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Clinical Trials in Canada / NCT01114269
Active, not recruiting Observational

PRE-DETERMINE Cohort Study

NCT01114269 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2007-07
Last updated
2025-10-07

Condition(s) studied

Coronary Artery DiseaseLeft Ventricular DysfunctionSudden Cardiac Death

Study 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 determine whether biologic markers and ECGs can be utilized to advance SCD risk prediction in patients with CHD and LVEF\>30-35%. The overarching goal of the 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\> 30-35%). If biologic or ECG 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Evidence of Coronary Artery Disease (CAD) a or documented prior Myocardial Infarction. 2. LVEF \>35% by any current standard evaluation technique (e.g.,) echocardiogram, MUGA, angiography). 2.1. Patients who have an LVEF between 30-35% and NYHA Class I heart failure who do not have history of ventricular tachyarrhythmias,or inducible ventricular tachycardia during electrophysiological (EP) testing can be enrolled. 3. If documented prior MI is not present, evidence of mild-moderate systolic Left Ventricular Dysfunction with an EF \>35- ≤50% as measured by any current standard screening technique (e.g.,echocardiogram, MUGA, angiography) must be present. 4. Patients aged 18 years or above 1. CAD will be defined as evidence of one of the following two (2) criteria: * Significant stenosis of a major epicardial vessel (\>50% proximal or 70% distal) by coronary angiography * Prior revascularization (percutaneous coronary intervention or coronary artery bypass surgery) 2. MI can be documented in the following ways: * From the MI hospitalization: Detection of a rise and fall of cardiac biomarkers \> 99th percentile of lab (e.g., CPK elevation or Troponin at least \> two times the upper limit of normal) together with myocardial ischemia with at least one of the following: * Symptoms of Ischemia * ECG changes indicative of new ischemia (new ST-T changes or new LBBB) * Development of pathological Q waves * Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality * If no report from the MI hospitalization is available, prior MI can be met by either of the following: * Development of pathological Q waves * Imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischaemic cause Exclusion Criteria: 1. History of cardiac arrest or spontaneous or inducible sustained VT (15 beats or more at a rate of 120 BPM or greater - the occurrence of cardiac arrest or spontaneous VT in the setting of an acute MI is not considered an exclusion). 2. Unexplained syncope 3. Current or planned implantable cardiac defibrillator (ICD) 4. Any condition other than cardiac disease that, in the investigator's judgment, would seriously limit life expectancy (poor survival) 5. Metastatic cancer 6. Marked valvular heart disease requiring surgical intervention 7. Current or planned cardiac, renal or liver transplant 8. Current alcohol or drug abuse 9. Unwilling or unable to provide informed consent 10. LVEF \<35% with Class II-IV CHF or LVEF \<30% 11. Participation in a clinical trial where the active treatment arm is testing an agent and/or intervention with known antiarrhythmic properties

Primary outcome measure(s)

Trial sites (90)

FacilityCityRegionStatus
Alaska Heart Institute Anchorage Alaska
Phoenix Heart, PLLC Glendale Arizona
Cardiovascular Consultants Phoenix Arizona
Beaver Medical Group/Clinical Care Research Banning California
Memorial Health System Colorado Springs Colorado
Colorado Heart and Vascular Denver Colorado
Bay Area Cardiology Associates, P.A. Brandon Florida
University of Florida - Gainsville Gainesville Florida
Reliable Clinical Research Miami Florida
Mount Sinai Medical Center Miami Beach Florida
Florida Hospital Orlando Florida
Orlando Regional Medical Center Orlando Florida
Palm Beach Gardens Research Center Palm Beach Gardens Florida
Velella Research Sarasota Florida
Tallahassee Research Institute, Inc. Tallahassee Florida
Cardiology Associates of Palm Beach - West Palm Beach West Palm Beach Florida
Georgia Heart Specialist Covington Georgia
Northeast Georgia Heart Center, P.C. Gainesville Georgia
University of Chicago Chicago Illinois
Advocate Medical Group Chicago Illinois
Advocate Medical Group - Heart and Vascular of IL Chicago Illinois
Consultants in Cardiovascular Medicine Melrose Park Illinois
Community Heart and Vascular Anderson Indiana
Iowa Heart Center West Des Moines Iowa
The University of Kansas Kansas City Kansas
Baptist Health Lexington Lexington Kentucky
Leonard J. Chabert Medical Center Houma Louisiana
Maine Research Associates Auburn Maine
Maine Research Associates - Lewiston Lewiston Maine
University of Maryland Medical Center Baltimore Maryland
Primary Care Cardiology Research Ayer Massachusetts
Brigham and Women's Hospital Boston Massachusetts
NECCR Internal Medicine and Cardiology Associates, LLC Fall River Massachusetts
Hawthorn Medical Associates North Dartmouth Massachusetts
Baystate Cardiology Springfield Massachusetts
University of Michigan Medical Center Ann Arbor Michigan
Oakwood Hospital & Medical Center Dearborn Michigan
McLaren Medical Center - Macomb Mount Clemens Michigan
Michigan Heart Ypsilanti Michigan
Minneapolis VA Medical Center Minneapolis Minnesota

+ 50 more sites — see the full list on the official registry below.

More Brigham and Women's Hospital trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01114269 on ClinicalTrials.gov ↗ ← All trials in Canada