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)
Sudden and/or arrhythmic cardiac death or resuscitated ventricular fibrillation. — Median follow-up estimated to be 10.7 years A definite sudden cardiac death (SCD) is defined as a death or fatal cardiac arrest occurring within 1 hour of symptom onset or the presence of autopsy consistent with SCD (e.g. acute coronary thrombosis). Probable SCD is defined as an unwitnessed death or death during sleep where the participant was observed to be symptom-free within the preceding 24 hours. Arrhythmic death is defined as the abrupt spontaneous collapse of circulation without antecedent circulatory or neurologic impairment. Deaths classified as non-arrhythmic are not included in the primary endpoint regardless of timing. Resuscitated ventricular fibrillation is defined as out-of-hospital cardiac arrests with documented VF and/or use of external electrical defibrillation for resuscitation.
Trial sites (90)
Facility
City
Region
Status
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
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.
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