Dataset Information

Putative mechanisms Underlying Myocardial infarction onset and Emotions (PUME): a randomised controlled study protocol.

ABSTRACT: INTRODUCTION:The experience of negative emotions (eg, anger, anxiety and sadness) is associated with an increased short-term risk of incident cardiovascular disease (CVD) events, independent of traditional CVD risk factors. Impairment in endothelial function is one possible biological mechanism which may explain the association between negative emotions and incident CVD events. This laboratory-based, single-blind, randomised controlled experimental study aims to investigate the impact of induced negative emotions including anger, anxiety and sadness on endothelial function. METHODS AND ANALYSIS:In a between-subjects design, 280 healthy participants are randomised to one of four experimental negative emotion inductions: anger, anxiety, sadness or a neutral condition. Endothelium-dependent vasodilation, circulating levels of endothelial cell-derived microparticles and bone marrow-derived endothelial progenitor cells, and indices of nitric oxide inhibition are assessed before and 3, 40, 70 and 100?min after negative emotion induction. Finally, in a subsample of 84 participants, the potential moderating effects of cardiorespiratory fitness and habitual physical activity on the adverse effects of an acute negative emotion on endothelial function are investigated. ETHICS AND DISSEMINATION:This study is conducted in compliance with the Helsinki Declaration and the Columbia University Medical Center Institutional Review Board. The results of the study will be disseminated at several research conferences and as published articles in peer reviewed journals. The study will be implemented and reported in line with the SPIRIT statement. TRIAL REGISTRATION NUMBER:NCT01909895; Pre-results.

SUBMITTER: Ensari I

PROVIDER: S-EPMC5988091 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Putative mechanisms Underlying Myocardial infarction onset and Emotions (PUME): a randomised controlled study protocol.

Ensari Ipek I Burg Matthew M MM Diaz Keith M KM Fu Jie J Duran Andrea T AT Suls Jerry M JM Sumner Jennifer A JA Monane Rachel R Julian Jacob E JE Zhao Shuqing S Chaplin William F WF Shimbo Daichi D

BMJ open 20180531 5

<h4>Introduction</h4>The experience of negative emotions (eg, anger, anxiety and sadness) is associated with an increased short-term risk of incident cardiovascular disease (CVD) events, independent of traditional CVD risk factors. Impairment in endothelial function is one possible biological mechanism which may explain the association between negative emotions and incident CVD events. This laboratory-based, single-blind, randomised controlled experimental study aims to investigate the impact of ...[more]

PMID: 29858417

Similar Datasets

Project description:INTRODUCTION:Acute myocardial infarction (AMI) is a major cause of death and disability in the UK and worldwide. Presently, timely and effective reperfusion with primary percutaneous coronary intervention (PPCI) remains the most effective treatment strategy for limiting infarct size, preserving left ventricular ejection fraction (LVEF) and improving clinical outcomes. However, the process of reperfusion can itself induce cardiomyocyte death, known as myocardial reperfusion injury, for which there is currently no effective therapy. Extensive preclinical evidence exists to suggest that sodium nitrite (as a source of endogenous nitric oxide) is an effective therapeutic strategy for preventing myocardial reperfusion injury. The purpose of NITRITE-AMI is to test whether sodium nitrite reduces reperfusion injury and subsequent infarct size in patients undergoing PPCI for MI. METHODS AND DESIGN:NITRITE-AMI is a double-blind, randomised, single-centre, placebo-controlled trial to determine whether intracoronary nitrite injection reduces infarct size in patients with myocardial infarction undergoing primary angioplasty. The study will enrol 80 patients presenting with ST-elevation myocardial infarction. Patients will be randomised to receive either a bolus of intracoronary sodium nitrite or placebo (sodium chloride) at the time of PPCI. The primary outcome is infarct size assessed by creatine kinase area under the curve (AUC) over 48 h. Secondary endpoints include troponin T AUC and infarct size, LV dimensions and myocardial salvage index assessed by cardiac MR (CMR), markers of platelet reactivity and inflammation, the safety and tolerability of intracoronary nitrite, and 1 year major adverse cardiac events. ETHICS AND DISSEMINATION:The study is approved by the local ethics committee (NRES Committee London West London: 11/LO/1500) and by the Medicines and Healthcare Products Regulatory Agency (MHRA) (EudraCT nr. 2010-022460-12). The results of the trial will be published according to the CONSORT statement and will be presented at conferences and reported in peer-reviewed journals. TRIAL REGISTRATION:United Kingdom Clinical Research Network (Study ID 12117), http://clinicaltrials.gov (NCT01584453) and Current Controlled Trials (ISRCTN:38736987).

Project description:<p>The NHLBI "Grand Opportunity" Exome Sequencing Project (GO-ESP), a signature project of the NHLBI Recovery Act investment, was designed to identify genetic variants in coding regions (exons) of the human genome (the "exome") that are associated with heart, lung and blood diseases. These and related diseases that are of high impact to public health and individuals from diverse racial and ethnic groups will be studied. These data may help researchers understand the causes of disease, contributing to better ways to prevent, diagnose, and treat diseases, as well as determine whether to tailor prevention and treatments to specific populations. This could lead to more effective treatments and reduce the likelihood of side effects. GO-ESP is comprised of five collaborative components: 3 cohort consortia - HeartGO, LungGO, and WHISP - and 2 sequencing centers - BroadGO and SeattleGO.</p> <p>In the Grand Opportunities Exome Sequencing Program Early MI Project (GO ESP - EOMI), we are sequencing cases with extremely early-onset MI drawn from 8 cohorts. These cohorts include five hospital or community-based studies that ascertained individuals based on MI status. These include PennCATH, Cleveland Clinic Genebank, Massachusetts General Hospital Premature Coronary Artery Disease Study (MGH-PCAD), Heart Attack Risk in Puget Sound (HARPS), and Translational Research Investigating Underlying Disparities in Myocardial Infarction Patients' Health Status (TRIUMPH). Cases were selected based on MI occurring in men aged ≤50 years and women aged ≤60 years. In addition, early-MI cases are being drawn from three population-cohort studies including the Framingham Heart Study, the Women's Health Initiative, and the Atherosclerosis Risk in Communities Study. MI-free controls are being drawn from five population-based cohort studies including the Framingham Heart Study, the Women's Health Initiative, Atherosclerosis Risk in Communities Study, Cardiovascular Health Study, and the Jackson Heart Study. Controls were selected based on two factors: (1) highest predicted risk for MI based on Framingham risk score; and (2) absence of prevalent or incident MI despite a high predicted risk.</p>

Project description:OBJECTIVE:To evaluate an informed shared decision-making programme (ISDM-P) for people with type 2 diabetes under high fidelity conditions. DESIGN:Randomised, single-blinded trial with sham control intervention and follow-up of 6 months. SETTING:Single-centre diabetes clinic providing care according to the national disease management programme in Germany. PARTICIPANTS:154 people with type 2 diabetes without diagnosis of ischaemic heart disease or stroke. INTERVENTIONS:The ISDM-P is executed by diabetes educators. Core component is a patient decision aid on the prevention of myocardial infarction supplemented by a 90 min group teaching session. The structurally equivalent control intervention addresses stress issues. MAIN OUTCOME MEASURES:Primary outcome was risk comprehension, including realistic expectations about benefits and harms of interventions. It was assessed by a 12-item questionnaire after the teaching session when patients set and prioritise their treatment goals. Key secondary outcome was adherence to treatment goals, operationalised as achievement of individual goals and medication uptake. ISDM-P teaching sessions were video-taped to monitor intervention fidelity. RESULTS:72 of 77 ISDM-P and 71 of 77 control patients completed the questionnaire (score 0-12). ISDM-P patients achieved higher levels of risk comprehension, mean score 8.25 vs 2.62, difference 5.63 (95% CI 4.82 to 6.44), and realistic expectations (score 0-6), 4.51 vs 0.85, 3.67 (3.23 to 4.11). More ISDM-P patients wished to take statins, 59.2% vs 30.4%, 28.7% (12.9% to 44.5%); more prioritised blood pressure control, 51.4% vs 25.7%, and fewer intensive glucose control, 33.3% vs 60%, p=0.002. More ISDM-P patients achieved their glycated haemoglobin goals, 95.8% vs 85.7%, 10.1% (0.6% to 19.5%). Achievement of prioritised goals and medication uptake were comparable between groups. CONCLUSIONS:The ISDM-P on preventive measures in type 2 diabetes was effective under high fidelity conditions. Involvement of diabetes educators may facilitate implementation of the informed shared decision-making. TRIAL REGISTRATION NUMBER:ISRCTN84636255.

Dataset Information

Putative mechanisms Underlying Myocardial infarction onset and Emotions (PUME): a randomised controlled study protocol.

Publications

Putative mechanisms Underlying Myocardial infarction onset and Emotions (PUME): a randomised controlled study protocol.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets