenpiper, John L; de Souza, Russell J; Jayalath, Viranda H; Mirrahimi, Arash; Agarwal, Arnav; Chiavaroli, Laura; Mejia, Sonia Blanco; Sacks, Frank M; Di Buono, Marco; Bernstein, Adam M; Leiter, Lawrence A; Kris-Etherton, Penny M; Vuksan, Vladimir; Bazinet, Richard P; Josse, Robert G; Beyene, Joseph; Kendall, Cyril W C; Jenkins, David J A

    2014-05-13

    Evidence from controlled trials encourages the intake of dietary pulses (beans, chickpeas, lentils and peas) as a method of improving dyslipidemia, but heart health guidelines have stopped short of ascribing specific benefits to this type of intervention or have graded the beneficial evidence as low. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to assess the effect of dietary pulse intake on established therapeutic lipid targets for cardiovascular risk reduction. We searched electronic databases and bibliographies of selected trials for relevant articles published through Feb. 5, 2014. We included RCTs of at least 3 weeks' duration that compared a diet emphasizing dietary pulse intake with an isocaloric diet that did not include dietary pulses. The lipid targets investigated were low-density lipoprotein (LDL) cholesterol, apolipoprotein B and non-high-density lipoprotein (non-HDL) cholesterol. We pooled data using a random-effects model. We identified 26 RCTs (n = 1037) that satisfied the inclusion criteria. Diets emphasizing dietary pulse intake at a median dose of 130 g/d (about 1 serving daily) significantly lowered LDL cholesterol levels compared with the control diets (mean difference -0.17 mmol/L, 95% confidence interval -0.25 to -0.09 mmol/L). Treatment effects on apolipoprotein B and non-HDL cholesterol were not observed. Our findings suggest that dietary pulse intake significantly reduces LDL cholesterol levels. Trials of longer duration and higher quality are needed to verify these results. ClinicalTrials.gov, no. NCT01594567.

  1. Impact of a nurse-led intervention to improve screening for cardiovascular risk factors in people with severe mental illnesses. Phase-two cluster randomised feasibility trial of community mental health teams

    Directory of Open Access Journals (Sweden)

    Nazareth Irwin

    2010-03-01

    Full Text Available Abstract Background People with severe mental illnesses (SMI are at increased risk of cardiovascular disease (CVD. Clinical guidelines recommend regular screening for CVD risk factors. We evaluated a nurse led intervention to improve screening rates across the primary-secondary care interface. Methods Six community mental health teams (CMHTs were randomised to receive either the nurse led intervention plus education pack (n = 3 or education pack only (n = 3. Intervention (6 months: The nurse promoted CVD screening in primary care and then in CMHTs. Patients who remained unscreened were offered screening by the nurse. After the intervention participants with SMI were recruited from each CMHT to collect outcome data. Main outcome: Numbers screened during the six months, confirmed in General Practice notes. Results All six CMHTs approached agreed to randomisation. 121 people with SMI participated in outcome interviews during two waves of recruitment (intervention arm n = 59, control arm n = 62. Participants from both arms of the trial had similar demographic profiles and rates of previous CVD screening in the previous year, with less than 20% having been screened for each risk factor. After the trial, CVD screening had increased in both arms but participants from the intervention arm were significantly more likely to have received screening for blood pressure (96% vs 68%; adjusted Odds Ratio (OR 13.6; 95% CI: 3.5-38.4, cholesterol (66.7% vs 26.9%, OR 6.1; 3.2-11.5, glucose (66.7% vs 36.5% OR 4.4; 2.7-7.1, BMI (92.5% vs 65.2% OR 6.5; 2.1-19.6, and smoking status (88.2% vs 57.8% OR 5.5; 3.2-9.5 and have a 10 year CVD risk score calculated (38.2% vs 10.9% OR 5.2 1.8-15.3. Within the intervention arm approximately half the screening was performed in general practice and half by the trial nurse. Conclusions The nurse-led intervention was superior, resulting in an absolute increase of approximately 30% more people with SMI receiving screening for each

  2. Diabetes Drugs and Cardiovascular Safety

    Directory of Open Access Journals (Sweden)

    Ji Cheol Bae

    2016-06-01

    Full Text Available Diabetes is a well-known risk factor of cardiovascular morbidity and mortality, and the beneficial effect of improved glycemic control on cardiovascular complications has been well established. However, the rosiglitazone experience aroused awareness of potential cardiovascular risk associated with diabetes drugs and prompted the U.S. Food and Drug Administration to issue new guidelines about cardiovascular risk. Through postmarketing cardiovascular safety trials, some drugs demonstrated cardiovascular benefits, while some antidiabetic drugs raised concern about a possible increased cardiovascular risk associated with drug use. With the development of new classes of drugs, treatment options became wider and the complexity of glycemic management in type 2 diabetes has increased. When choosing the appropriate treatment strategy for patients with type 2 diabetes at high cardiovascular risk, not only the glucose-lowering effects, but also overall benefits and risks for cardiovascular disease should be taken into consideration.

  3. Evaluation of red blood cell (RBC) labelling procedures in cardiovascular scintigraphy

    International Nuclear Information System (INIS)

    Hinkle, G.H.; Reid, R.D.; Shaffer, P.B.; Olsen, J.O.

    1984-01-01

    The clinical images obtained and the percentage of radioactivity associated with the red blood cells at the conclusion of this study provided a method of assessing four technique for preparing 99 mTc-labeled red blood cells for use in cardiovascular scintigraphy. The methods consisted of a totally in vivo preparation, and semi-in vitro and two different cell separation techniques. The semi-in vitro procedure provided the best clinical image with the highest ventricle to spleen and ventricle to lung ratios. Higher count rates in the left ventricle also led to shorter acquisition times and greater efficiency of ejection fraction calculations. A semi-in vitro method of labelling red-blood cells improves the nuclear medicine cardiovascular studies utilized for cardiac function determination

  4. A community-based intervention for primary prevention of cardiovascular diseases in the slums of Nairobi: the SCALE UP study protocol for a prospective quasi-experimental community-based trial

    NARCIS (Netherlands)

    Oti, Samuel O.; van de Vijver, Steven J. M.; Kyobutungi, Catherine; Gomez, Gabriela B.; Agyemang, Charles; Moll van Charante, Eric P.; Brewster, Lizzy M.; Hendriks, Marleen E.; Schultsz, Constance; Ettarh, Remare; Ezeh, Alex; Lange, Joep

    2013-01-01

    The burden of cardiovascular disease is rising in sub-Saharan Africa with hypertension being the main risk factor. However, context-specific evidence on effective interventions for primary prevention of cardiovascular diseases in resource-poor settings is limited. This study aims to evaluate the

  5. Toxicity classification and evaluation of four pharmaceuticals classes: antibiotics, antineoplastics, cardiovascular, and sex hormones

    International Nuclear Information System (INIS)

    Sanderson, Hans; Brain, Richard A.; Johnson, David J.; Wilson, Christian J.; Solomon, Keith R.

    2004-01-01

    Four different classes of environmental concern are quantitatively and qualitatively assessed for environmental hazards; antibiotics (n = 226), antineoplastics (n = 81), cardiovascular (n = 272), and sex hormones (n 92). These along with an ECOSAR scan of all pharmaceuticals (n = 2848) were then classified according to the OECD aquatic toxicity classification system. The predicted species susceptibility is: daphnid > fish > algae, and the predicted rank order of relative toxicity: sex hormones > cardiovascular antibiotics > antineoplastics (Table 1). Generally, a relatively large proportion (1/3) of all pharmaceuticals are potentially very toxic to aquatic organisms (Table 2). The qualitative risk assessment ranking relative to probability and potential severity for human and environmental health effects is: antibiotics > sex hormones > cardiovascular > antineoplastics. (Q)SARs and pharmacodynamic information should be used to prioritize and steer experimental risk assessments of pharmaceuticals, and potentially, also be used in new drug discovery optimizing efficacy and in minimising environmental hazards of new products. Nuclear receptors are relatively well conserved in evolution. Currently, antibacterial resistance represents the most significant human health hazard, and potentially the largest non-target organism hazard is sex hormones acting as endocrine modulators in wildlife. Data for the individual compounds are accessible via http://www.uoguelph.ca/~hsander/

  6. Evaluation of the cardiovascular system by digital subtraction angiography in 246 patients

    Energy Technology Data Exchange (ETDEWEB)

    Higuma, Kikuhiko; Ohta, Takashi; Hiroto, Seiji

    1987-07-01

    Usefulness of intravenous digital subtraction angiography (DSA) was examined in 246 patients with cardiovascular disorders. This examination was done by centrally intravenous DSA (CIVDSA) in all patients to reduce the risks and discomforts by peripheral intravenous DSA. 1) CIVDSA could be done safely in patients aged 18 to 81 years. 2) The good diagnostic quality by CIVDSA was obtained in 81.3% of patients. These images were classified into 7 groups according to the cardiovascular system, that is, the jugular arteries, the upper extremity arteries, the thoracic aorta, the left ventricle, the abnominal aorta, the renal arteries, and the lower extremity arteries, whose rate of good diagnostic quality were 100%, 70%, 67.7%, 79.5%, 84.8%, 87%, and 71.4% respectively. 3) The poor diagnostic quality was obtained in 18.7%. 4) The severe complications were not found in any case during this examination. Our results indicate that DSA is the safe, simple and useful method to obtain the diagnostic quality image of the cardiovascular system, especially, of the occulsive arterial disease, the aortic aneurisma, the renovascular stenosis and the cardiac function of postmyocardial infarction, even in aged patients.

  7. Evaluation of the cardiovascular system by digital subtraction angiography in 246 patients

    International Nuclear Information System (INIS)

    Higuma, Kikuhiko; Ohta, Takashi; Hiroto, Seiji

    1987-01-01

    Usefulness of intravenous digital subtraction angiography (DSA) was examined in 246 patients with cardiovascular disorders. This examination was done by centrally intravenous DSA (CIVDSA) in all patients to reduce the risks and discomforts by peripheral intravenous DSA. 1) CIVDSA could be done safely in patients aged 18 to 81 years. 2) The good diagnostic quality by CIVDSA was obtained in 81.3 % of patients. These images were classified into 7 groups according to the cardiovascular system, that is, the jugular arteries, the upper extremity arteries, the thoracic aorta, the left ventricle, the abnominal aorta, the renal arteries, and the lower extremity arteries, whose rate of good diagnostic quality were 100 %, 70 %, 67.7 %, 79.5 %, 84.8 %, 87 %, and 71.4 % respectively. 3) The poor diagnostic quality was obtained in 18.7 %. 4) The severe complications were not found in any case during this examination. Our results indicate that DSA is the safe, simple and useful method to obtain the diagnostic quality image of the cardiovascular system, especially, of the occulsive arterial disease, the aortic aneurisma, the renovascular stenosis and the cardiac function of postmyocardial infarction, even in aged patients. (author)

  8. Effect of population screening for type 2 diabetes and cardiovascular risk factors on mortality rate and cardiovascular events

    DEFF Research Database (Denmark)

    Simmons, Rebecca K; Griffin, Simon J; Witte, Daniel R

    2017-01-01

    and cardiovascular events (cardiovascular disease death, non-fatal ischaemic heart disease or stroke). The analysis was performed according to the intention-to-screen principle. RESULTS: Among the screening group, 27,177 (18%) individuals attended for assessment of diabetes status and cardiovascular risk. Of these......AIMS/HYPOTHESIS: Health check programmes for chronic disease have been introduced in a number of countries. However, there are few trials assessing the benefits and harms of these screening programmes at the population level. In a post hoc analysis, we evaluated the effect of population...

  9. Tomato Sauce Enriched with Olive Oil Exerts Greater Effects on Cardiovascular Disease Risk Factors than Raw Tomato and Tomato Sauce: A Randomized Trial

    Directory of Open Access Journals (Sweden)

    Palmira Valderas-Martinez

    2016-03-01

    Full Text Available Epidemiological studies have observed a negative association between tomato intake and the incidence of cardiovascular disease. As tomato sauces are usually cooked with the addition of oil, some studies have pointed out that both processes may increase the bioavailability of the bioactive compounds. However, the effect of consumption of raw tomatoes and tomato sauces on inflammation biomarkers and adhesion molecules related to atherosclerosis remains unknown. The aim of this study was to test the postprandial effects of a single dose of raw tomatoes (RT, tomato sauce (TS and tomato sauce with refined olive oil (TSOO on cardiovascular disease risk factors. We performed an open, prospective, randomized, cross-over, controlled feeding trial in 40 healthy subjects who randomly received: 7.0 g of RT/kg of body weight (BW, 3.5 g of TS/kg BW, 3.5 g of TSOO/Kg BW and 0.25 g of sugar solved in water/kg BW on a single occasion on four different days. Biochemical parameters and cellular and circulating inflammatory biomarkers were assessed at baseline and 6 h after each intervention. The results indicate that, compared to control intervention, a single tomato intake in any form decreased plasma total cholesterol, triglycerides and several cellular and plasma inflammatory biomarkers, and increased plasma high density lipoproteins (HDL cholesterol and interleukine (IL 10 concentrations. However, the changes of plasma IL-6 and vascular cell adhesion molecule-1 (VCAM-1, and lymphocyte function-associated antigen-1 (LFA-1 from T-lymphocytes and CD36 from monocytes were significantly greater after TSOO than after RT and TS interventions. We concluded that tomato intake has beneficial effects on cardiovascular risk factors, especially cooked and enriched with oil.

  10. Tomato Sauce Enriched with Olive Oil Exerts Greater Effects on Cardiovascular Disease Risk Factors than Raw Tomato and Tomato Sauce: A Randomized Trial.

    Science.gov (United States)

    Valderas-Martinez, Palmira; Chiva-Blanch, Gemma; Casas, Rosa; Arranz, Sara; Martínez-Huélamo, Miriam; Urpi-Sarda, Mireia; Torrado, Xavier; Corella, Dolores; Lamuela-Raventós, Rosa M; Estruch, Ramon

    2016-03-16

    Epidemiological studies have observed a negative association between tomato intake and the incidence of cardiovascular disease. As tomato sauces are usually cooked with the addition of oil, some studies have pointed out that both processes may increase the bioavailability of the bioactive compounds. However, the effect of consumption of raw tomatoes and tomato sauces on inflammation biomarkers and adhesion molecules related to atherosclerosis remains unknown. The aim of this study was to test the postprandial effects of a single dose of raw tomatoes (RT), tomato sauce (TS) and tomato sauce with refined olive oil (TSOO) on cardiovascular disease risk factors. We performed an open, prospective, randomized, cross-over, controlled feeding trial in 40 healthy subjects who randomly received: 7.0 g of RT/kg of body weight (BW), 3.5 g of TS/kg BW, 3.5 g of TSOO/Kg BW and 0.25 g of sugar solved in water/kg BW on a single occasion on four different days. Biochemical parameters and cellular and circulating inflammatory biomarkers were assessed at baseline and 6 h after each intervention. The results indicate that, compared to control intervention, a single tomato intake in any form decreased plasma total cholesterol, triglycerides and several cellular and plasma inflammatory biomarkers, and increased plasma high density lipoproteins (HDL) cholesterol and interleukine (IL) 10 concentrations. However, the changes of plasma IL-6 and vascular cell adhesion molecule-1 (VCAM-1), and lymphocyte function-associated antigen-1 (LFA-1) from T-lymphocytes and CD36 from monocytes were significantly greater after TSOO than after RT and TS interventions. We concluded that tomato intake has beneficial effects on cardiovascular risk factors, especially cooked and enriched with oil.

  11. Tomato Sauce Enriched with Olive Oil Exerts Greater Effects on Cardiovascular Disease Risk Factors than Raw Tomato and Tomato Sauce: A Randomized Trial

    Science.gov (United States)

    Valderas-Martinez, Palmira; Chiva-Blanch, Gemma; Casas, Rosa; Arranz, Sara; Martínez-Huélamo, Miriam; Urpi-Sarda, Mireia; Torrado, Xavier; Corella, Dolores; Lamuela-Raventós, Rosa M.; Estruch, Ramon

    2016-01-01

    Epidemiological studies have observed a negative association between tomato intake and the incidence of cardiovascular disease. As tomato sauces are usually cooked with the addition of oil, some studies have pointed out that both processes may increase the bioavailability of the bioactive compounds. However, the effect of consumption of raw tomatoes and tomato sauces on inflammation biomarkers and adhesion molecules related to atherosclerosis remains unknown. The aim of this study was to test the postprandial effects of a single dose of raw tomatoes (RT), tomato sauce (TS) and tomato sauce with refined olive oil (TSOO) on cardiovascular disease risk factors. We performed an open, prospective, randomized, cross-over, controlled feeding trial in 40 healthy subjects who randomly received: 7.0 g of RT/kg of body weight (BW), 3.5 g of TS/kg BW, 3.5 g of TSOO/Kg BW and 0.25 g of sugar solved in water/kg BW on a single occasion on four different days. Biochemical parameters and cellular and circulating inflammatory biomarkers were assessed at baseline and 6 h after each intervention. The results indicate that, compared to control intervention, a single tomato intake in any form decreased plasma total cholesterol, triglycerides and several cellular and plasma inflammatory biomarkers, and increased plasma high density lipoproteins (HDL) cholesterol and interleukine (IL) 10 concentrations. However, the changes of plasma IL-6 and vascular cell adhesion molecule-1 (VCAM-1), and lymphocyte function-associated antigen-1 (LFA-1) from T-lymphocytes and CD36 from monocytes were significantly greater after TSOO than after RT and TS interventions. We concluded that tomato intake has beneficial effects on cardiovascular risk factors, especially cooked and enriched with oil. PMID:26999197

  12. Characteristics Associated With Decreased or Increased Mortality Risk From Glycemic Therapy Among Patients With Type 2 Diabetes and High Cardiovascular Risk: Machine Learning Analysis of the ACCORD Trial.

    Science.gov (United States)

    Basu, Sanjay; Raghavan, Sridharan; Wexler, Deborah J; Berkowitz, Seth A

    2018-03-01

    Identifying patients who may experience decreased or increased mortality risk from intensive glycemic therapy for type 2 diabetes remains an important clinical challenge. We sought to identify characteristics of patients at high cardiovascular risk with decreased or increased mortality risk from glycemic therapy for type 2 diabetes using new methods to identify complex combinations of treatment effect modifiers. The machine learning method of gradient forest analysis was applied to understand the variation in all-cause mortality within the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial ( N = 10,251), whose participants were 40-79 years old with type 2 diabetes, hemoglobin A 1c (HbA 1c ) ≥7.5% (58 mmol/mol), cardiovascular disease (CVD) or multiple CVD risk factors, and randomized to target HbA 1c intensive) or 7.0-7.9% (53-63 mmol/mol; standard). Covariates included demographics, BMI, hemoglobin glycosylation index (HGI; observed minus expected HbA 1c derived from prerandomization fasting plasma glucose), other biomarkers, history, and medications. The analysis identified four groups defined by age, BMI, and HGI with varied risk for mortality under intensive glycemic therapy. The lowest risk group (HGI intensive therapy (95% CI 0.2 to 4.5, P = 0.038; number needed to treat: 43), whereas the highest risk group (HGI ≥0.44) had an absolute mortality risk increase of 3.7% attributable to intensive therapy (95% CI 1.5 to 6.0; P intensive glycemic therapy. © 2017 by the American Diabetes Association.

  13. Effects of Calcium, Vitamin D, and Hormone Therapy on Cardiovascular Disease Risk Factors in the Women's Health Initiative: A Randomized Controlled Trial.

    Science.gov (United States)

    Schnatz, Peter F; Jiang, Xuezhi; Aragaki, Aaron K; Nudy, Matthew; OʼSullivan, David M; Williams, Mark; LeBlanc, Erin S; Martin, Lisa W; Manson, JoAnn E; Shikany, James M; Johnson, Karen C; Stefanick, Marcia L; Payne, Martha E; Cauley, Jane A; Howard, Barbara V; Robbins, John

    2017-01-01

    To analyze the treatment effect of calcium+vitamin D supplementation, hormone therapy, both, and neither on cardiovascular disease risk factors. We conducted a prospective, randomized, double-blind, placebo-controlled trial among Women's Health Initiative (WHI) participants. The predefined primary outcome was low-density lipoprotein cholesterol (LDL-C). Between September 1993 and October 1998, a total of 68,132 women aged 50-79 years were recruited and randomized to the WHI-Dietary Modification (n=48,835) and WHI-Hormone Therapy trials (n=27,347). Subsequently, 36,282 women from WHI-Hormone Therapy (16,089) and WHI-Dietary Modification (n=25,210) trials were randomized in the WHI-Calcium+Vitamin D trial to 1,000 mg elemental calcium carbonate plus 400 international units vitamin D3 daily or placebo. Our study group included 1,521 women who participated in both the hormone therapy and calcium+vitamin D trials and were in the 6% subsample of trial participants with blood sample collections at baseline and years 1, 3, and 6. The average treatment effect with 95% confidence interval, for LDL-C, compared with placebo, was -1.6, (95% confidence interval [CI] -5.5 to 2.2) mg/dL for calcium+vitamin D alone, -9.0 (95% CI -13.0 to -5.1) mg/dL for hormone therapy alone, and -13.8 (95% CI -17.8 to -9.8) mg/dL for the combination. There was no evidence of a synergistic effect of calcium+vitamin D+hormone therapy on LDL-C (P value for interaction=.26) except in those with low total intakes of vitamin D, for whom there was a significant synergistic effect on LDL (P value for interaction=.03). Reductions in LDL-C were greater among women randomized to both calcium+vitamin D and hormone therapy than for those randomized to either intervention alone or to placebo. The treatment effect observed in the calcium+vitamin D+hormone therapy combination group may be additive rather than synergistic. For clinicians and patients deciding to begin calcium+vitamin D supplementation, current use

  14. Evaluation of three cardiovascular nuclear medicine procedures for the study of ischemic heart disease in the aged

    International Nuclear Information System (INIS)

    Iio, M.; Nakai, K.; Murata, H.

    1979-01-01

    Three recent developments of cardiovascular nuclear medicine procedures were evaluated for the study of ischemic heart diseases in the aged. Regional analysis and global analysis was possible by the gated pool method and Tl-201 scanning. The temporal imaging method, even though limited to global function, was proven to be suitable for the dynamic analysis of the ejection fraction at rest and at stress. Therefore combination of these three procedures made it possible to analyse both regional and global functions of the left ventricle of the patient with IHD without any load on the patient and even under physiological conditions. (Auth.)

  15. Randomized trial of one-hour sodium bicarbonate vs standard periprocedural saline hydration in chronic kidney disease patients undergoing cardiovascular contrast procedures.

    Science.gov (United States)

    Kooiman, Judith; de Vries, Jean-Paul P M; Van der Heyden, Jan; Sijpkens, Yvo W J; van Dijkman, Paul R M; Wever, Jan J; van Overhagen, Hans; Vahl, Antonie C; Aarts, Nico; Verberk-Jonkers, Iris J A M; Brulez, Harald F H; Hamming, Jaap F; van der Molen, Aart J; Cannegieter, Suzanne C; Putter, Hein; van den Hout, Wilbert B; Kilicsoy, Inci; Rabelink, Ton J; Huisman, Menno V

    2018-01-01

    Guidelines advise periprocedural saline hydration for prevention of contrast induced-acute kidney injury (CI-AKI). We analysed whether 1-hour sodium bicarbonate hydration administered solely prior to intra-arterial contrast exposure is non-inferior to standard periprocedural saline hydration in chronic kidney disease (CKD) patients undergoing elective cardiovascular diagnostic or interventional contrast procedures. We performed an open-label multicentre non-inferiority trial between 2011-2014. Patients were randomized to 1 hour pre-procedure sodium bicarbonate hydration (250 ml 1.4%, N = 168) or 4-12 hours saline hydration (1000 ml 0.9%, N = 165) prior to and following contrast administration (2000 ml of saline total). Primary outcome was the relative serum creatinine increase (%) 48-96 hours post contrast exposure. Secondary outcomes were: incidence of CI-AKI (serum creatinine increase>25% or >44μmol/L), recovery of renal function, the need for dialysis, and hospital costs within two months follow-up. Mean relative creatinine increase was 3.1% (95%CI 0.9 to 5.2%) in the bicarbonate and 1.1% (95%CI -1.2 to 3.5%) in the saline arm, mean difference 1.9% (95%CI -1.2 to 5.1%, p-non-inferiority sodium bicarbonate and 12 (7.5%) to saline (p = 0.79). Renal function did not fully recover in 40.0% and 44.4% of CI-AKI patients, respectively (p = 0.84). No patient required dialysis. Mean costs for preventive hydration and clinical preparation for the contrast procedure were $1158 for sodium bicarbonate vs. $1561 for saline (p sodium bicarbonate prior to elective cardiovascular diagnostic or therapeutic contrast procedures is non-inferior to standard periprocedural saline hydration in CKD patients with respect to renal safety and results in considerable healthcare savings. Netherlands Trial Register (http://www.trialregister.nl/trialreg/index.asp), Nr NTR2699.

  16. Kā-HOLO Project: a protocol for a randomized controlled trial of a native cultural dance program for cardiovascular disease prevention in Native Hawaiians

    Directory of Open Access Journals (Sweden)

    Joseph Keawe‘aimoku Kaholokula

    2017-04-01

    Full Text Available Abstract Background As a major risk factor for cardiovascular and cerebrovascular disease (CVD, hypertension affects 33% of U.S. adults. Relative to other US races and ethnicities, Native Hawaiians have a high prevalence of hypertension and are 3 to 4 times more likely to have CVD. Effective, culturally-relevant interventions are needed to address CVD risk in this population. Investigators of the Kā-HOLO Project developed a study design to test the efficacy of an intervention that uses hula, a traditional Hawaiian dance, to increase physical activity and reduce CVD risk. Methods A 2-arm randomized controlled trial with a wait-list control design will be implemented to test a 6-month intervention based on hula to manage blood pressure and reduce CVD risk in 250 adult Native Hawaiians with diagnosed hypertension. Half of the sample will be randomized to each arm, stratified across multiple study sites. Primary outcomes are reduction in systolic blood pressure and improvement in CVD risk as measured by the Framingham Risk Score. Other psychosocial and sociocultural measures will be included to determine mediators of intervention effects on primary outcomes. Assessments will be conducted at baseline, 3 months, and 6 months for all participants, and at 12 months for intervention participants only. Discussion This trial will elucidate the efficacy of a novel hypertension management program designed to reduce CVD risk in an indigenous population by using a cultural dance form as its physical activity component. The results of this culturally-based intervention will have implications for other indigenous populations globally and will offer a sustainable, culturally-relevant means of addressing CVD disparities. Trial registration ClinicalTrials.gov: NCT02620709 , registration date November 23, 2015.

  17. Evaluation of radiolabelled annexin A5 for scintigraphic imaging of cell processes (necrosis/apoptosis) in cardiovascular diseases

    International Nuclear Information System (INIS)

    Sarda-Mantel, L.

    2007-03-01

    Annexin A5, a 35KDa protein, specifically binds with high affinity to phosphatidylserine (P.S.) which is actively redistributed to the external leaflet of plasmic membranes in apoptotic cells and activated platelets. Annexin A5 radiolabelled with 99m Tc( 99m Tc-ANX5) was developed by Strauss (stanford, Usa) to image apoptosis in vivo: tumours cells apoptosis induced by chemo-radiotherapy, ischemia/reperfusion lesions in animals and patients, graft rejection. Additionally, many in vitro data suggest that annexin A5 also stains necrosis (membrane disruption), which occurs in all types of cell death. This preclinical work aimed to evaluate the potential interest of 99m Tc-ANX5 imaging as a clinical tool in cardiovascular diseases. Four studies performed in rat models of myocardial infarction by coronary ligation and ischemia-reperfusion, and in rat models of subacute and acute (isoproterenol-induced) myocarditis show the ability of 99m Tc-ANX5 to detect in vivo cardio myocytes death by apoptosis and necrosis. Another study demonstrates that 99m Tc-ANX5 is highly accurate to evaluate in vivo the biological activity of parietal thrombus in a rat model of elastase-induced abdominal aortic aneurysm. These results suggest that 99m Tc-ANX5 imaging could be used in patients for non invasive diagnosis, prognostic evaluation in acute myocarditis and in various thrombotic cardiovascular diseases. (author)

  18. Multimodality imaging evaluation of Chagas disease: an expert consensus of Brazilian Cardiovascular Imaging Department (DIC) and the European Association of Cardiovascular Imaging (EACVI).

    Science.gov (United States)

    Nunes, Maria Carmo P; Badano, Luigi Paolo; Marin-Neto, J Antonio; Edvardsen, Thor; Fernández-Golfín, Covadonga; Bucciarelli-Ducci, Chiara; Popescu, Bogdan A; Underwood, Richard; Habib, Gilbert; Zamorano, Jose Luis; Saraiva, Roberto Magalhães; Sabino, Ester Cerdeira; Botoni, Fernando A; Barbosa, Márcia Melo; Barros, Marcio Vinicius L; Falqueto, Eduardo; Simões, Marcus Vinicius; Schmidt, André; Rochitte, Carlos Eduardo; Rocha, Manoel Otávio Costa; Ribeiro, Antonio Luiz Pinho; Lancellotti, Patrizio

    2018-04-01

    To develop a document by Brazilian Cardiovascular Imaging Department (DIC) and the European Association of Cardiovascular Imaging (EACVI) to review and summarize the most recent evidences about the non-invasive assessment of patients with Chagas disease, with the intent to set up a framework for standardized cardiovascular imaging to assess cardiovascular morphologic and functional disturbances, as well as to guide the subsequent process of clinical decision-making. Chagas disease remains one of the most prevalent infectious diseases in Latin America, and has become a health problem in non-endemic countries. Dilated cardiomyopathy is the most severe manifestation of Chagas disease, which causes substantial disability and early mortality in the socially most productive population leading to a significant economical burden. Prompt and correct diagnosis of Chagas disease requires specialized clinical expertise to recognize the unique features of this disease. The appropriate and efficient use of cardiac imaging is pivotal for diagnosing the cardiac involvement in Chagas disease, to stage the disease, assess patients' prognosis and address management. Echocardiography is the most common imaging modality used to assess, and follow-up patients with Chagas disease. The presence of echocardiographic abnormalities is of utmost importance, since it allows to stage patients according to disease progression. In early stages of cardiac involvement, echocardiography may demonstrate segmental left ventricuar wall motion abnormalities, mainly in the basal segments of inferior, inferolateral walls, and the apex, which cannot be attributed to obstructive coronary artery arteries. The prevalence of segmental wall motion abnormalities varies according to the stage of the disease, reaching about 50% in patients with left ventricular dilatation and dysfunction. Speckle tracking echocardiography allows a more precise and quantitative measurement of the regional myocardial function. Since

  19. Growth hormone treatment during hemodialysis in a randomized trial improves nutrition, quality of life, and cardiovascular risk

    DEFF Research Database (Denmark)

    Feldt-Rasmussen, Bo; Lange, Martin; Sulowicz, Wladyslaw

    2007-01-01

    Nutritional markers, such as lean body mass (LBM) and serum albumin, predict outcome in dialysis patients, in whom protein-energy malnutrition is associated with increased morbidity and mortality. The metabolic effects of human growth hormone (hGH) may improve the nutritional and cardiovascular...... health of these patients and consequently reduce morbidity and mortality. The aim of this study was to establish clinical proof of concept of hGH treatment for the improvement of the nutritional status in adult patients who are on maintenance hemodialysis. A total of 139 adult patients who were...

  20. The effects of resveratrol intervention on risk markers of cardiovascular health in overweight and obese subjects: a pooled analysis of randomized controlled trials.

    Science.gov (United States)

    Huang, Haohai; Chen, Guangzhao; Liao, Dan; Zhu, Yongkun; Pu, Rong; Xue, Xiaoyan

    2016-12-01

    Potential effects of resveratrol consumption on cardiovascular disease risk factors and body weight in overweight/obese adults have not been fully elucidated. Our present analysis was to evaluate the effects of resveratrol consumption on risk markers related to cardiovascular health in overweight/obese Individuals. Multiple literature databases were systematically searched, and 21 studies were included. Effect sizes were expressed as weighted mean difference (WMD) and 95% confidence interval (CI), and heterogeneity was assessed with the I2 test. Publication bias and subgroup analyses were also performed. There were variations in reporting quality of included studies. Resveratrol intervention significantly lowered total cholesterol (WMD, -0.19 mmol/L; 95% CI, -0.32 to -0.06; P = 0.004), systolic blood pressure (WMD, -2.26 mmHg; 95% CI, -4.82 to -0.49; P = 0.02), and fasting glucose (WMD, -0.22 mmol/L; 95% CI, -0.42 to -0.03; P = 0.03). Heterogeneity was noted for these outcomes (35.6%, 38.7% and 71.4%, respectively). Our subgroup analysis showed significant reductions in total cholesterol, systolic blood pressure, diastolic blood pressure, glucose, and insulin in subjects ingesting higher dose of resveratrol (≥300 mg/day). Our finding provides evidence that daily resveratrol consumption might be a candidate as an adjunct to pharmacological management to better prevent and control cardiovascular disease in overweight/obese individuals. © 2016 World Obesity Federation.

  1. Importance of a history of hypertension for the prognosis after acute myocardial infarction--for the Bucindolol Evaluation in Acute myocardial infarction Trial (BEAT) study group

    DEFF Research Database (Denmark)

    Ali, Irma; Akman, Dilek; Bruun, Niels Eske

    2004-01-01

    BACKGROUND: Arterial hypertension is a major risk factor for cardiovascular events. The prognosis for hypertensive patients after acute myocardial infarction (MI) is uncertain because of the sparse and somewhat contradictionary data. HYPOTHESIS: Our study aimed to investigate the importance...... of hypertension to prognosis after an MI in patients receiving contemporary medical therapy. METHODS: We performed a retrospective study using a large register from the Bucindolol Evaluation in Acute myocardial infarction Trial (BEAT). The register comprised 3,326 patients admitted between June 1998 and August...

  2. The effects of the mediterranean diet on biomarkers of vascular wall inflammation and plaque vulnerability in subjects with high risk for cardiovascular disease. A randomized trial.

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    Rosa Casas

    Full Text Available BACKGROUND: Adherence to the Mediterranean diet (MD is associated with reduced morbidity and mortality due to cardiovascular disease. However, how the MD exerts its effects is not fully known. AIM: To assess the 12-month effects of two enhanced MDs compared to a low-fat diet on inflammatory biomarkers related to atherosclerosis and plaque vulnerability in a subcohort of the PREDIMED (Prevención con Dieta Mediterránea study. METHODS: A total of 164 participants at high risk for cardiovascular disease were randomized into three diet groups: MD supplemented with 50mL/d of extra virgin olive oil (MD+EVOO or 30 g/d of nuts (MD+Nuts and a low-fat diet. Changes in classical cardiovascular risk factors, inflammatory biomarkers of atherosclerosis and plaque vulnerability were measured after 12 months of intervention. RESULTS: Compared to participants in the low-fat diet group, those receiving MD+EVOO and MD+Nuts showed a higher decrease in systolic (6mmHg and diastolic (3mmHg blood pressure (P = 0.02; both, as well as a reduction of 10% and 8% in LDL-cholesterol (P = 0.04, respectively. Patients in the MD+Nuts group showed a significant reduction of 34% in CD40 expression on monocyte surface compared to low-fat diet patients (P = 0.03. In addition, inflammatory biomarkers related to plaque instability such as C-reactive protein and interleukin-6 were reduced by 45% and 35% and 95% and 90% in the MD+EVOO and MD+Nuts groups, respectively (P<0.05; all compared to the low-fat diet group. Likewise, sICAM and P-selectin were also reduced by 50% and 27%, respectively in the MD+EVOO group (P = 0.04 and P-selectin by 19% in MD+Nuts group (P = 0.04 compared to the low-fat diet group. CONCLUSIONS: Adherence to the MD is associated with an increase in serum markers of atheroma plaque stability which may explain, at least in part, the protective role of MD against ischemic heart disease. TRIAL REGISTRATION: www.controlled-trials.com ISRCTN

  3. Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease

    NARCIS (Netherlands)

    Eikelboom, John W.; Connolly, Stuart J.; Bosch, Jackie; Dagenais, Gilles R.; Hart, Robert G.; Shestakovska, Olga; Diaz, Rafael; Alings, Marco; Lonn, Eva M.; Anand, Sonia S.; Widimsky, Petr; Hori, Masatsugu; Avezum, Alvaro; Piegas, Leopoldo S.; Branch, Kelley R. H.; Probstfield, Jeffrey; Bhatt, Deepak L.; Zhu, Jun; Liang, Yan; Maggioni, Aldo P.; Lopez-Jaramillo, Patricio; O'Donnell, Martin; Kakkar, Ajay K.; Fox, Keith A. A.; Parkhomenko, Alexander N.; Ertl, Georg; Störk, Stefan; Keltai, Matyas; Ryden, Lars; Pogosova, Nana; Dans, Antonio L.; Lanas, Fernando; Commerford, Patrick J.; Torp-Pedersen, Christian; Guzik, Tomek J.; Verhamme, Peter B.; Vinereanu, Dragos; Kim, Jae-Hyung; Tonkin, Andrew M.; Lewis, Basil S.; Felix, Camilo; Yusoff, Khalid; Steg, P. Gabriel; Metsarinne, Kaj P.; Cook Bruns, Nancy; Misselwitz, Frank; Chen, Edmond; Leong, Darryl; Yusuf, Salim; Aboyans, V.; Ha, J.; Keltai, K.; Lamy, A.; Liu, L.; Moayyedi, P.; Sharma, M.; Stoerk, S.; Varigos, J.; Bhagirath, V.; Bogaty, P.; Botto, F.; Catanese, L.; Donato Magno, J.; Fabbri, G.; Gabizon, I.; Gosselin, G.; Halon, D.; Heldmann, M.; Lamelas, P.; Lauw, M.; Leong, Y.; Liang, D.; Lutay, Y.; Maly, M.; Mikulik, R.; Nayar, S.; Ng, K.; Perera, K.; Pirvu, O.; Ronner, E.; Sato, S.; Smyth, A.; Sokolova, E.; Wiendl, M.; Winkelmann, B.; Yang, X.; Yufereva, Y.; Cairns, J.; Sleight, P.; deMets, D.; Momomura, S. I.; Prins, M. [=Martin H.; Ramsay, T.; Goto, S.; Rouleau, J. L.; Schumi, J.; Thabane, L.; Casanova, A.; Bangdiwala, S.; Deng, E.; Dyal, L.; Khatun, R.; Marsden, T.; Pogue, J.; Tang, C.; Wong, G.; Yuan, F.; Aman, S.; Ariz, A.; Ashton, H.; Belanger, J.; Belanger, M.; Brettell, K.; Chandra, J.; Choppick, C.; Cisternino, D.; Cuncins-Hearn, A.; Di Marino, M.; Diao, L.; Dwomoh, S.; Dykstra, A.; Galatsis, E.; Gasic, T.; Gutierrez, J.; Hamilton, L.; Irwin, L.; Lapensee, C.; Li, A.; Lu, X.; MacRae, L.; Malik, S.; Malvestiti, A.; Mastrangelo, J.; Maystrenko, A.; O'Donnell, L.; Reeh, K.; Szymkow, P.; Thomas, S.; Thrasher, D.; Tyrwhitt, J.; White, L.; Bastone, R.; Berkowitz, S.; Dias, A.; Ho, K.; Keller, L.; Lanius, V.; Lister, K.; Merten, C.; Muehlhofer, E.; Schmidt, K.; Tasto, C.; Tsihlias, E.; Woroniecka-Osio, A.; Orlandini, A.; Niemann, G.; Pascual, A.; Toscanelli, S.; Cabezón, M.; Debaveye, B.; Meeusen, K.; Luys, C.; Broos, K.; Vandenberghe, K.; Luyten, A.; Oliveira, G. B. F.; Vila Nova, D. C.; Konishi, M. Y. N.; Lonn, A.; Turbide, G.; Cayer, M.; Rovito, C.; Standen, D.; Li, J.; Lopez Pico, M.; Dusek, R.; Buzalka, V.; Larsen, J.; Paucar, M. J.; Saarinen, M.; Simon, T.; Bezault, M.; Le Lay, M.; Epstein, L.; Fajardo-Moser, M.; Röser, C.; Putz-Todd, G.; Scheidemantel, F.; Poehler, D.; Renner, J.; Hargitai, A.; Doherty, A. O.; Duffy, N.; Roarty, C.; Nolan, A.; Power, A.; Yuval, R.; Ben Ari, M.; Greenblatt, S.; Marmor, Y.; Lucci, D.; Ceseri, M.; Baldini, E.; Cipressa, L.; Miccoli, M.; Goto, M.; Yamasowa, H.; Kajiwara, M.; Takase, D.; Ikeguchi, K.; Matsumoto, M.; Ishii, M.; Asai, J.; Nozaki, D.; Akatsuka, T.; Yoshida, T.; Shahadan, S.; Md Nasir, N.; Schut, Astrid; Vinck, Leonie; van Leeuwen, Marjelle; Sanchez, J.; Aquino, M. R.; Mararac, T.; Benedyk, K.; Iordache, A.; Ciobanu, A.; Rimbas, R.; Dragoi Galrinho, R.; Magda, S.; Mihaila, S.; Mincu, R.; Suran, B.; Cotoban, A.; Matei, L.; Kursakov, A.; Rusnak, P.; Zakharova, A.; Demidova, E.; Commerford, A.; Lee, S.; Ju, I.; Gunolf, M.; Lorimer, A.; Parkhomenko, L.; Johnson, J.; Anderson, J.; Norby-Slycord., C.; Sala, J.; Sicer, M.; Rasmussen, M.; Luciani, C.; Cartasegna, L.; Beltrano, C.; Medek, G.; Vico, M.; Lanchiotti, P.; Martella, C.; Hominal, M.; Castoldi, M.; Casali, W.; Raimondi, S.; Hasbani, E.; Prado, A.; Paterlini, G.; Waisman, F.; Leonard, M.; Caccavo, A.; Alarcon, V.; Zaidman, C.; Guerlloy, F.; Vogel, D.; Imposti, H.; Dominguez, A.; Hrabar, A.; Fernandez, A.; Schygiel, P.; Sokn, F.; Cuneo, C.; Gutierrez Carrillo, N.; Martinez, G.; Luquez, H.; Costantino, M.; Ruiz, M.; Beccetti, N.; Mackinnon, I.; Cluigt, N.; Ahuad Guerrero, R.; Fanuele, M.; Campisi, V.; Costabel, J.; Romanelli, M.; Bartolacci, I.; Echeverria, M.; Pedrotti, M.; Montaña, O.; Camino, A.; Crespo, C.; Barbieri, M.; Lopez Santi, R.; Tonin, H.; Heffes, R.; Gomez Vilamajo, O.; Vanesio, F.; Allegrini, E.; Garcia Duran, R.; Garcia, C.; Garcia Duran, L.; Schiavi, L.; Mana, M.; Bordonava, A.; Rodriguez, M.; Gutierrez, M.; Garrido, M.; Rodriguez, C.; Ingaramo, A.; Costamagna, O.; Almagro, S.; Gerbaudo, C.; Pelagagge, M.; Bustamante Labarta, M.; Novaretto, L.; Maldini, A.; Lopez, L.; Albisu Di Gennero, J.; Ibanez Saggia, L.; Garcia Vilkas, A.; Alvarez, M.; Stoermann, W.; Vita, N.; Vottero, E.; Macin, S.; Cocco, M.; Onocko, M.; Dran, R.; Gimenez, C.; Cardona, M.; Guzman, L.; Guzman, P.; Martinez, D.; Sarjanovich, R.; Huerta, C.; Scaro, G.; Cuadrado, J.; Rodriguez, G.; Nani, S.; Guardiani, F.; Litvak Bruno, M.; Ceconi, G.; Chacon, C.; Casado, M.; Fernandez Moutin, M.; Maffei, L.; Sassone, S.; Yantorno, M.; Grinfeld, D.; Vensentini, N.; Rolandi, F.; Fallabrino, L.; Majul, C.; Paez, O.; Visser, M.; Luciardi, H.; Mansilla, V.; Gonzalez Colaso, P.; Ferre Pacora, F.; Jure, H.; Parody, M.; Espeche, E.; Whelan, A.; Boyle, A.; Collins, N.; Roberts-Thomson, P.; Rogers, J.; Caroll, P.; Colquhoun, D.; Williams, L.; Shaw, J.; Blombery, P.; Amerena, J.; Lee, C.; Hii, C.; Royse, A.; Royse, C.; Singh, B.; Selvanayagam, J.; Jansen, S.; Thompson, P.; Lo, W.; Hammett, C.; Poulter, R.; Graves, S.; Narasimhan, S.; van den Heuvel, P.; Wollaert, B.; Sinnaeve, P.; Fourneau, I.; Meuris, B.; Vanassche, T.; Ector, B.; Janssens, L.; Debonnaire, P.; Vandekerckhove, Y.; van de Borne, P.; Wautrecht, J.; Motte, S.; Leroy, J.; Schroë, H.; Vrolix, M.; Ferdinande, B.; Vranckx, P.; Benit, E.; Elegeert, I.; Lerut, P.; Wallaert, P.; Hoffer, E.; Borgoens, P.; Dujardin, K.; Brasil, C. K. O. I.; del Monaco, M. I.; Uint, L.; Pavanello, R.; Precoma, D. B.; Vianna, H. S.; Abrantes, J.; Morelli, J.; Manenti, E.; Jaeger, C.; Reis, G.; Giorgeto, F. E.; França, C. C. B.; Quadros, T. F. S.; Saraiva, J.; Costa, M.; de Camargo, O.; Marson Lopes, M.; Silva, J.; Maia, L. N.; Nakazone, M. A.; Mouco, O. M. C. C.; Lemos, M. A. B. T.; Hernandes, M. E.; Pântano, G. S.; de Castro, J. C. M.; Rossi, P. R. F.; Guedes, A. A. M.; Dos Santos, L. B.; dos Santos, F. R.; Vidotti, M. H.; Zimmermann, S. L.; Rech, R.; Nunes, C.; Abib, E.; Oliveira, K. L. C.; Leaes, P. E.; Botelho, R. V.; Navarro, A. L. C.; Silva, R. A.; Arantes, F. B. B.; Dutra, O.; Vaz, R.; Souza, W. K. S. B.; Souza, A. S. B.; Queiroz, W. C. B.; Braile, M.; Ferreira, V.; Izukawa, N. M.; Prakasan, A. K.; Nicolau, J. C.; Dalçóquio, T. F.; Tanajura, L. F. L.; Serrano, C. V.; Hueb, W. A.; Minelli, C.; Borsetti Neto, F. A.; Nasi, L. A.; Martins, S. C. O.; Oliveira, L. F. A.; Silva, M. A. V.; Ferreira, J. O.; de Carvalho Cantarelli, M. J.; Tytus, R.; Pasyk, E.; Pandey, A. S.; Rowe, A.; Cha, J.; Vizel, S.; Babapulle, M.; Semelhago, L.; Saunders, K.; Haligowski, D.; Berlingieri, J.; Nisker, W.; Kiaii, B.; Romsa, J.; Chu, M.; Nagpal, D.; Guo, R.; Mckenzie, N.; Quantz, M.; Bhargava, R.; Bhargava, M.; Mehta, P.; Hill, L.; Heslop, W.; Fell, D.; Hess, A.; Zadra, R.; Zeman, P.; Srivamadevan, M.; Lam, A.; Tai, S.; Al-Qoofi, F.; Spence, F.; Anderson, T.; Kieser, T.; Kidd, W.; Fedak, P.; Smith, E.; Har, B.; Brown, C.; Forgie, R.; Hassan, A.; Pelletier, M.; Searles, G.; Marr, D.; Bessoudo, R.; Douglas, G.; Legare, J.; Petrella, R.; Pavlosky, W.; Ricci, J.; Galiwango, P.; Janmohamed, A.; Kassam, S.; Mukherjee, A.; Vijayaraghavan, R.; Burstein, J.; D'Mello, N.; Glanz, A.; Noiseux, N.; Stevens, L. M.; Basile, F.; Prieto, I.; Normandin, L.; Helou, J.; Do, Q. B.; Bainey, K.; Tymchak, W.; Welsh, R.; Merali, F.; Pandith, V.; Heffernan, M.; Orfi, J.; Mcconachie, D.; Jedrzkiewicz, S.; Della Siega, A.; Robinson, S.; Nadra, I.; Poirier, P.; Dagenais, F.; Voisine, P.; Mohammadi, S.; Doyle, D.; Baillot, R.; Charbonneau, E.; Dumont, E.; Kalavrouziotis, D.; Perron, J.; Jacques, F.; Laflamme, M.; Brulotte, S.; Crete, M.; Degrâce, M.; Delage, F.; Grondin, F.; Lemieux, A.; Michaud, N.; Saulnier, D.; Ross, M. K.; Nguyen, M.; Harvey, R.; Daneault, B.; Hartleib, M.; Guzman, R.; Nguyen, T.; Singal, R.; Bourgeois, R.; Landry, D.; Kamel, S.; Rupka, D.; Kuritzky, R.; Khaykin, Y.; Phaneuf, D. C.; Desjardins, V.; Coll, X.; Huynh, T.; Pilon, C.; Mansour, S.; Lemire, F.; Kokis, A.; Potvin, J.; Campeau, J.; Audet, M.; Boulianne, M.; Dupuis, R.; Lauzon, C.; Pruneau, G.; Senay, B.; Pichette, F.; Cieza, T.; Breton, R.; Belisle, P.; Barabas, M.; Diaz, A.; Costa, R.; Absi, F.; Garand, M.; Rheault, A.; Lemay, C.; Gisbert, A.; Raymond, A.; Barrero, M.; Gagne, C. E.; Rheault, P.; Pepin-Dubois, Y.; Johnston, J.; Mundi, A.; Cohen, G.; Shukle, P.; Baskett, R.; Hirsch, G.; Ali, I.; Stewart, K.; Fenton, J.; Pudupakkam, S.; Willoughby, R.; Czarnecki, W.; Roy, A.; Montigny, M.; Descarries, L.; Mayrand, H.; Comtois, H.; Essiambre, R.; Ringuette, G.; Boutros, G.; Gendreau, R.; Pham, L.; Nguyen, V.; Nguyen-Thanh, H. K.; Ben-Yedder, N.; Nawaz, S.; Fremes, S.; Moussa, F.; Shukla, D.; Labonte., R.; Jano, G.; Bobadilla, B.; Saavedra, J.; Bahamondes, J.; Cobos, J.; Grunberg, E.; Corbalan, R.; Verdejo, H.; Medina, M.; Vega, M.; Nahuelpan, L.; Castañia, F.; Raffo, C.; Vargas, A.; Reyes, T.; Vargas, D.; Perez, L.; Arriagada, G.; Potthoff, S.; Godoy, J.; Stockins, B.; Larenas, G.; Quiñinao, F.; Sepulveda, P.; Trucco, V.; Pincetti, C.; Saavedra, S.; Silva, P.; Vejar, M.; Rodríguez, T.; Rodriguez, J.; Tian, H.; Zhang, J.; Meng, Y.; Wu, X.; Wu, Q.; Wang, Q.; Mu, Y.; Yang, J.; Wang, F.; Zhang, W.; Ke, Y.; Jiang, H.; Yin, P.; Jia, K.; Chen, C.; Wang, Z.; Qi, B.; Yu, L.; Feng, G.; Li, L.; Jiang, L.; Wu, S.; Yu, H.; Wu, Z.; Ding, R.; Liu, S.; Xu, H.; Cao, H.; Bai, X.; Zheng, Y.; Liu, Z.; Sun, H.; Yang, P.; Li, B.; Feng, Z.; Yang, Y.; Xu, Z.; Wu, W.; Meng, Q.; Ge, J.; Dai, Y.; Yang, H.; Chen, X.; Tian, X.; Shi, Y.; Hu, T.; Zhang, R.; Zhao, Q.; Quan, W.; Zhu, Y.; Zheng, Z.; Zhang, S.; Zhao, Y.; Zhao, C.; Wang, R.; Tao, L.; Hu, D.; Wang, Y.; Fan, F.; Huang, W.; Xia, X.; Fu, G.; Jiang, D.; Wang, M.; Li, C.; Xu, K.; Dong, Y.; Chen, Y.; Wu, D.; Wang, C.; Sun, X.; Lu, S.; Zhou, X.; Kong, Y.; Zhang, B.; Sotomayor, A.; Suarez, M.; Ripoll, D.; Herrera, O.; Accini Mendoza, J.; Saad Cure, C.; Reyes, M.; Vidal, T.; Donado Beltran, P.; Hernandez Jaimes, E.; Castillo, H.; Rocha, C.; Forero, L.; Zarate Bernal, D.; Vanstrrahle Gonzalez, L.; Urina Triana, M.; Quintero, A.; Ramirez, N.; Balaguera Mendoza, J.; Aroca Martinez, G.; Cotes, C.; Mercado, A.; Lastra Percy, X.; Perez Mayorga, M.; Rodriguez, N.; Molina de Salazar, D.; Perez Agudelo, J.; Lopez Villegas, L.; Agudelo Ramos, L.; Melo Polo, M.; Esparza Albornoz, A.; Forero Gomez, J.; Sanchez Vallejo, G.; Aristizabal, J.; Gallego, A.; Contreras, C.; Yepez, J.; Angel Escobar, J.; Manzur J, F.; Cohen, L.; Boneu, D.; Garcia Lozada, H.; Barrios, L.; Celemin, C.; Diego, M.; Garcia Ortiz, L.; Montoya, C.; Ramirez, E.; Arcos Palma, E.; Ceron, J.; Acosta, G.; Gomez Mesa, J.; Velasquez, J.; Barreto, D.; Trujillo Dada, F.; Trujillo Accini, F.; Cano, R.; Corredor de La Cruz, K.; Maria, V.; Palmera, J.; Vesga, B.; Hernandez, H.; Moreno Silgado, G.; Aruachan Vesga, S.; Burgos Martinez, E.; Quintero Villareal, G.; Solano Ayazo, F.; Porto Valiente, J.; Zidkova, E.; Krupicka, P.; Bultas, J.; Mandysova, E.; Lubanda, J.; Horak, J.; Belohlavek, J.; Kovarnik, T.; Gorican, K.; Rucka, D.; Smid, O.; Dostalova, G.; Skalicka, H.; Karetova, D.; Pavlinak, V.; Kuchynkova, S.; Marek, J.; Rob, D.; Ravlykova, K.; Prochazka, P.; Siranec, M.; Urbanec, T.; Vareka, T.; Nesvadbova, P.; Kaletova, M.; Indrakova, J.; Kryza, R.; Heczko, M.; Hanak, P.; Jancar, R.; Kocurkova, L.; Marcinek, G.; Cermak, O.; Drasnar, T.; Richter, M.; Kaspar, J.; Spinar, J.; Parenica, J.; Parenicova, I.; Schildberger, J.; Toman, O.; Ludka, O.; Poloczek, M.; Musil, V.; Miklik, R.; Labrova, R.; Lokaj, P.; Felsoci, M.; Bocek, O.; Kanovsky, J.; Zatocil, T.; Jerabek, P.; Matuska, J.; Jankovic, M.; Jankovicova, H.; Tesak, M.; Sulc, D.; Svacinova, H.; Radvan, M.; Bednar, J.; Motovska, Z.; Petr, R.; Fischerova, M.; Branny, M.; Vodzinska, A.; Cerny, J.; Indrak, J.; Sknouril, L.; Maly, J.; Vacek, T.; Prazak, O.; Broulikova, K.; Hajsl, M.; Jarkovsky, P.; Kamenik, L.; Kotik, I.; Krcova, E.; Sedlon, P.; Skvaril, J.; Cernohous, M.; Kohoutek, J.; Levcik, M.; Holek, M.; Hajdusek, P.; Foltynova Caisova, L.; Novak, V.; Kladivkova, M.; Slaby, J.; Houra, M.; Vojtisek, P.; Novotny, V.; Lazarak, T.; Pliva, M.; Pirk, J.; Barciakova, L.; Jandova, R.; Adamkova, V.; Galovcova, M.; Peterkova, L.; Turek, D.; Prochazka, J.; Belohoubek, J.; Spinarova, L.; Panovsky, R.; Novotny, P.; Krejci, J.; Hude, P.; Ozabalova, E.; Godava, J.; Honek, T.; Kincl, V.; Benesova, M.; Buckova, J.; Canadyova, J.; Mokracek, A.; Homza, M.; Stverka, P.; Florian, J.; Lukac, B.; Polasek, R.; Kucera, P.; Seiner, J.; Karasek, J.; Coufal, Z.; Stastny, J.; Cernicek, V.; Skalnikova, V.; Jiresova, E.; Brat, R.; Sieja, J.; Gloger, J.; Berger, P.; Prochazkova, I.; Samlik, J.; Brtko, M.; Tuna, M.; Polansky, P.; Omran, N.; Myjavec, A.; Hrdinova, M.; Jansky, P.; Kratochvilova, R.; Burkert, J.; Koubek, F.; Fiala, R.; Paulasova Schwabova, J.; Lindner, J.; Hlubocky, J.; Spacek, M.; Marcian, P.; Hanak, V.; Pozdisek, Z.; Lonsky, V.; Santavy, P.; Troubil, M.; Straka, Z.; Budera, P.; Fojt, R.; Talavera, D.; Tretina, M.; Nemec, P.; Orban, M.; Bedanova, H.; Wiggers, H.; Tougaard, R.; Larsen, A.; Nielsen, H.; Mattsson, N.; Gunnar, G.; Bruun, N.; Folke, F.; Soendergaard, K.; Koeber, L.; Frydland, M.; Fuchs, A.; Bang, L.; Houlind, K.; Olsen, M.; Soerensen, V.; Overgaard Andersen, U.; Dixen, U.; Refsgaard, J.; Moeller, D.; Zeuthen, E.; Lund, J.; Soegaard, P.; Jensen, S.; Duarte, Y.; Duarte, W.; Cáceres, S.; Pow Chon Long, F.; Peñaherrera, C.; Anzules, N.; Sánchez, M.; Zuleta, I.; López, J.; Villota, M.; Sánchez, H.; Perugachi, C.; Gómez, S.; Morejón, P.; Mármol, R.; Guamán, S.; Trujillo, F.; Escobar, M.; Carrera, F.; Ponce, F.; Terán, P.; Carrasco, S.; Tuomilehto, J.; Humaloja, K.; Lindberg, L.; Tuomilehto, H.; Tuominen, M.-L.; Kantola, I.; Juliard, J.; Feldman, L.; Ducrocq, G.; Boulogne, C.; Petitalot, V.; Leclercq, F.; Roubille, F.; Agullo, A.; Ferrari, E.; Chiche, O.; Moceri, P.; Boccara, F.; Charbonnier, M.; Azeddine, B.; Ederhy, S.; Soulat Dufour, L.; Cohen, A.; Etienney, A.; Messas, E.; Calvalido, A.; Galloula, A.; Zarka, S.; Courtois, M.-C.; Mismetti, P.; Accassat, S.; Buchmuller, A.; Moulin, N.; Bertoletti, L.; Seffert, B.; Sevestre, M.; Samy Modeliar Remond, S.; Dupas, S.; Mardyla, J.; Le Gloan, S.; Cayla, G.; Cornillet, L.; Schmutz, L.; Motreff, P.; Souteyrand, G.; Amonchot, A.; Barber-Charmoux, N.; Combaret, N.; Malcles, G.; Brenner, S.; Christa, M.; Duengen, H.; Krackhardt, F.; Bobenko, A.; Hashemi, D.; Stellbrink, C.; Stellbrink, E.; Köster, C.; Guerocak, O.; Bourhaial, H.; Oumbe Tiam, S.; Kemala, E.; Froemke, J.; Kadel, C.; Moellinger, H.; Friedrich, K.; Rafoud, K.; Braun-Dullaeus, R.; Herold, J.; Ganzer, M.; Jeserich, M.; Kimmel, S.; Haggenmiller, S.; Schoengart, H.; Voehringer, H.; Opitz, C.; Appel, K.; Appel, S.; Utech, A.; Finger, C.; Duersch, M.; Dorsel, T.; Wistorf, N.; Grude, M.; Nikol, S.; Ueberschaer, D.; Kast, P.; Darius, H.; Sommer, S.; Girke, F.; Oeztuerk, C.; Ranft, J.; Mikalo, A.; Schellong, S.; Voigts, B.; Mueller, C.; Jungmair, W.; Davierwala, P.; Misfeld, M.; Bomke, K.; Akhavuz, O.; Haensig, M.; Vorpahl, M.; Blem, A.; Langer, G.; Nover, I.; Koehler, T.; Bajnok, L.; Marton, Z.; Laszlo, Z.; Noori, E.; Veress, G.; Fogarassy, G.; Aradi, D.; Kelemen, B.; Vertes, A.; Davidovits, Z.; Zsary, A.; Kis, E.; Hepp, T.; Koranyi, L.; Peterfai, E.; Bezzegh, K.; Bakai, J.; Agardi, I.; Boda, Z.; Razso, K.; Poor, F.; Varallyay, Z.; Jarai, Z.; Sallai, L.; Dudas, M.; Barton, J.; Mahmood, K.; Makki, H.; McAdam, B.; Salim, T.; Murphy, A.; Crean, P.; Liddy, A. M.; Mahon, N.; Khan, I.; Hassan, S.; Curtin, R.; McFadden, E.; MacNeill, B.; Kyvelou, S.; Canavan, M.; Veerasingam, D.; Dinneen, S.; Halabi, M.; Rosenfeld, I.; Levinas, T.; Goldberg, A.; Khateeb, A.; Zimlichman, R.; Ben-Aharon, J.; Beniashvili, A.; Betsalel, A.; Zeltser, D.; Rogowski, O.; Mardi, T.; Rozenbaum, Z.; Turgeman, Y.; Or, T.; Rabkin, Y.; Klainman, E.; Halabi, S.; Halon, D. A.; Katz, A.; Plaev, T.; Drogenikov, T.; Atar, S.; Kilimnik, M.; Wishniak, A.; Merei, M.; Zvi, Y.; Nikolsky, E.; Zukermann, R.; Petcherski, S.; Bosi, S.; Gaitani, S.; Naldi, M.; Barbieri, A.; Faggiano, P.; Guidetti, F.; Adamo, M.; D’Aloia, A.; Magatelli, M.; Robba, D.; Mos, L.; Vriz, O.; Sinagra, G.; Maras, P.; Doimo, S.; Cosmi, F.; D'Orazio, S.; Oltrona Visconti, L.; Leonardi, S.; Vullo, E.; Sbaffi, A.; Azzara, G.; Mauri, S.; Gianni, U.; de Matteis, C.; Campidonico, U.; Di Pasquale, G.; Di Niro, M.; Riva, L.; Filippini, E.; Di Biase, M.; Ieva, R.; Martone, A.; Mandorla, S.; Regni, O.; Capponi, E. A.; Martinelli, S.; Bernardinangeli, M.; Proietti, G.; Piccinni, G. C.; Gualtieri, M. R.; Gulizia, M. M.; Francese, G. M.; Portale, A.; Galvani, M.; Ottani, F.; Capatano, O. G.; Conficoni, E.; Longhi, S.; Bachetti, C.; Venturi, F.; Capati, E.; Morocutti, G.; Bisceglia, T.; Fresco, C.; Baldin, M. G.; Gamba, C.; Olivieri, C.; Perna, G. P.; Battistoni, I.; Marini, M.; Cirrincione, V.; Ingrilli, F.; Kanno, T.; Ishii, Y.; Kohmura, C.; Igawa, T.; Izawa, K.; Daida, H.; Miyauchi, K.; Shimada, K.; Ohmura, H.; Ito, S.; Okazaki, S.; Konishi, H.; Miyazaki, T.; Hiki, M.; Kurata, T.; Suzuki, H.; Morimoto, R.; Yokoyama, M.; Yamamoto, T.; Okai, I.; Isoda, K.; Fujimoto, S.; Dohi, T.; Shimada, A.; Ozaki, Y.; Watanabe, E.; Kawai, H.; Naruse, H.; Takada, K.; Okuda, K.; Okumura, M.; Ishikawa, M.; Ohtsuki, M.; Ohta, M.; Sarai, M.; Koshikawa, M.; Kawai, M.; Miyagi, M.; Motoyama, S.; Matsui, S.; Ichikawa, T.; Kato, Y.; Nagahara, Y.; Muramatsu, T.; Hashimoto, Y.; Hoshino, N.; Harada, M.; Yamada, A.; Yoshiki, Y.; Motoike, Y.; Nomura, Y.; Miyajima, K.; Takatsu, H.; Nishimura, H.; Nagasaka, R.; Kawada, Y.; Miyamoto, N.; Seki, K.; Inoue, A.; Higashiue, S.; Kojima, S.; Kuroyanagi, S.; Furuya, O.; Komooka, M.; Yamamoto, S.; Wakabayashi, N.; Domae, H.; Ata, T.; Hashidomi, H.; Kawahara, R.; Hosokawa, S.; Hiasa, Y.; Otani, R.; Kishi, K.; Takahashi, T.; Yuba, K.; Miyajima, H.; Tobetto, Y.; Yoneda, K.; Ogura, R.; Kobayashi, H.; Takamura, T.; Enkou, K.; Ochi, Y.; Yamada, D.; Kuramochi, T.; Misumi, K.; Iiduka, D.; Hirose, M.; Tone, K.; Taniguchi, Y.; Ebihara, T.; Makino, M.; Yokota, M.; Nitta, M.; Udo, A.; Shimizu, S.; Fujii, K.; Iwakura, K.; Okamura, A.; Inoue, K.; Nagai, H.; Hirao, Y.; Tanaka, K.; Tanaka, N.; Yamasaki, T.; Oka, T.; Iwamoto, M.; Tanaka, T.; Nakamaru, R.; Okada, M.; Takayasu, K.; Sumiyoshi, A.; Inoue, H.; Kitagaki, R.; Ninomiya, Y.; Mizutomi, K.; Koizumi, I.; Funada, A.; Tagawa, S.; Kamide, S.; Saku, K.; Ideishi, M.; Ogawa, M.; Uehara, Y.; Iwata, A.; Nishikawa, H.; Ike, A.; Sugihara, M.; Imaizumi, S.; Fujimi, K.; Kawamura, A.; Sako, H.; Morito, N.; Morii, J.; Fukuda, Y.; Yahiro, E.; Matsunaga, A.; Matsumoto, N.; Noda, K.; Shiga, Y.; Nagata, Y.; Kimura, K.; Ebina, T.; Hibi, K.; Iwahashi, N.; Maejima, N.; Konishi, M.; Matsushita, K.; Minamimoto, Y.; Kawashima, C.; Nakahashi, H.; Kimura, Y.; Takahashi, H.; Matsuzawa, Y.; Kirigaya, J.; Sato, R.; Kikuchi, S.; Ogino, Y.; Kirigaya, H.; Kashiwase, K.; Hirata, A.; Takeda, Y.; Amiya, R.; Higuchi, Y.; Sakaguchi, T.; Nakano, T.; Matsusaki, N.; Suzuki, S.; Hayashi, T.; Nakatani, S.; Koide, M.; Kobayashi, T.; Hamanaka, Y.; Makino, N.; Sotomi, Y.; Abe, M.; Fujieda, H.; Hashimoto, K.; Teratani, Y.; Abe, Y.; Yokoyama, Y.; Higashino, H.; Okuda, H.; Yamazato, M.; Noda, T.; Arai, M.; Ono, K.; Hirose, T.; Iwama, M.; Warita, S.; Goto, Y.; Abe, S.; Kojima, T.; Yoshizane, T.; Tanihata, S.; Fujii, T.; Yagasaki, H.; Miwa, H.; Ishiguro, M.; Kato, T.; Watanabe, R.; Horio, S.; Mita, T.; Hirayama, A.; Watanabe, I.; Hiro, T.; Nakai, T.; Takayama, T.; Yoda, S.; Yajima, Y.; Okubo, K.; Okumura, Y.; Kato, M.; Fukamachi, D.; Aizawa, Y.; Sonoda, K.; Iida, K.; Sasaki, N.; Iso, K.; Takahashi, K.; Kougo, T.; Haruta, H.; Kurokawa, S.; Mano, H.; Nagashima, K.; Onaka, H.; Doi, H.; Hirano, N.; Okamoto, F.; Mori, K.; Ri, G.; Zushi, R.; Otsuka, K.; Inoko, M.; Haruna, T.; Nakane, E.; Miyamoto, S.; Izumi, T.; Honjo, S.; Ikeda, H.; Wada, Y.; Funasako, M.; Hayashi, H.; Hamasaki, A.; Sasaki, K.; Seko, Y.; Nakasone, K.; Hanyu, M.; Iwasaki, Y.; Iwasaki, K.; Ayano, S.; Hirokami, M.; Omoto, Y.; Sasaki, H.; Sato, H.; Yuda, S.; Okubo, M.; Matsuo, H.; Tsuchiya, K.; Kawase, Y.; Miyake, T.; Kondo, H.; Hattori, A.; Kikuchi, J.; Okamoto, S.; Hirata, T.; Kawamura, I.; Ota, H.; Omori, H.; Tanigaki, T.; Kamiya, H.; Sobue, Y.; Komoda, T.; Akatsuka, Y.; Yamamoto, M.; Isegawa, K.; Takanezawa, M.; Kataoka, C.; Imamaki, M.; Shibata, Y.; Yasuda, K.; Shimano, M.; Ozaki, R.; Morishita, Y.; Okabe, K.; Kondo, K.; Miura, A.; Manita, M.; Tabata, K.; Asahi, T.; Mashidori, T.; Higa, N.; Nakata, M.; Himi, T.; Matsudo, Y.; Sekine, T.; Hou, K.; Tonoike, N.; Hama, Y.; Tanaka, S.; Ge, B.; Takahara, M.; Ishimura, M.; Shikada, T.; Ueno, H.; Amemiya, H.; Hisamatsu, Y.; Sada, K.; Sato, T.; Harada, K.; Nakamura, T.; Ako, J.; Tojo, T.; Shimohama, T.; Kishihara, J.; Ishii, S.; Fukaya, H.; Meguro, K.; Nishino, Y.; Inoue, M.; Matsui, Y.; Omura, Y.; Kawakami, H.; Matsuoka, H.; Oshita, A.; Seike, F.; Kondo, N.; Miyoshi, T.; Yamada, Y.; Uchiya, T.; Kikuchi, Y.; Koretsune, Y.; Abe, H.; Shinouchi, K.; Nishida, H.; Yasumura, K.; Date, M.; Ueda, Y.; Iida, Y.; Idemoto, A.; Toriyama, C.; Yokoi, K.; Mishima, T.; Yamada, T.; Fukunami, M.; Morita, T.; Furukawa, Y.; Kawasaki, M.; Kikuchi, A.; Tamaki, S.; Seo, M.; Shirakawa, Y.; Ikeda, I.; Fukuhara, E.; Kawai, T.; Kayama, K.; Kawahira, M.; Tanabe, K.; Nakamura, J.; Shimomura, H.; Kudo, T.; Morisaki, S.; Ogura, Y.; Chazono, N.; Onoue, Y.; Matsumuro, Y.; Shirakawa, T.; Nishi, M.; Kinoshita, N.; Nakamura, R.; Miyai, N.; Ohta, K.; Sawanishi, T.; Takahashi, A.; Hada, T.; Nakajima, S.; Taniguchi, N.; Mizuguchi, Y.; Takahashi, Y.; Hashimoto, S.; Machida, M.; Hirabayashi, K.; Morimoto, S.; Higashino, Y.; Otsuji, S.; Takiuchi, S.; Yabuki, M.; Hasegawa, K.; Shishikura, D.; Ibuki, M.; Ishibuchi, K.; Nagayama, S.; Ishii, R.; Tamaru, H.; Yamamoto, W.; Utsu, N.; Miyakoshi, K.; Nakashima, D.; Tsukuda, K.; Ueda, K.; Nakano, A.; Fukuda, T.; Ikeda, S.; Tsuchiya, H.; Toshima, S.; Tateno, R.; Ishikubo, T.; Suguta, M.; Nakamura, S.; Funatsu, A.; Mizobuchi, M.; Tanaka, M.; Nagai, T.; Hirano, S.; Hashimoto, T.; Doi, T.; Shirasaka, A.; Takeda, S.; Sasaki, Y.; Ohya, H.; Hosokawa, A.; Nishina, N.; Koki, B.; Ando, K.; Hiramori, S.; Soga, Y.; Tomoi, Y.; Tohoku, S.; Shirai, S.; Hyodo, M.; Isotani, A.; Domei, T.; Kuramitsu, S.; Morinaga, T.; Hayashi, M.; Hiromasa, T.; Nagae, A.; Yamaji, Y.; Nakao, K.; Sakamoto, T.; Taguchi, E.; Tsurugi, T.; Tanaka, Y.; Suzuyama, H.; Koyama, J.; Nagano, M.; Okamatsu, H.; Kodama, K.; Nakamura, M.; Horibata, Y.; Sone, M.; Tsunemori, M.; Bando, M.; Nakayama, T.; Tanigaito, Y.; Nomoto, M.; Sawamura, T.; Unoki, T.; Lim, C. W.; Zainal Rashid, R.; Najme Khir, R.; Ibrahim, K. S.; Wan Azman, W. A.; Sridhar, G. S.; Watson, T.; Abu Kassim, Z.; Mahmood Zuhdi, A. S.; Abdul Hafidz, M. I.; Abu Hassan, M. R.; Wan Rahimi Shah, W. F.; Karthikesan, D.; Mohd Suan, M. A.; Md Ali, S. M.; Kasim, S.; Mohd Arshad, M. K.; Ismail, J. R.; Ibrahim, Z. O.; Chua, N. Y. L.; Abdul Rahim, A. A.; Rusani, B. I.; Yap, L. B.; Zamrin, D. M.; Amir, M. A.; Ismail, N. I.; Mohammad Razi, A. A.; Prins, F.; Bendermacher, P.; Burg, M.; Lok, D.; van der Sluis, A.; Martens, F.; Badings, E.; Milhous, J.; van Rossum, P.; Viergever, E.; van Hessen, M.; Willems, F.; Tjon Joe Gin, R.; Swart, H.; Oomen, A.; Kromhout, S.; Lauwerijssen, I.; Daalmans, M.; Breedveld, R.; de Vries, K.; Feenema Aardema, M.; Hofma, S.; van der Borgh, R.; van Nes, E.; Göbel, E.; Oei, F.; Dorman, H.; Bos, R.; Zoet-Nugteren, S.; Emans, M.; Kragten, H.; Lenderink, T.; Feld, R.; Herrman, J.; van Bergen, P.; Gosselink, M.; Elvan, A.; Hoekstra, E.; The, S.; de Vries, R.; Zegers, E.; Oude Ophuis, T.; Remmen, J.; Bech, J.; Kooistra, J.; den Hartog, F.; Oosterhof, T.; Bartels, G.; Posma, J.; Nierop, P.; Liem, A.; van der Zwaan, C.; Asselman, M.; van Eck, J.; Gevers, R.; van Gorselen, E.; van Hal, J.; Terpstra, W.; Groenemeijer, B.; Jerzewski, A.; Hoogslag, P.; Geertman, J.; de Groot, M.; Dijkstra, B.; Loyola, A.; Sulit, D.; Mercado, M. J.; Rey, N.; Evangelista, L.; Abola, M.; Padua, L.; Morales, D.; Palomares, E.; Abat, M.; Santos, R.; Rogelio, G.; Chua, P.; Baello, R.; del Pilar, J.; Alianza, M.; Alcaraz, J.; Alcaraz, L.; Ebo, G.; Guido-Saliot, I.; Tirador, L.; Estoce, E.; Ygpuara, M.; Cruz, J.; Anonuevo, J.; Pitargue, A.; Janion, M.; Drewniak, Z.; Guzik, B.; Nowak, M.; Nosal, M.; Niewiara, Ł; Gajos, G.; Bury, K.; Czubek, U.; Misztal, M.; Grzybczak, R.; Zalewski, J.; Kruszelnicka-Kwiatkowska, O.; Żabówka, M.; Rynkiewicz, A.; Grzybowski, A.; Szałkowski, P.; Broncel, M.; Gorzelak, P.; Możdżan, M.; Olszewska Banaszczyk, M.; Szuba, A.; Tabin, M.; Chachaj, A.; Czarnecka, D.; Terlecki, M.; Klocek, M.; Maga, P.; Coman, I.; Tarlea, M.; Ghionea, M.; Gavrila, C.; Dimulescu, D.; Popescu, A.; Stoicescu, C.; Vintila, V.; Florescu, M.; Baghilovici Cretu, D.; Suran, M.; Mihalcea, D.; Lungeanu Juravle, L.; Cinteza, M.; Calin, I.; Bicescu, G.; Vasile Toma, N.; Udroiu, C.; Gherghinescu, C.; Darabont, R.; Patrascu, N.; Constantinescu, C.; Popescu, I.; Sinescu, C.; Andrei, C.; Axente, L.; Arsenescu, C.; Statescu, C.; Ardeleanu, I.; Anghel, L.; Benedek, I.; Benedek, T.; Kinga, P.; Banga, D. K.; Bobescu, E.; Doka, B.; Dobreanu, D.; Sirbu, V.; Rudzik, R.; Kantor, K.; Sus, I.; Gaita, D.; Maximov, D.; Brie, D.; Mosteoru, S.; Olariu, I.; Iancu, A.; Marc, M.; Hagiu, R.; Manole, V.; Molnar, A.; Dregoesc, I.; Iliesiu, A.; Armean, P.; Parvu, I.; Deleanu, A.; Lighezan, D.; Buzas, R.; Petrescu, L.; Nicola, R.; Dan, R.; Crisan, S.; Trasca, L.; Teodorescu, I.; Zara, O.; Tiron, T.; Tesloianu, D.; Spiridon, M.; Vintila, M.; Baluta, M.; Chioncel, O.; Stoica, E.; Kulcsar, I.; Antohi, L.; Strazhesko, I.; Tkacheva, O.; Sharashkina, N.; Pykhtina, V.; Vasyuk, Y.; Shkolnik, E.; Khadzegova, A.; Sadulaeva, I.; Ivanova, S.; Nesterova, E.; Nesvetov, V.; Shupenina, E.; Shcherbak, M.; Sizova, Z.; Beloborodova, A.; Pozdnyakov, Y.; Tarasov, A.; Shvedov, I.; Zabashta, S.; Ryzhikova, I.; Barbarash, O.; Pecherina, T.; Vatutin, M.; Inozemceva, A.; Kazachek, Y.; Mineeva, E.; Kupriyanova, T.; Voevoda, M.; Gafarov, V.; Gromova, E.; Panov, D.; Voevoda, E.; Kovalkova, N.; Ragino, Y.; Poponina, T.; Poponina, Y.; Garganeeva, N.; Repin, A.; Vershinina, E.; Borodina, E.; Kalashnikova, T.; Safyanova, O.; Osipova, I.; Antropova, O.; Pyrikova, N.; Polyakova, I.; Efremushkina, A.; Guryanova, N.; Kiseleva, E.; Lomteva, E.; Shtyrova, T.; Novikova, N.; Parfenov, D.; Volovchenko, A.; Averkov, O.; Pavlikova, E.; Vaulina, L.; Pletnikova, I.; Mishchenko, L.; Saranin, S.; Tsupko, I.; Kuznetsova, N.; Zateyshchikov, D.; Dankovtseva, E.; Vlazneva, Y.; Tolokonnikova, N.; Zhurina, M.; Zubova, E.; Aseycheva, O.; Sigalovich, E.; Vertkin, A.; Rodiukova, I.; Komissarov, S.; Sokolova, R.; Ausheva, A.; Salbieva, A.; Yusubova, A.; Isakova, S.; Hranai, M.; Obona, P.; Cisar, P.; Semetko, J.; Vanova, P.; Ferencikova, Z.; Vykoukalova, T.; Gaspar, L.; Caprnda, M.; Bendzala, M.; Pella, D.; Fedacko, J.; Hatalova, K.; Drozdakova, E.; Peter, O.; Ntsekhe, M.; de Andrade, M.; Seedat, S.; Gani, M.; van Zyl, L.; Naude, M.; Cronje, T.; van Zyl, F.; Engelbrecht, J.; Jansen, J.; Roos, J.; Makotoko, E.; Pretorius, C.; Mirna, S.; Nell, H.; Pretorius, M.; Basson, M.; Njovane, X.; Mohamed, Z.; Pillay, T.; Dawood, S.; Horak, A.; Lloyd, E.; Hitzeroth, J.; Mabin, T.; Abelson, M.; Klug, E.; Gebka, M.; Hellig, F.; Alison, M.; Bae, J.; Kim, C.; Kim, D.; Joo, S.; Park, C.; Kim, Y.; Jarnert, C.; Rydén, L.; Mooe, T.; Binsell-Gerdin, E.; Dellborg, M.; Torstensson, I.; Albertsson, P.; Hiller, M.; Perers, E.; Johansson, L.; Jansson, J. H.; Al-Khalili, F.; Almroth, H.; Andersson, T.; Eriksson Östman, M.; Pantev, E.; Utter, F.; Tengmark, B. O.; Olsson, Å; Liu, B.; Rasmanis, G.; Wahlgren, C. M.; Thott, O.; Moccetti, T.; Rossi, M. G.; Crljenica, C.; Dovgan, N.; Skarzhevskyi, O.; Kozhukhov, S.; Tseluyko, V.; Mishchuk, N.; Kuznetsov, I.; Semenikhin, S.; Matviichuk, N.; Matuzok, O.; Yakovleva, L.; Volkov, V.; Zaprovalna, O.; Serik, S.; Riabukha, V.; Koval, O.; Kaplan, P.; Ivanov, A.; Romanenko, S.; Skoromna, A.; Kononenko, L.; Saprychova, L.; Lazareva, S.; Prokhorov, O.; Vdovychenko, V.; Bychkov, M.; Demydova, A.; Kapustynska, O.; Bazylevych, A.; Dutka, R.; Vlasyuk, Z.; Shabat, M.; Rudenko, L.; Beregova, O.; Fedtchouk, L.; Gusak, I.; Vizir, V.; Sadomov, A.; Shkolovoy, V.; Nasonenko, O.; Demidenko, O.; Karpenko, O.; Ponomarenko, K.; Oryshych, G.; Nevolina, I.; Mitskevych, L.; Bezuglova, S.; Kizim, S.; Todoriuk, L.; Brodi, N.; Karpenko, L.; Malynovsky, Y.; Fedotov, S.; Malynovska, O.; Goydenko, O.; Miroshnykov, S.; Rabota, I.; Koval, V.; Ohirko, O.; Khaba, U.; Storozhuk, B.; Danylchuk, I.; Danylchuk, A.; Gutsuliak, R.; Cotton, J.; Luckraz, H.; Wrigley, B.; Venkataraman, A.; Maher, A.; Moriarty, A.; McEneaney, D.; Connolly, D.; Davis, R.; Banerjee, P.; Davey, P.; Elmahi, E.; Senior, R.; Ahmed, A.; Birdi, I.; Gedela, S.; Singh, A.; Calvert, J.; Butler, M.; Donnelly, P.; Jasinka, A.; Orr, C.; Trevelyan, J.; Routledge, H.; Carter, J.; Oxenham, H.; Peace, A.; McNeill, A.; Austin, D.; Jackson, M.; Kukreja, N.; Kotwinski, P.; Hilton, T.; Bilizarian, S.; Srivastava, S.; Walsh, R.; Fields, R.; Portnay, E.; Gogia, H.; Deits, R.; Salacata, A.; Hunter, J.; Bacharach, J.; Shammas, N.; Suresh, D.; Gurbel, P.; Banerjee, S.; Grena, P.; Bedwell, N.; Sloan, S.; Lupovitch, S.; Soni, A.; Gibson, K.; Pepper, D.; Sangrigoli, R.; Mehta, R.; Patel, J.; I-Hsuan Tsai, P.; Gillespie, E.; Harrison, A.; Dempsey, S.; Phillips, R.; Hamroff, G.; Hametz, C.; Black, R.; Lader, E.; Kostis, J.; Bittner, V.; Mcguinn, W.; Cheng, R.; Pal, J.; Malhotra, V.; Michaelson, S.; Vacante, M.; Mccormick, M.; Arimie, R.; Dukkipati, R.; Camp, A.; Dagher, G.; Kosh y, N.; Culp, J.; Thew, S.; Ferraro, A.; Costello, F.; Heiman, M.; Chilton, R.; Moran, M.; Adler, F.; Balingit, P.; Comerota, A.; Seiwert, A.; French, W.; Vardi, G.; Singh, T.; Serota, H.; Qayyum, U.; Das, S.; Harrison, R.; Vora, A.; Bakeen, F.; Omer, S.; Chandra, L.; Casaccia, G.; Tinto, J.; Sighel, C.; Giozzi, E.; Morell, Y.; Bianchini, M.; Yossen, M.; Hoyos, M.; Venturini, C.; Merkusa, C.; Carrique, A.; Carrique, P.; Fracaro, V.; Torres, M.; Crunger, P.; Espinosa, M.; Passarello, A.; Zaidman, M.; Ledesma, M.; Troncoso, C.; Aviles, A.; Rodera Vigil, S.; Vogel, M.; Takla, M.; Funosas, C.; Ferreiro, M.; Bruno, T.; Buzzetti, C.; Lozano, J.; Alvarez Dámelio, A.; Bocanera, M.; Vicente, D.; Cenci, A.; Deluca, C.; Santana, R.; Ahuad Calvelo, A.; Alvarez D'Amelio, A.; Ahuad Calvelo, J.; Herrero, S.; Robertson, M.; Tapia, D.; Escalante, M.; Cañas, M.; Cendali, G.; Esposito, L.; Muñiz, M.; Montaña, J.; Di Vruno, M.; Strevezza, M.; Lopez Santi, M.; Massei, N.; Garate, V.; Perlo, D.; Campora, F.; Jakubowski, I.; Gonzalez Moisello, M.; Actis, M.; Schiavi, S.; Aguirre, M.; Ceirano, C.; Zillo, M.; Yunis, M.; Berdini, A.; Gerbaudo, R.; Berdini, J.; Palma, F.; Pinero, S.; Virulio, S.; Vitale, A.; Sosa Flores, G.; Ibanez Saggia, C.; Ibanez Saggia, D.; Roses, A.; Martinelli, C.; Vargas, L.; Galarza Salazan, M.; Dran, P.; Tinnirello, V.; Pelayes, S.; Bordoni, P.; Navarro, A.; Barilati, P.; Serra, R.; Nigro, A.; Cleiman, S.; Bianchi, M.; Vallejo, M.; Ingratta, M.; Tonelli, L.; Levantini, M.; Bonifacio, M.; Hansen, V.; Chaieb, A.; Majul, S.; Medina, F.; Gallinotti, P.; Madariaga, T.; Andrea, G.; Blumberg, C.; Volpe, M.; Gandur, H.; Benincasa, V.; Barreto, M.; Jure, D.; Tulloch, G.; Greenwell, D.; Forrest, N.; Nyman, E.; Mcintosh, C.; O'May, V.; Grabek, T.; Conway, B.; O’Donoghue, M.; Brady, L.; Duroux, M.; Ratcliffe, M.; Shone, S.; Connelly, A.; Ferreira-Jardim, A.; Vandernet, R.; Downes, R.; Davids, F.; Teal, L.; Knight, S.; Soraghan, D.; Spence, C.; Smith, K.; Tivendale, L.; Williams, Z.; O'Connor, M.; Walker, I.; Ferguson, L.; Holiday, J.; Griffin, R.; Palethorpe, L.; Hindom, L.; Lilwall, L.; Wadham, S.; Narasimhan, K.; van Extergem, P.; Joris, I.; Oreglia, M.; Jacobs, C.; Leus, W.; Robesyn, V.; Vanheule, K.; van den Bossche, K.; Albertijn, S.; Vissers, C.; Badts, G.; Vangenechten, K.; Derycker, K.; Dejaegher, K.; de Grande, T.; de Clippel, M.; Gayet, F.; Jorion, M.; Jourdan, A.; Tartaglia, K.; Zwinnen, W.; Roijakkers, I.; van Genechten, G.; Schoonis, A.; Bollen, J.; Janssen, A.; de Coninck, M.; Ruell, S.; Grimonprez, A.; Bouckaert, N.; van Eeckhoutte, H.; Malmendier, D.; Massoz, M.; Jacquet, S.; Vanhalst, E.; Casier, T.; Barroso, S. L.; Tamashiro, N.; Correa, C. P.; Sehnem, E. A. B.; Precoma, C. B.; Pinheiro, L.; Ruschel, K. B.; dos Reis, A. L.; Santos, M. S.; de Oliveira, L. O. S. P.; de Carvalho, L. M. G.; dos Santos, M. E. S.; Reis, L. L. F.; da Cunha, G. T.; França, F. F.; Bessa, S. K.; Vicente, C.; Ormundo, C.; Trama, L.; Pires, N. F.; Esteves, D.; Sila, O. L.; Góes, N. C.; Amorin, R. C.; Faria, M. O.; Bucalon, E. C.; Marin, L. P.; Herek, L.; Araujo, V. L.; Silva, A. F.; Lima, F.; Gomes, C. G.; Pagnan, L. G.; Novelli, C. M.; Carvalho, J. K. C.; Teodoro, A. R.; Zimmermann, E. M. B.; Beiersdorf, J. R.; Machado, B. G.; Pedroso, F. B. V.; de Vargas, T.; Peres, C. S.; dos Santos, T. F.; de Souza, S. F.; Luiz, R. O.; Ferreira, P.; Souza, D. F.; Cunha, S. M. C.; de Resende, I. M.; Furtado, C. C. F.; Soprane, A. A.; Brum, A. B.; Zorzo, J. A. T.; dos Santos, J. C.; Queiroz, L. B.; Barros, F. E.; Vianna, C. O.; Zanateli, A.; Vieira, A. P. Z.; Melo, G.; Zambonin, G. E. C.; Paiva, P.; Viana, R. M. M.; Yagihara, M. M.; Takiuti, M. M.; Miyamoto, P. B.; da Silva, M. F.; Borin, L. A.; Chiazzini, S. M. L.; Fleck, N.; Batista, R. F.; Cardoso, D. T.; MCamasmie, P.; Assompção, R. P.; Marques, L. L.; Leung, S.; Lewis, C.; Tytus, A.; Clarus, S.; Juranics, S.; Pandey, M.; Frenette, L.; Magi, A.; Nowacki, B.; Otis, J.; Fox, B.; Corke, R.; Miller, B.; Rizzo, A.; Trombetta, L.; Power, P.; Richert, L.; Haligowski, R.; Macrae, C.; Kooistra, L.; Urso, C.; Fox, S.; Felbel, S.; Stafford, C.; Stata, C.; Barnabe, B.; Mehta, K.; Faul, J.; Gohel, J.; Bhakta, S.; Harwood, A.; McPherson, C.; Marucci, J.; Manasterski, L.; Veenhuyzen, J.; Ramadan, D.; Madden, B.; Jetha, A.; Pajevic, M.; Dube, C.; Rolfe, B.; O’Blenis, G.; Roy, L.; Dihel, C.; Butler, J.; Simmavong, K.; Bartol, C.; Bozek, B.; Hart, B.; Shier, M.; Coughlin, M.; Lamantia, C.; Lamantia, D.; Vilag, C.; Fecteau, J.; Dionne, J.; Péloquin, G.; Hogg, N.; Welsh, S.; Weerasingam, S.; Lantz, M.; Lounsbury, N.; Martin, E.; Mitchell, L.; Morgen, G.; Nelson, S.; Pelzer, E.; Sorensen, S.; Leblanc, A.; Bourlaud, A. S.; Prémont, A.; Léger, P.; Larivière, M. M.; Tremblay, H.; Bergeron, A.; Dumont, J.; Keilani, S.; Landry, P.; Deneufbourg, I.; Breton, C.; Bilodeau, N.; Côté, M.; Dumont, F.; Dufort, L.; Marcoux, D.; David, M.; Otis, R.; Parks, J.; Cepidoza, C.; Janz, W.; Weighell, W.; Yaworski, S.; Boyd, K.; Lambert, J.; Shea-Landry, G.; Reid, K.; Thiessen, S.; Nemtean, D.; Futers, S.; Drouin, K.; Masson, C.; Arseneault, M. C.; Lachance, N.; Bergeron, C.; Boudreault, C.; Perkins, L.; Barnett, A.; Fortin, J.; Duclos, R.; Vallières, C.; Bouchard-Pilote, C.; Ouimet, F.; Roberge, B.; Couture, M. L.; Deshaies, D.; Bastien, A.; Chartrand, M. J.; Gagné, N. L.; Desbiens, K.; Alarie, P.; Cassan, J.; Ducharme, Y.; Roy D Tapps, I.; Bolduc, H.; Laliberté, J.; Hickey, L.; Spero, M.; Bernstein, M.; Clement, J.; Pawluch, A.; Ricci-Bonzey, M.; Richer, J.; Vaillancourt, J.; Ward, B.; Mostafai Rad, P.; Oleski, L.; Karkhanis, R.; Hartleib, V.; Poirier, R.; Hidalgo, J.; Hernandez, C.; Obreque, C.; Quilapi, D.; Villa, F.; Iturriaga, C.; Ferrada, M.; Navarrete, S.; Becerra, E.; Vargas, C.; Roque, C.; Alarcon, J.; Diaz, D.; Sepulveda, M.; Villan, C.; Garcia, N.; Lara, C.; Lezana, B.; Basso, N.; Torres, G.; Pasmino, C.; Gonzalez, S.; Medina, D.; Rodriguez, T.; Guo, T.; Chen, S.; Han, W.; Shi, D.; Zhang, Q.; Li, W.; Cui, L.; Huang, Z.; Gong, X.; Liu, D.; Tan, S.; Caicedo, L.; Rodriguez, A.; Mejia, I.; Escalante Ruiz, J.; Camera Ochoa, C.; Conrrado Ortega, Y.; Accini Diaz, A.; Rodriguez, B.; Lopez-Lopez, J.; Di Stefano, K.; Florez, L.; Manco, T.; Rodriguez, D.; Urina, A.; de La Hoz, L.; Almendrales, L.; Bello, O.; Urrea Valencia, H.; Correa Rivera, P.; Perdomo, I.; Alzate, J.; Rivera, E.; Jimenez, N. N.; DMoreno, N.; Guzman, A.; Betancourt, S.; Mendoza Marin, H.; Leyva, M.; Ortiz, M.; Marin, E.; Angie Lorena, A.; Alvarez, Y.; Cervantes Hurtado, A.; Accini Mendoza, A.; Trujillo Accini, M.; Eguis, B.; del Portillo, C.; Ortega, M.; Delgado, P.; Arciniegas, J.; Rodriguez, L.; Melo Sanchez, S.; Chavera, I.; Pastrana Mendoza, M.; Negrette Quintero, A.; Zidek, M.; Hajkova, D.; Rozskowska, P.; Opavska, I.; Souckova, E.; Matuskova, E.; Kratochvilova, T.; Pavelec, P.; Zelenkova, V.; Dolezalova, Z.; Márquez, M.; Moreira, D.; Zuleta, M.; Santana, G.; Coello, A.; Andrade, G.; Salazar, J.; Rivadeneira, J.; Vaerma, J.; Lappalainen, S.; Silvennoinen, S.; Haaraoja, A.; Valimaki, S.; Roine, E.; Abergel, H.; Msakni, W.; Fuentes, A.; Briday, G.; David, A.; Soltani, S.; Decorps, A.; Chettouh, M.; Douillet, M.; Zamiti-Smondel, A.; Cuccu, L.; Salhi, N.; Helene, M.; Martin, S.; Merah, A.; Daher, P.; Laurie, S.; Roussel, L.; Leperchois, C.; Delelo, E.; Thalamy, A.; Chazot, E.; Tahirovic, E.; Watson, S.; Brettschneider, B.; Maas, M.; Euler, K.; Rahn, G.; Beissner, S.; Anuschek, V.; Tu, E.; Buerger, M.; Schemann, J.; Klinger, C.; Kurzidim, T.; Sahbani, S.; Laszig, S.; Beilfuss, M.; Foerster, A.; Eichinger, G.; Rupprecht, M.; Kuehnert, J.; Wendler-Huelse, I.; Buelow-Johansen, B.; Baierlein, A.; Iselt, M.; Sievert, B.; Frommhold, R.; Wolf, T.; Hahn, M.; Schoen, B.; Acimic, C.; Ludwig, M.; Funkat, A.; Wagner, I.; Schink, M.; Calvo-Sanchez, D.; Felfoldine Feil, J.; Patakine Sumegi, T.; Miko-Pauer, R.; Courcy, M.; Kelly, C.; Farrell, D.; Kirrane, C.; Hall, M.; Gilroy, E.; Kelsey, M.; Andrew, G.; Joyce, M.; Conway, S.; Duane, L.; Omer, T.; Zuker, S.; Platner, N.; Saranga, H.; Kaufman, E.; Livshitz, L.; Genin, I.; Klainman, M.; Uziel Iunger, K.; Abitbul, A.; Fishman, B.; Greenshtein, I.; Tubul, O.; Lasri, E.; Zvi, R.; Yablonski, A.; Helmer Levin, L.; Lunetto, M. L.; Savoldi, D.; Fiorini, M.; Ramani, F.; Mariottoni, B.; Rizzotti, D.; Di Matteo, C.; Musio, S.; Pieroni Minciaroli, S.; Serani, S.; Aloisi, A.; Attanasio, C.; Tricoli, M.; Giordano, V.; Andrioli, V.; Biundo, V.; Tullio, L.; Schiff, D.; Trovarelli, P.; Chiodi, R.; Sampaolesi, S.; Cina, M. T.; Abatello, M.; de Tora, M.; Pietrucci, F.; Pezzetta, S.; Chiminelli, E.; Dall’Asta, A.; Bennati, M.; Elia, A.; Bizzoco, M.; Iaquaniello, A.; Spigarelli, R.; Cremonesi, C.; Gagliardi, M.; Torricelli, L.; Ijichi, N.; Shiraiwa, K.; Murakami, M.; Takeshita, K.; Sato, M.; Shiratori, A.; Kinjo, K.; Tomita, K.; Mizuno, M.; Kurihara, F.; Tachibana, M.; Nitta, Y.; Unno, K.; Hiramatsu, H.; Sano, A.; Nanatsumura, M.; Tanikawa, I.; Uesugi, K.; Banno, S.; Miyata, T.; Kujuji, A.; Kawai, K.; Maegawa, A.; Koseki, T.; Watanabe, Y.; Aoki, S.; Maesawa, M.; Suzuki, A.; Itose, Y.; Konishi, K.; Fujieda, K.; Nakade, S.; Minami, M.; Yoneda, J.; Akiyama, R.; Sakai, S.; Nakatani, K.; Yamazaki, A.; Funama, M.; Kaneko, E.; Morii, S.; Onishi, M.; Sone, A.; Sagawa, N.; Iwai, F.; Kawahara, A.; Hasimoto, C.; Ueki, M.; Kamiji, M.; Ando, M.; Yokoo, M.; Okada, Y.; Yamada, H.; Matsushige, N.; Nagato, A.; Matsumoto, R.; Nishikawa, M.; Oka, I.; Kitou, S.; Tachiuchi, M.; Nakagawa, M.; Yoneda, S.; Iwasa, K.; Matsuda, J.; Oda, A.; Tokudome, S.; Kaneyuki, Y.; Higaki, M.; Yoneda, H.; Kajita, C.; Suwa, K.; Sato, E.; Nagata, T.; Kubo, Y.; Umesu, A.; Ohashi, K.; Takeuchi, M.; Tanaka, I.; Nobehara, T.; Yamano, R.; Yumiba, A.; Hamada, M.; Nishihata, T.; Ohashi, Y.; Morita, M.; Endo, M.; Matsugi, M.; Tateishi, H.; Nakamori, R.; Yamashita, Y.; Okabe, M.; Matsuo, M.; Ono, T.; Shigeyama, Y.; Ichiyanagi, M.; Sugimori, K.; Ohmura, C.; Igarashi, M.; Aotsuka, S.; Komoda, N.; Watanabe, M.; Enomoto, Y.; Suzuki, Y.; Kawaguchi, A.; Kasahara, A.; Koide, A.; Sakatani, T.; Kurihara, T.; Yokota, S.; Futagi, R.; Amemiya, Y.; Ono, E.; Maeda, A.; Kadono, K.; Ishiguchi, Y.; Kikuchi, R.; Kuramatsu, M.; Nakamura, E.; Chiba, S.; Higa, A.; Kitahashi, M.; Tanaka, H.; Ito, T.; Oba, M.; Tsubouchi, M.; Toshima, M.; Morishita, M.; Miyano, A.; Kondo, M.; Watanabe, K.; Shibata, R.; Tosaki, Y.; Ito, Y.; Saoda, M.; Yamasaki, E.; Kadosaki, S.; Motooka, S.; Akiyoshi, H.; Morio, S.; Nemoto, H.; Yoshizawa, S.; Okabe, N.; Semba, K.; Yoshida, A.; Lee, Y.; Yoshida, M.; Iwashita, Y.; Takeda, A.; Maezato, M.; Kawahira, K.; Yoshikawa, M.; Okamoto, N.; Nishimura, M.; Matsuura, K.; Fukunaga, M.; Fukai, K.; Osakabe, Y.; Yamamura, K.; Koike, M.; Shibuya, S.; Shiramata, M.; Ono, Y.; Tsujimoto, Y.; Tadokoro, T.; Morishita, N.; Matsuo, Y.; Yumoto, I.; Sakazaki, S.; Atarashi, A.; Nabata, Y.; Okuda, N.; Fujita, A.; Matsuo, A.; Ishizawa, Y.; Shibata, H.; Ootsuka, M.; Taimatsu, R.; Takeuchi, A.; Sumi, Y.; Yamamoto, F.; Araki, Y.; Tanaka, A.; Kuroda, S.; Sakata, R.; Okada, N.; Sawada, Y.; Miyata, M.; Asayama, H.; Koga, N.; Miki, T.; Yamaguchi, N.; Hashimoto, A.; Fukuike, C.; Kubo, A.; Yamasaki, M.; Mori, Y.; Nakayama, S.; Kobayashi, Y.; Takenaka, S.; Mashima, M.; Katsuta, H.; Matsumura, T.; Yanagida, S.; Watanabe, N.; Kodama, S.; Kusano, M.; Yamamoto, N.; Kamada, R.; Suzuki, K.; Itami, K.; Hasebe, Y.; Fujita, N.; Kubota, S.; Usuki, A.; Okamoto, M.; Uno, S.; Chikuma, A.; Kishikawa, H.; Yano K Nakano, C.; Otaguro, M.; Kayashima, Y.; Shinoda, M.; Jaafar, S. M.; Baharuddin, S.; Gembor, J.; Ahmad, H.; Syed Mansor, S. M.; Abdullah, W. M.; Shafie, Z.; Muhamad Yunus, S.; Alwi, S. M.; Hussin, N.; Basri, N. A.; Ling Ling, L.; Naem, N. S.; Rutten, R.; Rademaker, H.; van Buijsen, M.; Scholten, M.; Stuij, S.; van Zeijst, M.; van Houwelingen, K.; Engelen, W.; Kramer, H.; Maassen, E.; Verhoeven, P.; Awater, J.; Terwisscha van Scheltinga, C.; Meijlis, P.; Blom, L.; Bos, M.; van der Wal, M.; van Laerhoven, G.; Jacobs, T.; Tan-Urgert, B.; van de Gaag, J.; den Boer, P.; Verlek, E.; Lardinois, R.; Coenjaerds, C.; Hendrick, R.; Schoep, J.; Froma, E.; van Nes, C.; Beuving, D.; Krikken, J.; Drent, I.; Geerlings, F.; Buvelot, S.; Wissenburg, A.; Dijkshoorn, A.; van Setten van der Meer, L.; Singerling, M.; van Wijk, D.; Bor, A.; Aukema-Wouda, Z.; Hendriks-van Woerden, M.; Kort, I.; Danse, I.; van der Knaap, M.; de Jong, C.; Temminck, M.; Schaefer, T.; van der Ven, N.; Drost, I.; Mulder, R.; de Vos, A.; de Hoop, M.; Post, G.; Wielandt, D.; Edorot, N.; de Castro, K.; Flotildes, M.; Mulingtapang, T.; Vasquez, S.; Facundo, S.; Peralta, M.; Jose, M.; Bandiez, J.; Sulit, P.; Joaquin, F.; Arbis, M. G.; Silva, C.; Delgado, D.; de Leon, R.; Maglasang, P.; Sian, A.; Alagban, C.; Alcorano, J.; Marcelo, M. J.; Dela Pena, C.; Hyra, I.; Malkiewicz, B.; Mosakowska, K.; Cana, I.; Dobrin, I.; Lautaru, A.; Manescu, G.; Samoila, N.; Lacatus, M.; Apostoie, A.; Prunoiu, M.; Tilinca, M.; Budeanu, A.; Nedelcu, C.; Dumitrache, N.; Boeru, L.; Zhuravleva, E.; Gundova, M.; Hoffmannova, J.; Svitkova, M.; Pekarova, T.; Ujacka, K.; Zsoriova, T.; Kubincova, K.; Jankovicova, Z.; Talliard, C.; Tyumbu, N.; Mngoma, N.; Kannemeyer, M.; Mostert, J.; Page, A.; Krahenbuhl, C.; Tredoux, C.; Hendricks, L.; Oliver, S.; Le Grange, M.; Naidoo, V.; Bae, Y.; Kim, H.; Lee, J.; Yu, N.; An, S.; Kim, E.; Yang, K.; Woo, J.; Kim, S.; Rasck, J.; Smetana, S.; Ajax, K.; Bylander, L.; Lindberg, A.; Dellborg, H.; Hultsberg-Olsson, G.; Harsmar, K.; Knutsson, A.; Håkansson, L.; Kåveryd-Holmström, M.; Lundmark, L. M.; Norrfors, B.; Löf, P.; Skoglund, K.; Torgersruud, M.; Johansson, K.; Mattsson, A.; Quist, M.; Haglund, P.; Lundell, L.; Gunvasdotter, S.; Rangman, B.; Liu, R.; Shi, J.; Förstedt, G.; Nylund, L.; Welin-Berger, B.; Nilsson, O.; Garcia-Värlid, A.; Forlenza, R.; Kaminska, K.; Nagorna, T.; Cottam, V.; Harper, R.; Gilchrist, M.; Musanhu, R.; Mackin, A.; Turner, A.; Willetts, S.; Cadd, A.; Evans, J.; Young, G.; Sevillano, A.; Brodie, K.; Eccles, A.; Kelly, S.; Doughty, A.; Gray, J.; Gibson, M.; Finlayson, M.; Domingo, D.; Brazee, L.; Renaud, K.; Doman, A.; Meyer, R.; Beatty, J.; Morgan, T.; Rodas, E.; Campbell, D.; Mcquarrie, M.; Battistelli, E.; Eisenbraun, P.; Farley, R.; Park, H.; Dwyer, J.; Adams, K.; Schneider, W.; Barbour, C.; Whyne, E.; Budzinski, S.; Craig, M.; Gilley Elmore, J.; Scott, D.; Bellini, S.; Pepper, M.; Gunderson, K.; Stipek, I.; Schwarz, L.; Watkins, K.; Moore, V.; Palao, A.; Keane-Richmond, P.; Franklin, L.; Ward, L.; Kostedt, G.; Bailey, S.; Hollenweger, L.; Solomon, A.; Johnson, D.; Gloer, K.; Meyer, M.; Boleyn, M.; Nieters, D.; Humphrey, K.; Bohn, A.; Mueller, G.; Mckenzie, H.; Edwards, T.; Velky, J.; Cole, C.; Diederick, M.; Burg, S.; Coulson, T.; Karunaratne, K.; Gunasekera, R.; Cook, S.; Fisher, S.; Garrison, K.; Passey, L.; Kuykendall, K.; Luck, K.; Ramia, L.; Joan, H.; Reynoso, F.; Farley, M.; Shuman, S.; Santana-Fernandes, E.; Ventimiglia, A.; Steele, V.; Gers, L.; Brown, P.; Wilson, J.; Freebersyser, J.; Reno, M.; Buettner, N.; McGovern, M.; Hubbard, T.; Elmore, H.; Payne, D.; Mccann, M.; Decker, S.; Sharp, A.; Forgey, E.; Broussard, E.; Juett, U.; Siddiqui, A.

    2017-01-01

    We evaluated whether rivaroxaban alone or in combination with aspirin would be more effective than aspirin alone for secondary cardiovascular prevention. In this double-blind trial, we randomly assigned 27,395 participants with stable atherosclerotic vascular disease to receive rivaroxaban (2.5 mg

  4. Cardiovascular evaluation of middle-aged/ senior individuals engaged in leisure-time sport activities: position stand from the sections of exercise physiology and sports cardiology of the European Association of Cardiovascular Prevention and Rehabilitation.

    Science.gov (United States)

    Borjesson, Mats; Urhausen, Alex; Kouidi, Evangelia; Dugmore, Dorian; Sharma, Sanjay; Halle, Martin; Heidbüchel, Hein; Björnstad, Hans Halvor; Gielen, Stephan; Mezzani, Alessandro; Corrado, Domenico; Pelliccia, Antonio; Vanhees, Luc

    2011-06-01

    Regular aerobic exercise at moderate intensities and an increased physical fitness are associated with a reduced risk of fatal and nonfatal coronary events in middle-aged individuals. In contrast, moderate and vigorous physical exertion is associated with an increased risk for cardiac events, including sudden cardiac death in individuals harbouring cardiovascular disease. The risk-benefit ratio may differ in relation to the individual’s age, fitness level, and presence of cardiovascular disease; sedentary individuals with underlying coronary artery disease are at greatest risk. The intention of the present position stand of the European Association of Cardiovascular Prevention and Rehabilitation is to encourage individuals to participate in regular physical activity and derive the benefits of physical exercise while minimizing the risk of cardiovascular adverse events. Therefore, the aim is to establish the most practical method of cardiovascular evaluation in middle-age/senior individuals, who are contemplating exercise or who are already engaged in nonprofessional competitive or recreational leisure sporting activity. These recommendations rely on existing scientific evidence, and in the absence of such, on expert consensus. The methodology of how middle-aged and older individuals should be evaluated appropriately before engaging in regular physical activity is both complex and controversial. On practical grounds the consensus panel recommend that such evaluation should vary according to the individual’s cardiac risk profile and the intended level of physical activity. Self assessment of the habitual physical activity level and of the risk factors, are recommended for screening of large populations. Individuals deemed to be at risk require further evaluation by a qualified physician. In senior/adult individuals with an increased risk for coronary events, maximal exercise testing (and possibly further evaluations) is advocated. Hopefully, the recommendations

  5. Relations of GlycA and lipoprotein particle subspecies with cardiovascular events and mortality: A post hoc analysis of the AIM-HIGH trial.

    Science.gov (United States)

    Otvos, James D; Guyton, John R; Connelly, Margery A; Akapame, Sydney; Bittner, Vera; Kopecky, Steven L; Lacy, Megan; Marcovina, Santica M; Muhlestein, Joseph B; Boden, William E

    The Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides and Impact on Global Health Outcomes trial showed no incremental benefit of extended-release niacin (ERN) therapy added to simvastatin in subjects with cardiovascular disease (CVD). To examine the effects of ERN treatment on lipoprotein particles and GlycA, a new marker of systemic inflammation, and their relations with incident CVD events including mortality. GlycA and very low-density lipoprotein, low-density lipoprotein (LDL), and high-density lipoprotein (HDL) particle subclasses were quantified by nuclear magnetic resonance spectroscopy using available stored baseline (n = 2754) and 1-year in-trial (n = 2581) samples. Associations with CVD events and all-cause mortality were assessed using multivariable Cox proportional hazards regression adjusted for age, sex, diabetes, treatment assignment, and lipoproteins. Compared to placebo, ERN treatment lowered very low-density lipoprotein and LDL and increased HDL particle concentrations, increased LDL and HDL particle sizes (all P < .0001), but did not affect GlycA. Baseline and in-trial GlycA levels were associated with increased risk of CVD events: hazard ratio (HR) per SD increment, 1.17 (95% confidence interval [CI], 1.06-1.28) and 1.13 (1.02-1.26), respectively. However, none of the lipoprotein particle classes or subclasses was associated with incident CVD. By contrast, all-cause mortality was significantly associated with both GlycA (baseline HR: 1.46 [1.22-1.75]; in-trial HR: 1.41 [1.24-1.60]) and low levels of small HDL particles (baseline HR: 0.69 [0.56-0.86]; in-trial HR: 0.69 [0.56-0.86]). This Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides and Impact on Global Health Outcomes trial post hoc substudy indicates that inflammation, as indexed by GlycA, is unaffected by ERN treatment but is significantly associated with the residual risk of CVD and death in patients treated to low

  6. Cardiovascular evaluation of middle-aged individuals engaged in high-intensity sport activities: implications for workload, yield and economic costs.

    Science.gov (United States)

    Menafoglio, Andrea; Di Valentino, Marcello; Porretta, Alessandra Pia; Foglia, Pietro; Segatto, Jeanne-Marie; Siragusa, Patrick; Pezzoli, Reto; Maggi, Mattia; Romano, Gian Antonio; Moschovitis, Giorgio; Gallino, Augusto

    2015-06-01

    The European Association of Cardiovascular Prevention and Rehabilitation (EACPR) recommends cardiovascular evaluation of middle-aged individuals engaged in sport activities. However, very few data exist concerning the impact of such position stand. We assessed the implications on workload, yield and economic costs of this preventive strategy. Individuals aged 35-65 years engaged in high-intensity sports were examined following the EACPR protocol. Athletes with abnormal findings or considered at high-cardiovascular risk underwent additional examinations. The costs of the overall evaluation until diagnosis were calculated according to Swiss medical rates. 785 athletes (73% males, 46.8±7.3 years) were enrolled over a 13-month period. Among them, 14.3% required additional examinations: 5.1% because of abnormal ECG, 4.7% due to physical examination, 4.1% because of high-cardiovascular risk and 1.6% due to medical history. A new cardiovascular abnormality was established in 2.8% of athletes, severe hypercholesterolaemia in 1% and type 2 diabetes in 0.1%. Three (0.4%) athletes were considered ineligible for high-intensity sports, all of them discovered through an abnormal ECG. No athlete was diagnosed with significant coronary artery disease on the basis of a high-risk profile or an exercise ECG. The cost was US$199 per athlete and US$5052 per new finding. Cardiovascular evaluation of middle-aged athletes detected a new cardiovascular abnormality in about 3% of participants and a high-cardiovascular risk profile in about 4%. Some of these warranted exclusion of the athlete from high-intensity sport. The overall evaluation seems to be feasible at reasonable costs. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  7. Healthcare Policy Statement on the Utility of Coronary Computed Tomography for Evaluation of Cardiovascular Conditions and Preventive Healthcare: From the Health Policy Working Group of the Society of Cardiovascular Computed Tomography.

    Science.gov (United States)

    Slim, Ahmad M; Jerome, Scott; Blankstein, Ron; Weigold, Wm Guy; Patel, Amit R; Kalra, Dinesh K; Miller, Ryan; Branch, Kelley; Rabbat, Mark G; Hecht, Harvey; Nicol, Edward D; Villines, Todd C; Shaw, Leslee J

    The rising cost of healthcare is prompting numerous policy and advocacy discussions regarding strategies for constraining growth and creating a more efficient and effective healthcare system. Cardiovascular imaging is central to the care of patients at risk of, and living with, heart disease. Estimates are that utilization of cardiovascular imaging exceeds 20 million studies per year. The Society of Cardiovascular CT (SCCT), alongside Rush University Medical Center, and in collaboration with government agencies, regional payers, and industry healthcare experts met in November 2016 in Chicago, IL to evaluate obstacles and hurdles facing the cardiovascular imaging community and how they can contribute to efficacy while maintaining or even improving outcomes and quality. The summit incorporated inputs from payers, providers, and patients' perspectives, providing a platform for all voices to be heard, allowing for a constructive dialogue with potential solutions moving forward. This article outlines the proceedings from the summit, with a detailed review of past hurdles, current status, and potential solutions as we move forward in an ever-changing healthcare landscape. Copyright © 2017 Society of Cardiovascular Computed Tomography. All rights reserved.

  8. Design of a RCT evaluating the (cost- effectiveness of a lifestyle intervention for male construction workers at risk for cardiovascular disease: The Health under Construction study

    Directory of Open Access Journals (Sweden)

    van der Beek Allard J

    2008-01-01

    Full Text Available Abstract Background Of all workers in Dutch construction industry, 20% has an elevated risk of cardiovascular disease (CVD. A major risk factor for CVD risk is an unhealthy lifestyle. The aim of our study is to design a lifestyle intervention for construction workers with an elevated CVD risk, and to evaluate its (cost- effectiveness. Methods/Design In a RCT, 692 participants will be randomised to either the control or the intervention group. The control group will receive usual care. For the intervention group, a lifestyle intervention has been designed based on interviews and current literature. The intervention will last 6 months and will comprise 3 face-to-face and 4 telephone contacts, consisting of individual counselling aimed at increasing daily physical activity (PA and improving dietary behaviour, and/or smoking cessation. Counselling will take place at the Occupational Health Service (OHS, and will be done according to motivational interviewing (MI. Additional written information about healthy lifestyle will also be provided to those in the intervention group. At baseline, after 6 and after 12 months, measurements will take place. Primary outcome variables will be the lifestyle behaviours of concern, i.e. daily PA, dietary intake, and smoking status. Secondary outcome variables will be body mass index (BMI, systolic and diastolic blood pressure, total and HDL blood cholesterol, Hba1c and cardio-respiratory fitness (CRF. Sickness absenteeism and cost-effectiveness will be assessed as well. Multilevel analysis will be performed to compare all outcome measures between the intervention group and the control group. Discussion By improving lifestyle, CVD risk may be lowered, yielding benefits for both employee and employer. If proven effective, this lifestyle intervention will be implemented on a larger scale within the Occupational Health Services in construction industry. Trial registration Current Controlled Trials ISRCTN60545588

  9. Evaluation of effectiveness of sojourn in a health center of miners with cardiovascular pathology and residual manifestation of craniocerebral trauma

    Energy Technology Data Exchange (ETDEWEB)

    Davydova, N.N.; Nirenburg, K.G.; Kokorina, N.P.; Dyatlova, L.A.; Anikin, B.S.; Pokhlenko, V.B.; Belyaeva, N.G. (Meditsinskii Institut, Kemerovo (USSR))

    1989-02-01

    Evaluates effectiveness of the sojourn in a health center using standard methods of treatment and diet therapy of underground miners of the Kuzbass with early forms of arterial hypertension and manifestations of craniocerebral trauma. Miners were divided into three groups: (1) with hypertension; (2) with neuro-circulatory dystonia; and (3) with craniocerebral trauma. During 24 days at health center, groups 1 and 2 received sedatives, hypertensive medicines and physiotherapy, group 3 biostimulators and dehydrogenating preparations. Changes in conditions of patients were observed. Using the mathematical approach of Markov chains and the method of discrimination of samples to evaluate changes in arterial pressure, stroke volume of blood, pulse, latent period of visual-motor reactions, stability of understanding, and other tests of physiologic status of miners before and after treatment, investigators concluded that a stay in a health center is effective for miners suffering from cardiovascular pathology and mild cerebrocranil trauma under 40 years of age and with an underground work period of less than 10 years. For underground miners suffering cardiovascular pathology and cerebral trauma over 40 years of age and more than 10 years working underground, treatment in a health center at least twice a year is necessary. 5 refs.

  10. Advanced technologies of cardiovascular nuclear medicine and their evaluation in clinical practice

    International Nuclear Information System (INIS)

    Murata, Hajime; Iio, Masahiro; Toyama, Hinako.

    1981-01-01

    Currently available advanced methods of cardiovascular nuclear medicine for the diagnosis of ischemic heart disease were studied. The methods included the multigate method by a large capacity gamma camera-computer (128 KW memory with multilayer disc) system which made it possible to acquire the data of either the first pass study or the equilibrium study in ''image mode''. Analyzed data were displayed on a color CRT using our moving image system (MIS) and dynamic image thus obtained serve to help for the high sensitive observation of the regional wall motion as well as the global function of the ventricles. Myocardial tomography by a 7 pinhole collimator designed by us was also reported. The myocardial tomogram obtained was proven to show more sensitivity than two dimensional myocardial scan by the conventional collimator to detect smaller lesion and the lesions at the inferior or posterior wall of the left ventricle. The cardiovascular nuclear medicine with recent advanced technologies was thought to be sensitive and useful method for the diagnosis of the ventricular performance and the myocardial ischemia. (author)

  11. The Effect of Dietary Supplementation of Green Tea Catechins on Cardiovascular Disease Risk Markers in Humans: A Systematic Review of Clinical Trials

    Directory of Open Access Journals (Sweden)

    Sarah O. Lau

    2016-06-01

    Full Text Available Green tea catechins (GTCs are secondary plant metabolites that have been associated with health benefits in human trials. As such, they have the potential to reduce cardiovascular disease (CVD risk; however, results are not consistent. This systematic review of the published data assessed the putative effect of GTCs supplementation on anthropometric, blood pressure, and biochemical measures associated with CVD risk. It was conducted in accordance with the preferred reporting items for systematic reviews and meta-analyses (PRISMA guidelines exploring four major electronic databases (MEDLINE, Cochrane Library, Web of Science, and Scopus. Studies were included if they were published in peer-reviewed journals in English from 1990 until October 2015, and were human double-blind randomized and placebo-controlled trials (RCTs. From 122,428 articles initially identified, after two levels of screening, seven studies met the inclusion criteria. The review revealed consistent and significant (p ≤ 0.05 reductions in body mass index (BMI, blood pressure and plasma lipids; however, this effect would have been less if between-group effects had been considered. The current evidence base also has considerable methodological limitations due to suboptimal statistical methods used in data analyses. Future research efforts must aim to rectify this paucity of evidence with well-designed and well-reported prospective studies.

  12. Implementation of a comprehensive intervention for patients at high risk of cardiovascular disease in rural China: A pragmatic cluster randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Xiaolin Wei

    Full Text Available This study aims to assess whether a standard intervention package of cardiovascular disease (CVD care was being delivered effectively, and if it was associated with improved lifestyle and biomedical indicators.In rural China, we implemented a pragmatic cluster randomized controlled trial for 12 months, randomized at the township hospital level, and compared with usual care. Intervention case management guideline, training and performance monitoring meeting and patient support activities were designed to fit within the job description of family doctors in the township hospitals and comprised: 1 prescription of a standardised package of medicines targeted at those with hypertension or diabetes; 2 advice about specific lifestyle interventions; and 3 advice about medication adherence. Participants were 50-74 years old, had hypertension and CVD risk scores >20% or diabetes, but were excluded if a history of severe CVD events. We also randomly selected 100 participants from six selected clusters per arm as a panel to collect intermediate biomedical indicators over time.A total of 28,130 participants, in 33 intervention and 34 control township hospitals, were recruited. Compared with the control arm, participants in the intervention arm had substantially improved prescribing rates of anti-hypertensives, statins and aspirin (P0.05.Implementation of the package by family doctors was feasible and improved prescribing and some lifestyle changes. Additional measures such as reducing medication costs and patient education are required.Current Controlled Trials ISRCTN58988083.

  13. Evaluating the design and reporting of pragmatic trials in osteoarthritis research.

    Science.gov (United States)

    Ali, Shabana Amanda; Kloseck, Marita; Lee, Karen; Walsh, Kathleen Ellen; MacDermid, Joy C; Fitzsimmons, Deborah

    2018-01-01

    Among the challenges in health research is translating interventions from controlled experimental settings to clinical and community settings where chronic disease is managed daily. Pragmatic trials offer a method for testing interventions in real-world settings but are seldom used in OA research. The aim of this study was to evaluate the literature on pragmatic trials in OA research up to August 2016 in order to identify strengths and weaknesses in the design and reporting of these trials. We used established guidelines to assess the degree to which 61 OA studies complied with pragmatic trial design and reporting. We assessed design according to the pragmatic-explanatory continuum indicator summary and reporting according to the pragmatic trials extension of the CONsolidated Standards of Reporting Trials guidelines. None of the pragmatic trials met all 11 criteria evaluated and most of the trials met between 5 and 8 of the criteria. Criteria most often unmet pertained to practitioner expertise (by requiring specialists) and criteria most often met pertained to primary outcome analysis (by using intention-to-treat analysis). Our results suggest a lack of highly pragmatic trials in OA research. We identify this as a point of opportunity to improve research translation, since optimizing the design and reporting of pragmatic trials can facilitate implementation of evidence-based interventions for OA care. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

  14. Cardiovascular Actions and Clinical Outcomes With Glucagon-Like Peptide-1 Receptor Agonists and Dipeptidyl Peptidase-4 Inhibitors.

    Science.gov (United States)

    Nauck, Michael A; Meier, Juris J; Cavender, Matthew A; Abd El Aziz, Mirna; Drucker, Daniel J

    2017-08-29

    Potentiation of glucagon-like peptide-1 (GLP-1) action through selective GLP-1 receptor (GLP-1R) agonism or by prevention of enzymatic degradation by inhibition of dipeptidyl peptidase-4 (DPP-4) promotes glycemic reduction for the treatment of type 2 diabetes mellitus by glucose-dependent control of insulin and glucagon secretion. GLP-1R agonists also decelerate gastric emptying, reduce body weight by reduction of food intake and lower circulating lipoproteins, inflammation, and systolic blood pressure. Preclinical studies demonstrate that both GLP-1R agonists and DPP-4 inhibitors exhibit cardioprotective actions in animal models of myocardial ischemia and ventricular dysfunction through incompletely characterized mechanisms. The results of cardiovascular outcome trials in human subjects with type 2 diabetes mellitus and increased cardiovascular risk have demonstrated a cardiovascular benefit (significant reduction in time to first major adverse cardiovascular event) with the GLP-1R agonists liraglutide (LEADER trial [Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Ourcome Results], -13%) and semaglutide (SUSTAIN-6 trial [Trial to Evaluate Cardiovascular and Other Long-term Outcomes with Semaglutide], -24%). In contrast, cardiovascular outcome trials examining the safety of the shorter-acting GLP-1R agonist lixisenatide (ELIXA trial [Evaluation of Lixisenatide in Acute Coronary Syndrom]) and the DPP-4 inhibitors saxagliptin (SAVOR-TIMI 53 trial [Saxagliptin Assessment of Vascular Outcomes Recorded in Patients With Diabetes Mellitus-Thrombolysis in Myocardial Infarction 53]), alogliptin (EXAMINE trial [Examination of Cardiovascular Outcomes With Alogliptin Versus Standard of Care in Patients With Type 2 Diabetes Mellitus and Acute Coronary Syndrome]), and sitagliptin (TECOS [Trial Evaluating Cardiovascular Outcomes With Sitagliptin]) found that these agents neither increased nor decreased cardiovascular events. Here we review the

  15. Evaluation of risk factors for cardiovascular diseases among Saudi diabetic patients attending primary health care service.

    Science.gov (United States)

    Ahmed, Almoutaz Alkhier; Alsharief, Emad; Alsharief, Ali

    2013-01-01

    Cardiovascular disease is currently the primary cause of morbidity and mortality in patients with diabetes. For each risk factor present, the risk of cardiovascular death is about three times greater in people with diabetes than people without diabetes. To determine the risk factors for cardiovascular disease among patients with type 2 diabetes. To stratify the patients into risk categories to develop coronary arteries disease (CAD) based on the British Joint Societies risk chart. To assess the awareness and implementation of the risk assessment charts by primary care physicians Cross sectional study was designed. Sixty six (66 patients) diabetic patients were selected randomly by simple selection, from them 29 were males and 37 were females. Patients' medical records were reviewed. The following parameters were detected; blood pressure, lipid profile, weight, height, smoking and degree of glycemic control. A questionnaire was designed and distributed to randomly selected physicians working in primary health care assessed their awareness and implementation of risk assessment charts was done. Uncontrolled diabetes was found to be the common risk factor followed by uncontrolled lipid profile, obesity, uncontrolled systolic blood pressure and smoking. Seven percent (7%) of male group felled in highest risk group in comparison with 1% in female group (Prisk group in comparison with 90% in female group (Prisk group in comparison with 9% in female group (Prisk class differed between male and female group. Forty one physicians were contacted and received the questionnaire. Twenty nine (70.7%) physicians were responded to the questionnaire. Twenty two (22) informed that they were aware about risk assessment score systems. Fourteen (14) physicians informed that they were aware about the BJSs charts but only two informed that they had used it to assess their patients. Clustering of multi risk factors is a serious event which may raise the risk category of diabetic patients

  16. Cardiovascular safety of empagliflozin in patients with type 2 diabetes: a meta-analysis of data from randomized placebo-controlled trials.

    Science.gov (United States)

    Salsali, A; Kim, G; Woerle, H J; Broedl, U C; Hantel, S

    2016-10-01

    To assess the effect of empagliflozin on cardiovascular (CV) risk in patients with type 2 diabetes (T2DM) through a meta-analysis of data from eight placebo-controlled trials. Data were analysed from eight randomized placebo-controlled trials undertaken to investigate the efficacy and safety of empagliflozin 10 and 25 mg once daily in patients with T2DM, comprising patients at low/medium and high CV risk. Suspected CV events were prospectively adjudicated. The empagliflozin 10 and 25 mg groups were pooled for the primary analysis. The primary endpoint was a composite of CV death, non-fatal myocardial infarction (MI), non-fatal stroke and hospitalization for unstable angina [4-point major adverse CV events (MACE)]. The secondary endpoint was a composite of CV death, non-fatal MI and non-fatal stroke (3-point MACE). Risk estimates were calculated using Cox regression analysis. A total of 3835 patients received placebo and 7457 received empagliflozin. Total exposure was 7448.3 years for placebo and 15482.1 years for empagliflozin. Four-point MACE occurred in 365 (9.5%) patients receiving placebo and 635 (8.5%) patients receiving empagliflozin [hazard ratio for empagliflozin vs. placebo 0.86 (95% CI 0.76, 0.98)]. Three-point MACE occurred in 307 (8.0%) patients receiving placebo and 522 (7.0%) patients receiving empagliflozin [hazard ratio for empagliflozin vs. placebo 0.84 (95% CI 0.73, 0.96)]. In a meta-analysis of data from eight randomized trials involving 11 292 patients with T2DM at low/medium or high CV risk, empagliflozin was associated with a reduced risk of 4-point MACE and 3-point MACE compared with placebo. © 2016 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

  17. Kā-HOLO Project: a protocol for a randomized controlled trial of a native cultural dance program for cardiovascular disease prevention in Native Hawaiians.

    Science.gov (United States)

    Kaholokula, Joseph Keawe'aimoku; Look, Mele A; Wills, Thomas A; de Silva, Māpuana; Mabellos, Tricia; Seto, Todd B; Ahn, Hyeong Jun; Sinclair, Ka'imi A; Buchwald, Dedra

    2017-04-17

    As a major risk factor for cardiovascular and cerebrovascular disease (CVD), hypertension affects 33% of U.S. adults. Relative to other US races and ethnicities, Native Hawaiians have a high prevalence of hypertension and are 3 to 4 times more likely to have CVD. Effective, culturally-relevant interventions are needed to address CVD risk in this population. Investigators of the Kā-HOLO Project developed a study design to test the efficacy of an intervention that uses hula, a traditional Hawaiian dance, to increase physical activity and reduce CVD risk. A 2-arm randomized controlled trial with a wait-list control design will be implemented to test a 6-month intervention based on hula to manage blood pressure and reduce CVD risk in 250 adult Native Hawaiians with diagnosed hypertension. Half of the sample will be randomized to each arm, stratified across multiple study sites. Primary outcomes are reduction in systolic blood pressure and improvement in CVD risk as measured by the Framingham Risk Score. Other psychosocial and sociocultural measures will be included to determine mediators of intervention effects on primary outcomes. Assessments will be conducted at baseline, 3 months, and 6 months for all participants, and at 12 months for intervention participants only. This trial will elucidate the efficacy of a novel hypertension management program designed to reduce CVD risk in an indigenous population by using a cultural dance form as its physical activity component. The results of this culturally-based intervention will have implications for other indigenous populations globally and will offer a sustainable, culturally-relevant means of addressing CVD disparities. ClinicalTrials.gov: NCT02620709 , registration date November 23, 2015.

  18. Mediterranean diet improves high-density lipoprotein function in high-cardiovascular-risk Individuals: a randomized controlled trial

    OpenAIRE

    Hernáez , Álvaro; Castañer, Olga; Elosua, Roberto; Pintó Sala, Xavier; Estruch, Ramón; Salas Salvadó, Jordi; Corella, Dolores; Arós, Fernando; Serra Majem, Lluís; Fiol, Miquel; Ortega Calvo, Manuel; Ros, Emilio; Martínez-González, Miguel Ángel; Torre Fornell, Rafael de la; López-Sabater, M. Carmen

    2017-01-01

    BACKGROUND: The biological functions of high-density lipoproteins (HDLs) contribute to explaining the cardioprotective role of the lipoprotein beyond quantitative HDL cholesterol levels. A few small-scale interventions with a single antioxidant have improved some HDL functions. However, to date, no long-term, large-scale, randomized controlled trial has been conducted to assess the effects of an antioxidant-rich dietary pattern (such as a traditional Mediterranean diet [TMD]) on HDL function ...

  19. Pharmacogenetic meta-analysis of baseline risk factors, pharmacodynamic, efficacy and tolerability endpoints from two large global cardiovascular outcomes trials for darapladib.

    Directory of Open Access Journals (Sweden)

    Astrid Yeo

    Full Text Available Darapladib, a lipoprotein-associated phospholipase A2 (Lp-PLA2 inhibitor, failed to demonstrate efficacy for the primary endpoints in two large phase III cardiovascular outcomes trials, one in stable coronary heart disease patients (STABILITY and one in acute coronary syndrome (SOLID-TIMI 52. No major safety signals were observed but tolerability issues of diarrhea and odor were common (up to 13%. We hypothesized that genetic variants associated with Lp-PLA2 activity may influence efficacy and tolerability and therefore performed a comprehensive pharmacogenetic analysis of both trials. We genotyped patients within the STABILITY and SOLID-TIMI 52 trials who provided a DNA sample and consent (n = 13,577 and 10,404 respectively, representing 86% and 82% of the trial participants using genome-wide arrays with exome content and performed imputation using a 1000 Genomes reference panel. We investigated baseline and change from baseline in Lp-PLA2 activity, two efficacy endpoints (major coronary events and myocardial infarction as well as tolerability parameters at genome-wide and candidate gene level using a meta-analytic approach. We replicated associations of published loci on baseline Lp-PLA2 activity (APOE, CELSR2, LPA, PLA2G7, LDLR and SCARB1 and identified three novel loci (TOMM5, FRMD5 and LPL using the GWAS-significance threshold P≤5E-08. Review of the PLA2G7 gene (encoding Lp-PLA2 within these datasets identified V279F null allele carriers as well as three other rare exonic null alleles within various ethnic groups, however none of these variants nor any other loci associated with Lp-PLA2 activity at baseline were associated with any of the drug response endpoints. The analysis of darapladib efficacy endpoints, despite low power, identified six low frequency loci with main genotype effect (though with borderline imputation scores and one common locus (minor allele frequency 0.24 with genotype by treatment interaction effect passing the GWAS

  20. Evaluation of pharmacodynamic properties and safety of Cinnamomum zeylanicum (Ceylon cinnamon) in healthy adults: a phase I clinical trial.

    Science.gov (United States)

    Ranasinghe, Priyanga; Jayawardena, Ranil; Pigera, Shehani; Wathurapatha, Wasundara Sevwandi; Weeratunga, Hasitha Dhananjaya; Premakumara, G A Sirimal; Katulanda, Prasad; Constantine, Godwin Roger; Galappaththy, Priyadarshani

    2017-12-28

    Cinnamon is considered as a treatment for many ailments in native medicine. Evidence suggests that Cinnamomum zeylanicum (CZ) has anti-microbial, anti-parasitic, anti-oxidant, blood glucose lowering properties and beneficial cardiovascular effects. The present study aims to evaluate Pharmacodynamic properties and safety of CZ in healthy adults using a Phase I Clinical Trial. This phase I clinical trial was conducted at the Department of Pharmacology, Faculty of Medicine, University of Colombo, Sri Lanka. Thirty healthy adults were recruited for the study, conducted for a period of 3 months, with the dose of CZ (water extract) increased at monthly intervals (85 mg, 250 mg and 500 mg). Data collection was carried out at baseline and during each monthly follow up visit. Anthropometric, clinical and biochemical assessments were done at baseline and during follow up. Adverse effects and drug compliance was also evaluated. Twenty eight subjects completed the three months follow up. Mean age was 38.8 ± 10.4 years and 50% were males. There were no significant changes in the anthropometric parameters during the three months follow up. Both systolic and diastolic blood pressure reduced significant during the 1st month and this reduction was sustained throughout follow up. Full blood count, renal function tests, liver function tests, fasting blood glucose, HDL-c, VLDL-d and triglycerides remained within the normal range without any significant alteration during the 3 months. A significant reduction in the TC (p < 0.05) and LDL-c (p < 0.001) was noted at the end of the 3 months follow up period. There were no serious adverse effects (including hypersensitivity) noted. In two participants dyspepsia necessitated the discontinuation of study participation. Drug compliance was between 85 and 95% during the study period. This is the first phase I clinical trial in health adults evaluating efficacy and safety of CZ. Our results demonstrate no significant side

  1. BLIND TRIALS EVALUATING IN VITRO INFECTIVITY OF CRYPTOSPORIDIUM PARVUM OOCYSTS USING CELL CULTURE IMMUNOFLUORESCENCE

    Science.gov (United States)

    An optimized cell culture-immunofluorescence (IFA) procedure, using the HCT-8 cell line, was evaluated in 'blind' trials to determine the sensitivity and reproducibility for measuring infectivity of flow cytometry prepared inocula of C. parvum oocysts. In separate trials, suspens...

  2. Evaluation of the Utility of a Discrete-Trial Functional Analysis in Early Intervention Classrooms

    Science.gov (United States)

    Kodak, Tiffany; Fisher, Wayne W.; Paden, Amber; Dickes, Nitasha

    2013-01-01

    We evaluated a discrete-trial functional analysis implemented by regular classroom staff in a classroom setting. The results suggest that the discrete-trial functional analysis identified a social function for each participant and may require fewer staff than standard functional analysis procedures.

  3. Cardiovascular and renal effects of carperitide and nesiritide in cardiovascular surgery patients: a systematic review and meta-analysis.

    Science.gov (United States)

    Mitaka, Chieko; Kudo, Toshifumi; Haraguchi, Go; Tomita, Makoto

    2011-01-01

    Acute kidney injury (AKI) following cardiovascular surgery is a common disease process and is associated with both morbidity and mortality. The aim of our study was to evaluate the cardiovascular and renal effects of an atrial natriuretic peptide (ANP, carperitide) and a B-type (or brain) natriuretic peptide (BNP, nesiritide) for preventing and treating AKI in cardiovascular surgery patients. Electronic databases, including PubMed, EMBASE and references from identified articles were used for a literature search. Data on the infusion of ANP or BNP in cardiovascular surgery patients was collected from fifteen randomized controlled trials and combined. The infusion of ANP or BNP increased the urine output and creatinine clearance or glomerular filtration rate, and reduced the use of diuretics and the serum creatinine levels. A meta-analysis showed that ANP infusion significantly decreased peak serum creatinine levels, incidence of arrhythmia and renal replacement therapy. The meta-analysis also showed that ANP or BNP infusion significantly decreased the length of ICU stay and hospital stay compared with controls. However, the combined data were insufficient to determine how ANP or BNP infusion during the perioperative period influences long-term outcome in cardiovascular surgery patients. The infusion of ANP or BNP may preserve postoperative renal function in cardiovascular surgery patients. A large, multicenter, prospective, randomized controlled trial will have to be performed to assess the therapeutic potential of ANP or BNP in preventing and treating AKI in the cardiovascular surgical setting.

  4. Colchicine for prevention of cardiovascular events.

    Science.gov (United States)

    Hemkens, Lars G; Ewald, Hannah; Gloy, Viktoria L; Arpagaus, Armon; Olu, Kelechi K; Nidorf, Mark; Glinz, Dominik; Nordmann, Alain J; Briel, Matthias

    2016-01-27

    Colchicine is an anti-inflammatory drug that is used for a wide range of inflammatory diseases. Cardiovascular disease also has an inflammatory component but the effects of colchicine on cardiovascular outcomes remain unclear. Previous safety analyses were restricted to specific patient populations. To evaluate potential cardiovascular benefits and harms of a continuous long-term treatment with colchicine in any population, and specifically in people with high cardiovascular risk. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, ClinicalTrials.gov, WHO International Clinical Trials Registry, citations of key papers, and study references in January 2015. We also contacted investigators to gain unpublished data. Randomised controlled trials (parallel-group or cluster design or first phases of cross-over studies) comparing colchicine over at least six months versus any control in any adult population. Primary outcomes were all-cause mortality, myocardial infarction, and adverse events. Secondary outcomes were cardiovascular mortality, stroke, heart failure, non-scheduled hospitalisations, and non-scheduled cardiovascular interventions. We conducted predefined subgroup analyses, in particular for participants with high cardiovascular risk. . We included 39 randomised parallel-group trials with 4992 participants. Colchicine had no effect on all-cause mortality (RR 0.94, 95% CI 0.82 to 1.09; participants = 4174; studies = 30; I² = 27%; moderate quality of evidence). There is uncertainty surrounding the effect of colchicine in reducing cardiovascular mortality (RR 0.34, 95% CI 0.09 to 1.21, I² = 9%; participants = 1132; studies = 7; moderate quality of evidence). Colchicine reduced the risk for total myocardial infarction (RR 0.20, 95% CI 0.07 to 0.57; participants = 652; studies = 2; moderate quality of evidence). There was no effect on total adverse events (RR 1.52, 95% CI 0.93 to 2.46; participants = 1313; studies = 11; I

  5. Evaluation of influenza prevention in the workplace using a personally controlled health record: randomized controlled trial.

    Science.gov (United States)

    Bourgeois, Florence T; Simons, William W; Olson, Karen; Brownstein, John S; Mandl, Kenneth D

    2008-03-14

    Personally controlled health records (PCHRs) are accessible over the Internet and allow individuals to maintain and manage a secure copy of their medical data. These records provide a new opportunity to provide customized health recommendations to individuals based on their record content. Health promotion programs using PCHRs can potentially be used in a variety of settings and target a large range of health issues. The aim was to assess the value of a PCHR in an employee health promotion program for improving knowledge, beliefs, and behavior around influenza prevention. We evaluated a PCHR-based employee health promotion program using a randomized controlled trial design. Employees at Hewlett Packard work sites who reported reliable Internet access and email use at least once every 2 days were recruited for participation. PCHRs were provided to all participants for survey administration, and tailored, targeted health messages on influenza illness and prevention were delivered to participants in the intervention group. Participants in the control group received messages addressing cardiovascular health and sun protection. The main outcome measure was improvement in knowledge, beliefs, and behavior around influenza prevention. Secondary outcomes were influenza vaccine rates among household members, the impact of cardiovascular health and sun protection messages on the control group, and the usability and utility of the PCHR-based program for employees. The intervention did not have a statistically significant effect on the influenza knowledge elements we assessed but did impact certain beliefs surrounding influenza. Participants in the intervention group were more likely to believe that the influenza vaccine was effective (OR = 5.6; 95% CI = 1.7-18.5), that there were actions they could take to prevent the flu (OR = 3.2; 95% CI = 1.1-9.2), and that the influenza vaccine was unlikely to cause a severe reaction (OR = 4.4; 95% CI = 1.3-15.3). Immunization rates did

  6. A critical evaluation of the clinical evidence for pomegranate preparations in the prevention and treatment of cardiovascular diseases.

    Science.gov (United States)

    Vlachojannis, Christian; Erne, Paul; Schoenenberger, Andreas W; Chrubasik-Hausmann, Sigrun

    2015-04-01

    This study attempts a critical evaluation of the clinical evidence behind the use of dietary pomegranate preparations in the prevention and treatment of cardiovascular diseases. A search of PubMed on August 10, 2014 identified 228 references, which yielded extractable data from 24 clinical studies of pomegranate preparations. Hand searching identified two further studies. The quality of the studies and evidence of effectiveness of pomegranate were assessed by an established set of conventional criteria. Overall, the study quality was poor. Even in the best studies, indications of benefit did not reach the conventional levels of statistical significance. The only study with a definitive design had a biochemical rather than a clinical endpoint: it showed the expected difference in blood concentrations of myeloperoxidase after a single dose of either pomegranate or placebo. Only 10 of the 26 studies provided HPLC data on the amounts of co-active ingredients in the preparations that were consumed by the subjects. If pomegranate has a role in the prevention and treatment of cardiovascular diseases, there is a pressing need for dose-finding and long-term confirmatory studies. The ultimate endpoint for definitive studies would be mortality, but reductions in blood pressure or demonstrable decreases in atherosclerotic plaques would be useful surrogates. Sample sizes for various assumptions are provided. Future studies need to prove the clinical benefit. Copyright © 2015 John Wiley & Sons, Ltd.

  7. An integrated general practice and pharmacy-based intervention to promote the use of appropriate preventive medications among individuals at high cardiovascular disease risk: protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Hayek, Adina; Joshi, Rohina; Usherwood, Tim; Webster, Ruth; Kaur, Baldeep; Saini, Bandana; Armour, Carol; Krass, Ines; Laba, Tracey-Lea; Reid, Christopher; Shiel, Louise; Hespe, Charlotte; Hersch, Fred; Jan, Stephen; Lo, Serigne; Peiris, David; Rodgers, Anthony; Patel, Anushka

    2016-09-23

    Cardiovascular diseases (CVD) are responsible for significant morbidity, premature mortality, and economic burden. Despite established evidence that supports the use of preventive medications among patients at high CVD risk, treatment gaps remain. Building on prior evidence and a theoretical framework, a complex intervention has been designed to address these gaps among high-risk, under-treated patients in the Australian primary care setting. This intervention comprises a general practice quality improvement tool incorporating clinical decision support and audit/feedback capabilities; availability of a range of CVD polypills (fixed-dose combinations of two blood pressure lowering agents, a statin ± aspirin) for prescription when appropriate; and access to a pharmacy-based program to support long-term medication adherence and lifestyle modification. Following a systematic development process, the intervention will be evaluated in a pragmatic cluster randomized controlled trial including 70 general practices for a median period of 18 months. The 35 general practices in the intervention group will work with a nominated partner pharmacy, whereas those in the control group will provide usual care without access to the intervention tools. The primary outcome is the proportion of patients at high CVD risk who were inadequately treated at baseline who achieve target blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) levels at the study end. The outcomes will be analyzed using data from electronic medical records, utilizing a validated extraction tool. Detailed process and economic evaluations will also be performed. The study intends to establish evidence about an intervention that combines technological innovation with team collaboration between patients, pharmacists, and general practitioners (GPs) for CVD prevention. Australian New Zealand Clinical Trials Registry ACTRN12616000233426.

  8. Effect of fish oil supplementation on graft patency and cardiovascular events among patients with new synthetic arteriovenous hemodialysis grafts: a randomized controlled trial.

    Science.gov (United States)

    Lok, Charmaine E; Moist, Louise; Hemmelgarn, Brenda R; Tonelli, Marcello; Vazquez, Miguel A; Dorval, Marc; Oliver, Matthew; Donnelly, Sandra; Allon, Michael; Stanley, Kenneth

    2012-05-02

    Synthetic arteriovenous grafts, an important option for hemodialysis vascular access, are prone to recurrent stenosis and thrombosis. Supplementation with fish oils has theoretical appeal for preventing these outcomes. To determine the effect of fish oil on synthetic hemodialysis graft patency and cardiovascular events. The Fish Oil Inhibition of Stenosis in Hemodialysis Grafts (FISH) study, a randomized, double-blind, controlled clinical trial conducted at 15 North American dialysis centers from November 2003 through December 2010 and enrolling 201 adults with stage 5 chronic kidney disease (50% women, 63% white, 53% with diabetes), with follow-up for 12 months after graft creation. Participants were randomly allocated to receive fish oil capsules (four 1-g capsules/d) or matching placebo on day 7 after graft creation. Proportion of participants experiencing graft thrombosis or radiological or surgical intervention during 12 months' follow-up. The risk of the primary outcome did not differ between fish oil and placebo recipients (48/99 [48%] vs 60/97 [62%], respectively; relative risk, 0.78 [95% CI, 0.60 to 1.03; P = .06]). However, the rate of graft failure was lower in the fish oil group (3.43 vs 5.95 per 1000 access-days; incidence rate ratio [IRR], 0.58 [95% CI, 0.44 to 0.75; P oil group, there were half as many thromboses (1.71 vs 3.41 per 1000 access-days; IRR, 0.50 [95% CI, 0.35 to 0.72; P oil ingestion did not decrease the proportion of grafts with loss of native patency within 12 months. Although fish oil improved some relevant secondary outcomes such as graft patency, rates of thrombosis, and interventions, other potential benefits on cardiovascular events require confirmation in future studies. isrctn.org Identifier: ISRCTN15838383.

  9. Comparison of treatment outcomes in patients with and without diabetes mellitus attending a multidisciplinary cardiovascular prevention programme (a retrospective analysis of the EUROACTION trial).

    Science.gov (United States)

    Ofori, Sandra N; Kotseva, Kornelia

    2015-02-24

    The objective was to compare the improvements in lifestyle and risk factor profiles in patients with and without diabetes mellitus (DM) in the intervention arm of EUROACTION study. This was a retrospective analysis of the intervention arm of EUROACTION trial. Primary outcome was proportions meeting the European targets for not smoking, diet, physical activity (PA), body mass index (BMI), waist circumference (WC), blood pressure (BP), total and low-density lipoprotein (LDL) cholesterol and cardio-protective drug use at one year. 179 and 777 coronary patients with and without DM, and 340 and 917 high-risk individuals (HRI) with and without DM, respectively were identified. The proportions of coronary patients achieving the lifestyle targets improved from the initial assessment (IA) except non-smoking, which reduced. At one year, significantly fewer patients with DM attained the targets for BMI (13.2% vs 31.3%, p = 0.002) and BP HRIs, fewer patients with DM achieved targets for oily fish intake (9.3% vs 11.9%, p = 0.043), physical activity (65.8% vs 75.8%, p = 0.011), and BMI (9.9% vs 28.1%, p = 0.022) at one year. While more patients with DM achieved the targets for total cholesterol (48.2% vs 22.9%, p < 0.001) and LDL (57.9% vs 30.7%, p < 0.001). Multidisciplinary intervention had a beneficial effect on several cardiovascular risk factors in both patients with and without DM. Poorer achievement of mostly lifestyle (and BP in coronary patients) targets among those with DM emphasises the need for more intensive lifestyle modification and BP management for the prevention of cardiovascular disease.

  10. Walking training at the heart rate of pain threshold improves cardiovascular function and autonomic regulation in intermittent claudication: A randomized controlled trial.

    Science.gov (United States)

    Chehuen, Marcel; Cucato, Gabriel G; Carvalho, Celso Ricardo F; Ritti-Dias, Raphael M; Wolosker, Nelson; Leicht, Anthony S; Forjaz, Cláudia Lúcia M

    2017-10-01

    This study investigated the effects of walking training (WT) on cardiovascular function and autonomic regulation in patents with intermittent claudication (IC). Randomized controlled trial. Forty-two male patients with IC (≥50years) were randomly allocated into two groups: control (CG, n=20, 30min of stretching exercises) and WT (WTG, n=22, 15 bouts of 2min of walking interpolated by 2min of upright rest-walking intensity was set at the heart rate of pain threshold). Both interventions were performed twice/week for 12 weeks. Walking capacity (maximal treadmill test), blood pressure (auscultatory), cardiac output (CO 2 rebreathing), heart rate (ECG), stroke volume, systemic vascular resistance, forearm and calf vascular resistance (plethysmography), and low (LF) and high frequency (HF) components of heart rate variability and spontaneous baroreflex sensitivity were measured at baseline and after 12 weeks of the study. WT increased total walking distance (+302±85m, p=0.001) and spontaneous baroreflex sensitivity (+2.13±1.07ms/mmHg, p=0.02). Additionally, at rest, WT decreased systolic and mean blood pressures (-10±3 and -5±2mmHg, p=0.001 and p=0.01, respectively), cardiac output (-0.37±0.24l/min, p=0.03), heart rate (-4±2bpm, p=0.001), forearm vascular resistance (-8.5±2.8U, p=0.02) and LF/HF (-1.24±0.99, p=0.001). No change was observed in the CG. In addition to increasing walking capacity, WT improved cardiovascular function and autonomic regulation in patients with IC. Copyright © 2017 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  11. Plasma Ceramides, Mediterranean Diet, and Incident Cardiovascular Disease in the PREDIMED Trial (Prevención con Dieta Mediterránea).

    Science.gov (United States)

    Wang, Dong D; Toledo, Estefanía; Hruby, Adela; Rosner, Bernard A; Willett, Walter C; Sun, Qi; Razquin, Cristina; Zheng, Yan; Ruiz-Canela, Miguel; Guasch-Ferré, Marta; Corella, Dolores; Gómez-Gracia, Enrique; Fiol, Miquel; Estruch, Ramón; Ros, Emilio; Lapetra, José; Fito, Montserrat; Aros, Fernando; Serra-Majem, Luis; Lee, Chih-Hao; Clish, Clary B; Liang, Liming; Salas-Salvadó, Jordi; Martínez-González, Miguel A; Hu, Frank B

    2017-05-23

    Although in vitro studies and investigations in animal models and small clinical populations have suggested that ceramides may represent an intermediate link between overnutrition and certain pathological mechanisms underlying cardiovascular disease (CVD), no prospective studies have investigated the association between plasma ceramides and risk of CVD. The study population consisted of 980 participants from the PREDIMED trial (Prevención con Dieta Mediterránea), including 230 incident cases of CVD and 787 randomly selected participants at baseline (including 37 overlapping cases) followed for ≤7.4 years. Participants were randomized to a Mediterranean diet supplemented with extra virgin olive oil, a Mediterranean diet supplemented with nuts, or a control diet. Plasma ceramide concentrations were measured on a liquid chromatography tandem mass spectrometry metabolomics platform. The primary outcome was a composite of nonfatal acute myocardial infarction, nonfatal stroke, or cardiovascular death. Hazard ratios were estimated with weighted Cox regression models using Barlow weights to account for the case-cohort design. The multivariable hazard ratios (HR) and 95% confidence intervals (CIs) comparing the extreme quartiles of plasma concentrations of C16:0, C22:0, C24:0, and C24:1 ceramides were 2.39 (1.49-3.83, P trend Mediterranean diet and control groups during the first year of follow-up. Our study documented a novel positive association between baseline plasma ceramide concentrations and incident CVD. In addition, a Mediterranean dietary intervention may mitigate potential deleterious effects of elevated plasma ceramide concentrations on CVD. URL: http://www.isrctn.com. Unique identifier: ISRCTN35739639. © 2017 American Heart Association, Inc.

  12. Evaluation of Kilifi epilepsy education programme: a randomized controlled trial.

    Science.gov (United States)

    Ibinda, Fredrick; Mbuba, Caroline K; Kariuki, Symon M; Chengo, Eddie; Ngugi, Anthony K; Odhiambo, Rachael; Lowe, Brett; Fegan, Greg; Carter, Julie A; Newton, Charles R

    2014-02-01

    The epilepsy treatment gap is largest in resource-poor countries. We evaluated the efficacy of a 1-day health education program in a rural area of Kenya. The primary outcome was adherence to antiepileptic drugs (AEDs) as measured by drug levels in the blood, and the secondary outcomes were seizure frequency and Kilifi Epilepsy Beliefs and Attitudes Scores (KEBAS). Seven hundred thirty-eight people with epilepsy (PWE) and their designated supporter were randomized to either the intervention (education) or nonintervention group. Data were collected at baseline and 1 year after the education intervention was administered to the intervention group. There were 581 PWE assessed at both time points. At the end of the study, 105 PWE from the intervention group and 86 from the nonintervention group gave blood samples, which were assayed for the most commonly used AEDs (phenobarbital, phenytoin, and carbamazepine). The proportions of PWE with detectable AED levels were determined using a standard blood assay method. The laboratory technicians conducting the assays were blinded to the randomization. Secondary outcomes were evaluated using questionnaires administered by trained field staff. Modified Poisson regression was used to investigate the factors associated with improved adherence (transition from nonoptimal AED level in blood at baseline to optimal levels at follow-up), reduced seizures, and improved KEBAS, which was done as a post hoc analysis. This trial is registered in ISRCTN register under ISRCTN35680481. There was no significant difference in adherence to AEDs based on detectable drug levels (odds ratio [OR] 1.46, 95% confidence interval [95% CI] 0.74-2.90, p = 0.28) or by self-reports (OR 1.00, 95% CI 0.71-1.40, p = 1.00) between the intervention and nonintervention group. The intervention group had significantly fewer beliefs about traditional causes of epilepsy, cultural treatment, and negative stereotypes than the nonintervention group. There was no

  13. New insights about vitamin d and cardiovascular disease: a narrative review.

    LENUS (Irish Health Repository)

    McGreevy, Cora

    2012-02-01

    The worsening worldwide trend toward nutritional insufficiency and the emerging knowledge of the nonhormonal actions of vitamin D and its metabolites have increased interest in the synthesis, metabolism, and action of vitamin D. Vitamin D deficiency has been linked with hypertension, myocardial infarction, and stroke, as well as other cardiovascular-related diseases, such as diabetes, congestive heart failure, peripheral vascular disease, atherosclerosis, and endothelial dysfunction. This review discusses the physiology and definition of vitamin D deficiency, evaluates the worldwide prevalence of vitamin D deficiency, and discusses recent evidence for the association between hypovitaminosis D and cardiovascular disease. Few randomized, controlled trials have evaluated the effect of vitamin D replacement on cardiovascular outcomes, and the results have been inconclusive or contradictory. Carefully designed randomized, controlled trials are essential to evaluate the role of vitamin D supplementation in reducing cardiovascular disease.

  14. Reporting and evaluation of HIV-related clinical endpoints in two multicenter international clinical trials

    DEFF Research Database (Denmark)

    Lifson, A; Rhame, F; Bellosa, W

    2006-01-01

    adjudication between reviewers before diagnostic certainty was assigned. CONCLUSION: Important requirements for HIV trials using clinical endpoints include objective definitions of "confirmed" and "probable," a formal reporting process with adequate information and supporting source documentation, evaluation...

  15. Formalizalization of clinical trial eligibility criteria: Evaluation of a pattern-based approach

    NARCIS (Netherlands)

    Milian, K.; Bucur, A.; ten Teije, A.C.M.; Gao, J.; Alhaij, R.; Dubitzky, W.; Ungar, L.; Wu, C.; Christianson, A,; Liebman, M.; Hu, X.

    2012-01-01

    The semi-automatic evaluation of eligibility criteria can facilitate the recruitment for clinical trials, timely completion of studies and generation of clinical evidence about new approaches to treatment, prevention and diagnosis. Because eligibility criteria are represented as free text,

  16. Evaluation of occupational health interventions using a randomized controlled trial: challenges and alternative research designs

    NARCIS (Netherlands)

    Schelvis, R.M; Oude Hengel, K.M.; Burdorf, A.; Blatter, B.M.; Strijk, J.E.; Beek, A.J. van

    2015-01-01

    Occupational health researchers regularly conduct evaluative intervention research for which a randomized controlled trial (RCT) may not be the most appropriate design (eg, effects of policy measures, organizational interventions on work schedules). This article demonstrates the appropriateness of

  17. Perioperative hyperoxia - Long-term impact on cardiovascular complications after abdominal surgery, a post hoc analysis of the PROXI trial

    DEFF Research Database (Denmark)

    Fonnes, Siv; Gogenur, Ismail; Sondergaard, Edith Smed

    2016-01-01

    BACKGROUND: Increased long-term mortality was found in patients exposed to perioperative hyperoxia in the PROXI trial, where patients undergoing laparotomy were randomised to 80% versus 30% oxygen during and after surgery. This post hoc follow-up study assessed the impact of perioperative hyperoxia...... included myocardial infarction, other heart disease, and acute coronary syndrome or death. Data were analysed in the Cox proportional hazards model. RESULTS: The primary outcome, acute coronary syndrome, occurred in 2.5% versus 1.3% in the 80% versus 30% oxygen group; HR 2.15 (95% CI 0.96-4.84). Patients...

  18. Timely and complete publication of economic evaluations alongside randomized controlled trials.

    Science.gov (United States)

    Thorn, Joanna C; Noble, Sian M; Hollingworth, William

    2013-01-01

    Little is known about the extent and nature of publication bias in economic evaluations. Our objective was to determine whether economic evaluations are subject to publication bias by considering whether economic data are as likely to be reported, and reported as promptly, as effectiveness data. Trials that intended to conduct an economic analysis and ended before 2008 were identified in the International Standard Randomised Controlled Trial Number (ISRCTN) register; a random sample of 100 trials was retrieved. Fifty comparator trials were randomly drawn from those not identified as intending to conduct an economic study. The trial start and end dates, estimated sample size and funder type were extracted. For trials planning economic evaluations, effectiveness and economic publications were sought; publication dates and journal impact factors were extracted. Effectiveness abstracts were assessed for whether they reached a firm conclusion that one intervention was most effective. Primary investigators were contacted about reasons for non-publication of results, or reasons for differential publication strategies for effectiveness and economic results. Trials planning an economic study were more likely to be funded by government (p = 0.01) and larger (p = 0.003) than other trials. The trials planning an economic evaluation had a mean of 6.5 (range 2.7-13.2) years since the trial end in which to publish their results. Effectiveness results were reported by 70 %, while only 43 % published economic evaluations (p economic results included the intervention being ineffective, and staffing issues. Funding source, time since trial end and length of study were not associated with a higher probability of publishing the economic evaluation. However, studies that were small or of unknown size were significantly less likely to publish economic evaluations than large studies (p journal impact factor was 1.6 points higher for effectiveness publications than for the

  19. The effects of the mediterranean diet on biomarkers of vascular wall inflammation and plaque vulnerability in subjects with high risk for cardiovascular disease. A randomized trial.

    Science.gov (United States)

    Casas, Rosa; Sacanella, Emilio; Urpí-Sardà, Mireia; Chiva-Blanch, Gemma; Ros, Emilio; Martínez-González, Miguel-Angel; Covas, Maria-Isabel; Salas-Salvadó, Jordi; Fiol, Miquel; Arós, Fernando; Estruch, Ramon

    2014-01-01

    Adherence to the Mediterranean diet (MD) is associated with reduced morbidity and mortality due to cardiovascular disease. However, how the MD exerts its effects is not fully known. To assess the 12-month effects of two enhanced MDs compared to a low-fat diet on inflammatory biomarkers related to atherosclerosis and plaque vulnerability in a subcohort of the PREDIMED (Prevención con Dieta Mediterránea) study. A total of 164 participants at high risk for cardiovascular disease were randomized into three diet groups: MD supplemented with 50mL/d of extra virgin olive oil (MD+EVOO) or 30 g/d of nuts (MD+Nuts) and a low-fat diet. Changes in classical cardiovascular risk factors, inflammatory biomarkers of atherosclerosis and plaque vulnerability were measured after 12 months of intervention. Compared to participants in the low-fat diet group, those receiving MD+EVOO and MD+Nuts showed a higher decrease in systolic (6mmHg) and diastolic (3mmHg) blood pressure (P = 0.02; both), as well as a reduction of 10% and 8% in LDL-cholesterol (P = 0.04), respectively. Patients in the MD+Nuts group showed a significant reduction of 34% in CD40 expression on monocyte surface compared to low-fat diet patients (P = 0.03). In addition, inflammatory biomarkers related to plaque instability such as C-reactive protein and interleukin-6 were reduced by 45% and 35% and 95% and 90% in the MD+EVOO and MD+Nuts groups, respectively (P<0.05; all) compared to the low-fat diet group. Likewise, sICAM and P-selectin were also reduced by 50% and 27%, respectively in the MD+EVOO group (P = 0.04) and P-selectin by 19% in MD+Nuts group (P = 0.04) compared to the low-fat diet group. Adherence to the MD is associated with an increase in serum markers of atheroma plaque stability which may explain, at least in part, the protective role of MD against ischemic heart disease. www.controlled-trials.com ISRCTN35739639.

  20. A path analysis of a randomized promotora de salud cardiovascular disease-prevention trial among at-risk Hispanic adults.

    Science.gov (United States)

    de Heer, Hendrik Dirk; Balcazar, Hector G; Castro, Felipe; Schulz, Leslie

    2012-02-01

    This study assessed effectiveness of an educational community intervention taught by promotoras de salud in reducing cardiovascular disease (CVD) risk among Hispanics using a structural equation modeling (SEM) approach. Model development was guided by a social ecological framework proposing CVD risk reduction through improvement of protective health behaviors, health beliefs, contextual and social factors. Participants were 328 Hispanic adults with at least one CVD risk factor. SEM analyses assessed direct and indirect effects of intervention participation on CVD risk (Framingham score) and latent variables nutrition intake and health beliefs. The model fit was adequate (root mean square error of approximation = .056 [90% confidence interval = .040, .072], comparative fit index = .967, normed fit index = .938, nonnormed fit index = .947). Intervention participation was associated with improved nutritional consumption, but not lower CVD risk. Stronger health beliefs predicted healthier nutritional habits. This project provided evidence for the adequacy of a conceptual framework that can be used to elicit new pathways toward CVD risk reduction among at-risk Hispanic populations.

  1. Evaluation of cluster-randomized trials on maternal and child health research in developing countries

    DEFF Research Database (Denmark)

    Handlos, Line Neerup; Chakraborty, Hrishikesh; Sen, Pranab Kumar

    2009-01-01

    To summarize and evaluate all publications including cluster-randomized trials used for maternal and child health research in developing countries during the last 10 years. METHODS: All cluster-randomized trials published between 1998 and 2008 were reviewed, and those that met our criteria...... for inclusion were evaluated further. The criteria for inclusion were that the trial should have been conducted in maternal and child health care in a developing country and that the conclusions should have been made on an individual level. Methods of accounting for clustering in design and analysis were......, and the trials generally improved in quality. CONCLUSIONS: Shortcomings exist in the sample-size calculations and in the analysis of cluster-randomized trials conducted during maternal and child health research in developing countries. Even though there has been improvement over time, further progress in the way...

  2. Evaluation of a Web-Based E-Learning Platform for Brief Motivational Interviewing by Nurses in Cardiovascular Care: A Pilot Study.

    Science.gov (United States)

    Fontaine, Guillaume; Cossette, Sylvie; Heppell, Sonia; Boyer, Louise; Mailhot, Tanya; Simard, Marie-Josée; Tanguay, Jean-Francois

    2016-08-18

    . At 30 days, 28 of the 31 participants (90%) had completed at least one session. The training was rated as highly acceptable, with the highest scores observed for information quality (mean 6.26, SD 0.60; scale 0-7), perceived ease of use (mean 6.16, SD 0.78; scale 0-7), and system quality (mean 6.15, SD 0.58; scale 0-7). Posttraining scores for self-reported clinical use of confidence interventions were higher than pretraining scores (mean 34.72, SD 6.29 vs mean 31.48, SD 6.75, respectively; P=.03; scale 10-50). Other results were nonsignificant. Brief MI training using a Web-based e-learning platform including role-modeling videos is both feasible and acceptable according to cardiovascular care nurses. Further research is required to evaluate the e-learning platform in a randomized controlled trial. International Standard Randomized Controlled Trial Number (ISRCTN): 16510888; http://www.isrctn.com/ISRCTN16510888 (Archived by WebCite at http://www.webcitation.org/6jf7dr7bx).

  3. The effect of 12 weeks of aerobic, resistance or combination exercise training on cardiovascular risk factors in the overweight and obese in a randomized trial.

    Science.gov (United States)

    Ho, Suleen S; Dhaliwal, Satvinder S; Hills, Andrew P; Pal, Sebely

    2012-08-28

    Evidence suggests that exercise training improves CVD risk factors. However, it is unclear whether health benefits are limited to aerobic training or if other exercise modalities such as resistance training or a combination are as effective or more effective in the overweight and obese. The aim of this study is to investigate whether 12 weeks of moderate-intensity aerobic, resistance, or combined exercise training would induce and sustain improvements in cardiovascular risk profile, weight and fat loss in overweight and obese adults compared to no exercise. Twelve-week randomized parallel design examining the effects of different exercise regimes on fasting measures of lipids, glucose and insulin and changes in body weight, fat mass and dietary intake. Participants were randomized to either: Group 1 (Control, n = 16); Group 2 (Aerobic, n = 15); Group 3 (Resistance, n = 16); Group 4 (Combination, n = 17). Data was analysed using General Linear Model to assess the effects of the groups after adjusting for baseline values. Within-group data was analyzed with the paired t-test and between-group effects using post hoc comparisons. Significant improvements in body weight (-1.6%, p = 0.044) for the Combination group compared to Control and Resistance groups and total body fat compared to Control (-4.4%, p = 0.003) and Resistance (-3%, p = 0.041). Significant improvements in body fat percentage (-2.6%, p = 0.008), abdominal fat percentage (-2.8%, p = 0.034) and cardio-respiratory fitness (13.3%, p = 0.006) were seen in the Combination group compared to Control. Levels of ApoB48 were 32% lower in the Resistance group compared to Control (p = 0.04). A 12-week training program comprising of resistance or combination exercise, at moderate-intensity for 30 min, five days/week resulted in improvements in the cardiovascular risk profile in overweight and obese participants compared to no exercise. From our observations, combination exercise gave greater benefits for weight loss

  4. The effect of 12 weeks of aerobic, resistance or combination exercise training on cardiovascular risk factors in the overweight and obese in a randomized trial

    Directory of Open Access Journals (Sweden)

    Ho Suleen S

    2012-08-01

    Full Text Available Abstract Background Evidence suggests that exercise training improves CVD risk factors. However, it is unclear whether health benefits are limited to aerobic training or if other exercise modalities such as resistance training or a combination are as effective or more effective in the overweight and obese. The aim of this study is to investigate whether 12 weeks of moderate-intensity aerobic, resistance, or combined exercise training would induce and sustain improvements in cardiovascular risk profile, weight and fat loss in overweight and obese adults compared to no exercise. Methods Twelve-week randomized parallel design examining the effects of different exercise regimes on fasting measures of lipids, glucose and insulin and changes in body weight, fat mass and dietary intake. Participants were randomized to either: Group 1 (Control, n = 16; Group 2 (Aerobic, n = 15; Group 3 (Resistance, n = 16; Group 4 (Combination, n = 17. Data was analysed using General Linear Model to assess the effects of the groups after adjusting for baseline values. Within-group data was analyzed with the paired t-test and between-group effects using post hoc comparisons. Results Significant improvements in body weight (−1.6%, p = 0.044 for the Combination group compared to Control and Resistance groups and total body fat compared to Control (−4.4%, p = 0.003 and Resistance (−3%, p = 0.041. Significant improvements in body fat percentage (−2.6%, p = 0.008, abdominal fat percentage (−2.8%, p = 0.034 and cardio-respiratory fitness (13.3%, p = 0.006 were seen in the Combination group compared to Control. Levels of ApoB48 were 32% lower in the Resistance group compared to Control (p = 0.04. Conclusion A 12-week training program comprising of resistance or combination exercise, at moderate-intensity for 30 min, five days/week resulted in improvements in the cardiovascular risk profile in overweight and obese

  5. [Evaluation of therapeutic trials published apropos of antibiotic prophylaxis in orthopedic surgery].

    Science.gov (United States)

    Doyon, F; Evrard, J; Mazas, F

    1989-01-01

    The authors review all the randomized clinical trials published since 1970 which evaluate the efficacy of antibiotic prophylaxis in orthopaedic surgery. Evaluation of the quality of these trials was based on two clinical and four methodological criteria. They also take into account reports which aim to define the best antibiotic prophylactic protocol, particularly with regard to the duration of treatment. In conclusion, although the majority of trials do not escape criticism, the efficacy of antibiotic prophylaxis in orthopaedic surgery can be considered as demonstrated. The duration of treatment is still an open problem. At the present time, the duration of drainage defines the length of antibiotherapy.

  6. Association between baseline vitamin D metabolite levels and long-term cardiovascular events in patients with rheumatoid arthritis from the CIMESTRA trial

    DEFF Research Database (Denmark)

    Herly, M; Stengaard-Pedersen, K; Hørslev-Petersen, K

    2017-01-01

    INTRODUCTION: Cardiovascular morbidity and mortality is increased in patients with rheumatoid arthritis (RA), and among these patients, the prevalence of hypovitaminosis D is high. Moreover, low vitamin D levels have been associated with increased cardiovascular risk in healthy subjects. OBJECTIV...

  7. Radioiodination and Bio evaluation of Some Cardiovascular Drugs for Nuclear Medicine Application

    International Nuclear Information System (INIS)

    El-Sharawy, D.M.M.

    2013-01-01

    Nuclear medicine specialists use safe, painless, and cost-effective techniques to image the body and treat disease. Nuclear medicine imaging is unique, because it provides doctors with information about both structure and function. It is a way to gather medical information that would otherwise be unavailable, require surgery, or necessitate more expensive diagnostic tests. Today, nuclear medicine offers procedures that are essential in many medical specialties, from pediatrics to cardiology to psychiatry. Radiopharmacy is the science that deals largely with the preparation, compounding, Quality Control (QC), and dispensing of radiopharmaceuticals and radioisotopes for human use. Radio pharmacists are the personnel who perform these functions at large hospitals or medical centers. They are involved in manufacturing cold kits and in developing new agents and procedures. In this thesis it was studied the labeling of Deltiazem , Nefidipine and Valsartan with iodine -125 via an electrophilic substitution reaction. The biological distribution of these tracers were studied and was found the possibility of their use in cardiovascular disorders.

  8. Development and psychometric evaluation of a cardiovascular risk and disease management knowledge assessment tool.

    Science.gov (United States)

    Rosneck, James S; Hughes, Joel; Gunstad, John; Josephson, Richard; Noe, Donald A; Waechter, Donna

    2014-01-01

    This article describes the systematic construction and psychometric analysis of a knowledge assessment instrument for phase II cardiac rehabilitation (CR) patients measuring risk modification disease management knowledge and behavioral outcomes derived from national standards relevant to secondary prevention and management of cardiovascular disease. First, using adult curriculum based on disease-specific learning outcomes and competencies, a systematic test item development process was completed by clinical staff. Second, a panel of educational and clinical experts used an iterative process to identify test content domain and arrive at consensus in selecting items meeting criteria. Third, the resulting 31-question instrument, the Cardiac Knowledge Assessment Tool (CKAT), was piloted in CR patients to ensure use of application. Validity and reliability analyses were performed on 3638 adults before test administrations with additional focused analyses on 1999 individuals completing both pretreatment and posttreatment administrations within 6 months. Evidence of CKAT content validity was substantiated, with 85% agreement among content experts. Evidence of construct validity was demonstrated via factor analysis identifying key underlying factors. Estimates of internal consistency, for example, Cronbach's α = .852 and Spearman-Brown split-half reliability = 0.817 on pretesting, support test reliability. Item analysis, using point biserial correlation, measured relationships between performance on single items and total score (P knowledge instrument specifically designed for an adult CR population was systematically developed and tested in a large representative patient population, satisfying psychometric parameters, including validity and reliability.

  9. Perioperative brain damage after cardiovascular surgery; Clinical evaluation including CT scans

    Energy Technology Data Exchange (ETDEWEB)

    Maruyama, Michiyuki; Kuriyama, Yoshihiro; Sawada, Toru; Fujita, Tsuyoshi; Omae, T. (National Cardiovascular Center, Suita, Osaka (Japan))

    1989-08-01

    We examined 39 cases (1.6%) of post-operative brain damages out of 2,445 sequential cases of cardiovascular surgery in NCVC during past three years. In this study, we investigated clinical course and CT findings of each patient in details and analyzed the causes of the post operative brain damages. Of 39 cases, 23 (59%) were complicated with cerebral ischemia, 8 (21%) with subdural hematoma (SDH), 2 (5%) with intracranial hemorrhage (ICH) and 1 (2%) with subarachnoid hemorrhage (SAH), respectively. 5 cases (13%) had unclassified brain damages. In 23 cases of cerebral ischemia there were 5 cases of hypotension-induced ischemia, 4 cases of hypoxic encephalopathy, 3 cases of ischemia induced by intra-operative maneuvers, 3 cases of embolism after operation and a single case of 'microembolism'. Seven cases could not be classified into any of these categories. Duration of ECC was 169.9 {plus minus} 48.5 min on the average in patients with such brain damages as SDH, ICH, SAH and cardiogenic embolism, which were thought not to be related with ECC. On the other hand, that of the patients hypotensive ischemia or 'microembolism' gave an average value of 254.5 {plus minus} 96.8 min. And these patients were thought to have occurred during ECC. There was a statistically significant difference between these two mean values. (J.P.N.).

  10. Repaired tetralogy of Fallot: the roles of cardiovascular magnetic resonance in evaluating pathophysiology and for pulmonary valve replacement decision support

    Science.gov (United States)

    2011-01-01

    Surgical management of tetralogy of Fallot (TOF) results in anatomic and functional abnormalities in the majority of patients. Although right ventricular volume load due to severe pulmonary regurgitation can be tolerated for many years, there is now evidence that the compensatory mechanisms of the right ventricular myocardium ultimately fail and that if the volume load is not eliminated or reduced by pulmonary valve replacement the dysfunction might be irreversible. Cardiovascular magnetic resonance (CMR) has evolved during the last 2 decades as the reference standard imaging modality to assess the anatomic and functional sequelae in patients with repaired TOF. This article reviews the pathophysiology of chronic right ventricular volume load after TOF repair and the risks and benefits of pulmonary valve replacement. The CMR techniques used to comprehensively evaluate the patient with repaired TOF are reviewed and the role of CMR in supporting clinical decisions regarding pulmonary valve replacement is discussed. PMID:21251297

  11. A systematic review of economic evaluations of interventions to tackle cardiovascular disease in low- and middle-income countries

    Directory of Open Access Journals (Sweden)

    Suhrcke Marc

    2012-01-01

    Full Text Available Abstract Background Low-and middle-income countries are facing both a mounting burden of cardiovascular disease (CVD as well as severe resource constraints that keep them from emulating some of the extensive strategies pursued in high-income countries. There is thus an urgency to identify and implement those interventions that help reap the biggest reductions of the CVD burden, given low resource levels. What are the interventions to combat CVDs that represent good "value for money" in low-and middle-income countries? This study reviews the evidence-base on economic evaluations of interventions located in those countries. Methods We conducted a systematic literature review of journal articles published until 2009, based on a comprehensive key-word based search in generic and specialized electronic databases, accompanied by manual searches of expert databases. The search strategy consisted of freetext and MeSH terms related to economic evaluation and cardiovascular disease. Two independent reviewers verified fulfillment of inclusion criteria and extracted study characteristics. Results Thirty-three studies met the selection criteria. We find a growing research interest, in particular in most recent years, if from a very low baseline. Most interventions fall under the category primary prevention, as opposed to case management or secondary prevention. Across the spectrum of interventions, pharmaceutical strategies have been the predominant focus, and, taken at face value, these show significant positive economic evidence, specifically when compared to the counterfactual of no interventions. Only a few studies consider non-clinical interventions, at population level. Almost half of the studies have modelled the intervention effectiveness based on existing risk-factor information and effectiveness evidence from high-income countries. Conclusion The cost-effectiveness evidence on CVD interventions in developing countries is growing, but remains scarce

  12. Comparing the effectiveness of an enhanced MOtiVational intErviewing InTervention (MOVE IT) with usual care for reducing cardiovascular risk in high risk subjects: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Bayley, Adam; de Zoysa, Nicole; Cook, Derek G; Whincup, Peter H; Stahl, Daniel; Twist, Katherine; Ridge, Katie; McCrone, Paul; Treasure, Janet; Ashworth, Mark; Greenough, Anne; Blythe, Clare; Winkley, Kirsty; Ismail, Khalida

    2015-03-25

    Interventions targeting multiple risk factors for cardiovascular disease (CVD), including poor diet and physical inactivity, are more effective than interventions targeting a single risk factor. A motivational interviewing (MI) intervention can provide modest dietary improvements and physical activity increases, while adding cognitive behaviour therapy (CBT) skills may enhance the effects of MI. We designed a randomised controlled trial (RCT) to examine whether specific behaviour change techniques integrating MI and CBT result in favourable changes in weight and physical activity in those at high risk of CVD. A group and individual intervention will be compared to usual care. A group intervention offers potential benefits from social support and may be more cost effective. Individuals aged between 40 and 74 years in 11 South London Clinical Commissioning Groups who are at high risk of developing CVD (≥20%) in the next 10 years will be recruited. A sample of 1,704 participants will be randomised to receive the enhanced MI intervention, delivered by trained healthy lifestyle facilitators (HLFs), in group or individual formats, in 10 sessions (plus an introductory session) over one year, or usual care. Randomisation will be conducted by King's College London Clinical Trials Unit and researchers collecting outcome data will be blinded to treatment allocation. At 12-month and 24-month follow-up assessments, primary outcomes will be change in weight and physical activity (average steps per day). Secondary outcomes include changes in low-density lipoprotein cholesterol and CVD risk score. Incidence of CVD events since baseline will be recorded. A process evaluation will be conducted to evaluate factors which impact on delivery, adherence and outcome. An economic evaluation will estimate relative cost-effectiveness of each type of intervention delivery. This RCT assesses the effectiveness of a healthy lifestyle intervention for people at high risk of CVD. Benefits of the

  13. Evaluation of ion release, cytotoxicity, and platelet adhesion of electrochemical anodized 316 L stainless steel cardiovascular stents.

    Science.gov (United States)

    Díaz, M; Sevilla, P; Galán, A M; Escolar, G; Engel, E; Gil, F J

    2008-11-01

    316L Stainless steel is one of the most used metallic material in orthopedical prosthesis, osteosinthesis plates, and cardiovascular stents. One of the main problems this material presents is the nickel and chromium release, specially the Ni ion release that provokes allergy in a high number of patients. Recently, experimental applications in vitro and in vivo seem to indicate that the thickness of the nature oxide of the stainless steel results in very strong reinforcement of the biological response and reduce the ion release due to the thicker surface oxide. It is possible to grow the natural chromium oxide layer by electrolytic method such anodization. In this study, two main anodization methods to grow chromium oxide on the 316L stainless steel have been evaluated. Nickel and Chromium ions release in human blood at 37 degrees C were detected at times of 1, 6, 11, and 15 days by means of atomic absorption in a graphite furnace (GAAF). Moreover, cytocompatibility tests were carried out. Perfusion experiments were performed to evaluate morphometrically platelet interaction with the material and to explore the potential thrombogenicity. The results showed a good cytocompatibility between the material and the osteoblast-like cells. However, these anodization methods released between 2 and 10 times more nickel and chromium than the original stainless steel, depending on the method used. Besides, anodized samples shown an increase of the percentage of surface covered by platelets. Consequently, the anodization methods studied do not improve the long-term behavior of the stainless steel for its application as cardiovascular stents.

  14. Favourable hypotensive effect after standardised tomato extract treatment in hypertensive subjects at high cardiovascular risk: a randomised controlled trial.

    Science.gov (United States)

    Krasińska, Beata; Osińska, Angelika; Krasińska, Aleksandra; Osiński, Maciej; Rzymski, Piotr; Tykarski, Andrzej; Krasiński, Zbigniew

    2018-01-01

    Cardiovascular (CV) diseases remain a leading global cause of death. Lowering blood pressure (BP) reduces the risk of CV complications, especially stroke and acute coronary events, and it delays the progression of kidney disease. Adequate non-pharmacological treatment improves the effectiveness of the antihypertensive therapy. A Mediterranean diet with high content of vegetables (rich in tomatoes) is associated with a reduced CV risk. The main objective of the present study was to assess whether the addition of standardised tomato extract (STE) or acetylsalicylic acid (ASA) to standard antihypertensive therapy can improve BP control in patients with arterial hypertension (HT). The study involved 82 high-risk hypertensive patients. Patients with primary HT at high to a very high total CV risk were randomised in a blinded fashion to one of two groups, i.e. the ASA and STE group. The patients had two visits, a baseline visit and one after four weeks of treatment. In all the patients, during each visit, clinical BP and ambulatory BP measurements (ABPM) were performed. Platelet aggregation was determined using the VerifyNow analyser. After four weeks of treatment in the STE group, there was a statistically significant reduction in 24-h systolic BP, diastolic BP, and mean arterial pressure values measured in ABPM (p high CV risk. This effect, together with the anti-aggregatory effect, may indicate the pleiotropic effect of tomato extract. This fact justifies further research into functional foods and gives new insights into STE as a food supplement that could have new therapeutic and prophylactic uses for the treatment of hypertensive patients with high CV risk and especially with obesity.

  15. Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors: a randomised controlled trial

    DEFF Research Database (Denmark)

    NN, NN; Yusuf, S; Teo, K

    2008-01-01

    BACKGROUND: Angiotensin-converting enzyme (ACE) inhibitors reduce major cardiovascular events, but are not tolerated by about 20% of patients. We therefore assessed whether the angiotensin-receptor blocker telmisartan would be effective in patients intolerant to ACE inhibitors with cardiovascular...... of cardiovascular death, myocardial infarction, or stroke. FUNDING: Boehringer Ingelheim....

  16. Long-term effects of 4 popular diets on weight loss and cardiovascular risk factors: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Atallah, Renée; Filion, Kristian B; Wakil, Susan M; Genest, Jacques; Joseph, Lawrence; Poirier, Paul; Rinfret, Stéphane; Schiffrin, Ernesto L; Eisenberg, Mark J

    2014-11-01

    We conducted a systematic review to examine the efficacy of the Atkins, South Beach, Weight Watchers (WW), and Zone diets, with a particular focus on sustained weight loss at ≥12 months. We systematically searched MEDLINE, EMBASE, and the Cochrane Library of Clinical Trials to identify randomized controlled trials (RCTs) published in English with follow-up ≥4 weeks that examined the effects of these 4 popular diets on weight loss and cardiovascular risk factors. We identified 12 RCTs (n=2559) with follow-up ≥12 months: 10 versus usual care (5 Atkins, 4 WW, and 1 South Beach) and 2 head-to-head (1 of Atkins, WW, and Zone, and 1 of Atkins, Zone, and control). At 12 months, the 10 RCTs comparing popular diets to usual care revealed that only WW was consistently more efficacious at reducing weight (range of mean changes: -3.5 to -6.0 kg versus -0.8 to -5.4 kg; PZone (-1.6 to -3.2 kg), and control (-2.2 kg) all achieved modest long-term weight loss. Twenty-four-month data suggest that weight lost with Atkins or WW is partially regained over time. Head-to-head RCTs, providing the most robust evidence available, demonstrated that Atkins, WW, and Zone achieved modest and similar long-term weight loss. Despite millions of dollars spent on popular commercial diets, data are conflicting and insufficient to identify one popular diet as being more beneficial than the others. © 2014 American Heart Association, Inc.

  17. Esomeprazole for prevention and resolution of upper gastrointestinal symptoms in patients treated with low-dose acetylsalicylic acid for cardiovascular protection: the OBERON trial.

    Science.gov (United States)

    Scheiman, James M; Herlitz, Johan; Veldhuyzen van Zanten, Sander J; Lanas, Angel; Agewall, Stefan; Nauclér, Emma C; Svedberg, Lars-Erik; Nagy, Péter

    2013-03-01

    Although low-dose acetylsalicylic acid (ASA) is recommended for prevention of cardiovascular events in at-risk patients, its long-term use can be associated with the risk of peptic ulcer and upper gastrointestinal (GI) symptoms that may impact treatment compliance. This prespecified secondary analysis of the OBERON study (NCT00441727) determined the efficacy of esomeprazole for prevention/resolution of low-dose ASA-associated upper GI symptoms. A post hoc analysis of predictors of symptom prevention/resolution was also conducted. Helicobacter pylori-negative patients taking low-dose ASA (75-325 mg) for cardiovascular protection who had ≥1 upper GI risk factor were eligible. The patients were randomized to once-daily esomeprazole 40 mg, 20 mg, or placebo, for 26 weeks; 2303 patients (mean age 67.6 years; 36% aged >70 years) were evaluable for upper GI symptoms. The proportion of patients with dyspeptic or reflux symptoms (self-reported Reflux Disease Questionnaire) was significantly lower (P 70 years (P upper GI symptoms at baseline (P upper GI symptoms. Together, these analyses demonstrate that esomeprazole is effective in preventing and resolving patient-reported upper GI symptoms in low-dose ASA users at increased GI risk.

  18. Predictors of fatal and nonfatal cardiovascular events in patients with type 2 diabetes mellitus, chronic kidney disease, and anemia : An analysis of the Trial to Reduce cardiovascular Events with Aranesp (darbepoetin-alfa) Therapy (TREAT)

    NARCIS (Netherlands)

    McMurray, John J. V.; Uno, Hajime; Jarolim, Petr; Desai, Akshay S.; de Zeeuw, Dick; Eckardt, Kai-Uwe; Ivanovich, Peter; Levey, Andrew S.; Lewis, Eldrin F.; McGill, Janet B.; Parfrey, Patrick; Parving, Hans-Henrik; Toto, Robert M.; Solomon, Scott D.; Pfeffer, Marc A.

    2011-01-01

    Aims This study aims to examine predictors of cardiovascular mortality and morbidity in patients with chronic kidney disease (CKD). Individuals with the triad of diabetes, CKD, and anemia represent a significant proportion of patients with cardiovascular disease and are at particularly high risk for

  19. The non-alcoholic fraction of beer increases stromal cell derived factor 1 and the number of circulating endothelial progenitor cells in high cardiovascular risk subjects: a randomized clinical trial.

    Science.gov (United States)

    Chiva-Blanch, Gemma; Condines, Ximena; Magraner, Emma; Roth, Irene; Valderas-Martínez, Palmira; Arranz, Sara; Casas, Rosa; Martínez-Huélamo, Miriam; Vallverdú-Queralt, Anna; Quifer-Rada, Paola; Lamuela-Raventos, Rosa M; Estruch, Ramon

    2014-04-01

    Moderate alcohol consumption is associated with a decrease in cardiovascular risk, but fermented beverages seem to confer greater cardiovascular protection due to their polyphenolic content. Circulating endothelial progenitor cells (EPC) are bone-marrow-derived stem cells with the ability to repair and maintain endothelial integrity and function and are considered as a surrogate marker of vascular function and cumulative cardiovascular risk. Nevertheless, no study has been carried out on the effects of moderate beer consumption on the number of circulating EPC in high cardiovascular risk patients. To compare the effects of moderate consumption of beer, non-alcoholic beer and gin on the number of circulating EPC and EPC-mobilizing factors. In this crossover trial, 33 men at high cardiovascular risk were randomized to receive beer (30 g alcohol/d), the equivalent amount of polyphenols in the form of non-alcoholic beer, or gin (30 g alcohol/d) for 4 weeks. Diet and physical exercise were carefully monitored. The number of circulating EPC and EPC-mobilizing factors were determined at baseline and after each intervention. After the beer and non-alcoholic beer interventions, the number of circulating EPC significantly increased by 8 and 5 units, respectively, while no significant differences were observed after the gin period. In correlation, stromal cell derived factor 1 increased significantly after the non-alcoholic and the beer interventions. The non-alcoholic fraction of beer increases the number of circulating EPC in peripheral blood from high cardiovascular risk subjects. http://www.controlled-trials.com/ISRCTN95345245 ISRCTN95345245. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  20. Effects of Music Therapy on the Cardiovascular and Autonomic Nervous System in Stress-Induced University Students: A Randomized Controlled Trial.

    Science.gov (United States)

    Lee, Kyoung Soon; Jeong, Hyeon Cheol; Yim, Jong Eun; Jeon, Mi Yang

    2016-01-01

    Stress is caused when a particular relationship between the individual and the environment emerges. Specifically, stress occurs when an individual's abilities are challenged or when one's well-being is threatened by excessive environmental demands. The aim of this study was to measure the effects of music therapy on stress in university students. Randomized controlled trial. Sixty-four students were randomly assigned to the experimental group (n = 33) or the control group (n = 31). Music therapy. Initial measurement included cardiovascular indicators (blood pressure and pulse), autonomic nervous activity (standard deviation of the normal-to-normal intervals [SDNN], normalized low frequency, normalized high frequency, low/high frequency), and subjective stress. After the first measurement, participants in both groups were exposed to a series of stressful tasks, and then a second measurement was conducted. The experimental group then listened to music for 20 minutes and the control group rested for 20 minutes. A third and final measurement was then taken. There were no significant differences between the two groups in the first or second measurement. However, after music therapy, the experimental group and the control group showed significant differences in all variables, including systolic blood pressure (p = .026), diastolic blood pressure (p = .037), pulse (p stress (p = .026). Classical music tends to relax the body and may stimulate the parasympathetic nervous system. These results suggest music therapy as an intervention for stress reduction.