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PRE-DETERMINE Cohort Study

2014-07-23 21:09:22 | BioPortfolio

Summary

This is a prospective, multi-center cohort study of patients with a history of coronary artery disease (CAD) and documentation of either a prior myocardial infarction (MI) or mild to moderate left ventricular dysfunction (LVEF 35-50%). The primary objective of this study is to identify a series of markers that alone or in combination specifically predict risk of arrhythmic death as compared to other causes of mortality among this at risk population of coronary heart disease (CHD) patients with preserved left ventricular ejection fraction (LVEF> 35%). In addition, we will also address whether these promising genetic markers and biomarkers advance sudden cardiac death (SCD) risk prediction when combined with advanced substrate imaging by participants that have undergone a CE-MRI at baseline.

Description

There are an estimated 250,000-400,000 sudden cardiac deaths (SCD) annually in the United States constituting approximately 50% of all cardiac deaths. Although clinical trials have demonstrated convincing survival benefits conferred by implantable cardioverter defibrillator (ICD) therapy in selected patients with left ventricular ejection fractions (LVEF) less than 35% and congestive heart failure, the overwhelming majority of patients who suffer a cardiac arrest will have an LVEF> 0.35. The PRE-DETERMINE: Biologic Markers and MRI SCD Cohort Study seeks to identify patients at a substantially higher risk of arrhythmic death among coronary heart disease (CHD) patients with preserved left ventricular ejection fractions (LVEF>35%). If biomarkers or genetic markers are identified that can specifically predict risk of ventricular arrhythmias, then these markers may serve as relatively inexpensive methods to identify those at risk. The public health impact of identifying markers could be quite substantial, leading to more efficient utilization of ICDs and advances in our understanding of mechanisms underlying SCD.

The PRE-DETERMINE Study is a prospective, multi-center study of patients with a history of coronary artery disease (CAD) and documentation of either a prior myocardial infarction (MI) or mild to moderate left ventricular dysfunction (LVEF 35-50%). Patients will be enrolled at about 100 sites where information on baseline demographic, clinical characteristics, pertinent past medical history, lifestyle habits, and medications will be collected. Electrocardiograms along with a contrast-enhanced MRI(CE-MRI) and/or a blood sample will also be collected at baseline, sent to central laboratories, and stored for future analyses. The participants contact information will be collected and stored in a secure database and all participants will be followed centrally on a 6-month basis via mail/phone to document interim non-fatal arrhythmic events and cause-specific mortality. Study endpoints will be confirmed through review of medical records, interviews with next-of-kin, death certificates, and autopsy reports, if available.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Coronary Artery Disease

Location

Alaska Heart Institute
Anchorage
Alaska
United States
99508

Status

Recruiting

Source

Brigham and Women's Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:22-0400

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