PRE-DETERMINE Cohort Study

Running, not enrolling

Conditions studied: Coronary Artery Disease, Left Ventricular Dysfunction, Sudden Cardiac Death

In brief

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.

Key facts

Study ID: NCT01114269
Run by: Brigham and Women's Hospital
People needed: 5764
Starts: 2007-07-01
Expected to finish: 2026-11-01
Last updated by the study team: 2025-10-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Evidence of Coronary Artery Disease (CAD) a or documented prior Myocardial Infarction.
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.
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.
Patients aged 18 years or above
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)
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

You may not qualify if…

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).
Unexplained syncope
Current or planned implantable cardiac defibrillator (ICD)
Any condition other than cardiac disease that, in the investigator's judgment, would seriously limit life expectancy (poor survival)
Metastatic cancer
Marked valvular heart disease requiring surgical intervention
Current or planned cardiac, renal or liver transplant
Current alcohol or drug abuse
Unwilling or unable to provide informed consent
LVEF <35% with Class II-IV CHF or LVEF <30%
Participation in a clinical trial where the active treatment arm is testing an agent and/or intervention with known antiarrhythmic properties

Where it is running

Phoenix Heart, PLLC — Glendale, Arizona, United States
Cardiovascular Consultants — Phoenix, Arizona, United States
Beaver Medical Group/Clinical Care Research — Banning, California, United States
Memorial Health System — Colorado Springs, Colorado, United States
Colorado Heart and Vascular — Denver, Colorado, United States
Bay Area Cardiology Associates, P.A. — Brandon, Florida, United States
University of Florida - Gainsville — Gainesville, Florida, United States
Reliable Clinical Research — Miami, Florida, United States
Mount Sinai Medical Center — Miami Beach, Florida, United States
Florida Hospital — Orlando, Florida, United States
Orlando Regional Medical Center — Orlando, Florida, United States
Palm Beach Gardens Research Center — Palm Beach Gardens, Florida, United States
Velella Research — Sarasota, Florida, United States
Tallahassee Research Institute, Inc. — Tallahassee, Florida, United States
Cardiology Associates of Palm Beach - West Palm Beach — West Palm Beach, Florida, United States
Georgia Heart Specialist — Covington, Georgia, United States
Northeast Georgia Heart Center, P.C. — Gainesville, Georgia, United States
University of Chicago — Chicago, Illinois, United States
Advocate Medical Group — Chicago, Illinois, United States
Advocate Medical Group - Heart and Vascular of IL — Chicago, Illinois, United States
Consultants in Cardiovascular Medicine — Melrose Park, Illinois, United States
Community Heart and Vascular — Anderson, Indiana, United States
Iowa Heart Center — West Des Moines, Iowa, United States
The University of Kansas — Kansas City, Kansas, United States
Alaska Heart Institute — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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