PRE-DETERMINE Cohort Study

NCT ID: NCT01114269

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 5764 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2026-11-30

Brief 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.

Detailed Description

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 were enrolled at 135 sites where information on baseline demographics, clinical characteristics, pertinent past medical history, lifestyle habits, cardiac test results, and medications were collected via electronic data capture. Electrocardiograms along with a blood sample was also collected at baseline, sent to central laboratories, and stored for future analyses. Contrast-enhanced magnetic resonance imaging (CE-MRI) scans were collected on a subset of patients and analyzed. Enrollment closed in November 2013 and patients are now being followed centrally by the Clinical Coordinating Center via mail/phone to document interim non-fatal arrhythmic events and cause-specific mortality. Questionnaires that inquire about intervening ICD implantations, ICD therapies, cardiac arrest, and other pertinent cardiovascular endpoints are mailed to participants every six months, and follow-up telephone calls are made to non-responders. Study endpoints are being confirmed through review of medical records, interviews with next-of-kin, and autopsy reports, if available.

Conditions

Coronary Artery Disease; Left Ventricular Dysfunction; Sudden Cardiac Death

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: collaborator

Quintiles, Inc.

INDUSTRY

Sponsor Role: collaborator

Roche Diagnostic Ltd.

INDUSTRY

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Christine M. Albert, MD, MPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christine M Albert, M.D., M.P.H.

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Alaska Heart Institute

Anchorage, Alaska, United States

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

Baptist Health Lexington

Lexington, Kentucky, United States

Leonard J. Chabert Medical Center

Houma, Louisiana, United States

Maine Research Associates

Auburn, Maine, United States

Maine Research Associates - Lewiston

Lewiston, Maine, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Primary Care Cardiology Research

Ayer, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

NECCR Internal Medicine and Cardiology Associates, LLC

Fall River, Massachusetts, United States

Hawthorn Medical Associates

North Dartmouth, Massachusetts, United States

Baystate Cardiology

Springfield, Massachusetts, United States

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Oakwood Hospital & Medical Center

Dearborn, Michigan, United States

McLaren Medical Center - Macomb

Mount Clemens, Michigan, United States

Michigan Heart

Ypsilanti, Michigan, United States

Minneapolis VA Medical Center

Minneapolis, Minnesota, United States

University of Missouri Health Care

Columbia, Missouri, United States

Glacier View Cardiology

Kalispell, Montana, United States

The Cardiac Center of Creighton University

Omaha, Nebraska, United States

Advanced Heartcare, LLC

Bridgewater, New Jersey, United States

St. Joseph Regional Medical Center

Paterson, New Jersey, United States

New Mexico VA Healthcare Systems

Albuquerque, New Mexico, United States

Albany Associates Cardiology

Albany, New York, United States

Maimonides Medical Center

Brooklyn, New York, United States

Buffalo General Hospital/Kaleida Health

Buffalo, New York, United States

Jamaica Hospital Medical Center

Jamaica, New York, United States

Mid-Valley Cardiology

Kingston, New York, United States

Winthrop-University Hospital

Mineola, New York, United States

Gotham Cardiovascular

New York, New York, United States

Columbia University Health Center

New York, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

St. Elizabeth Medical Center - Hotvedt

Utica, New York, United States

Asheville Cardiology Associates

Asheville, North Carolina, United States

Eastern Carolina Cardiovascular

Elizabeth City, North Carolina, United States

Northstate Clinical Research

Lenoir, North Carolina, United States

Pinehurst Medical Clinic, Inc.

Pinehurst, North Carolina, United States

Sanford Cardiology

Sanford, North Carolina, United States

Wake Forest

Winston-Salem, North Carolina, United States

Northeast Ohio Cardiovascular Specialists

Akron, Ohio, United States

University of Cincinnati

Cincinnati, Ohio, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

North Ohio Research, Ltd.

Elyria, Ohio, United States

Mercy Medical Associates

Fairfield, Ohio, United States

Northwest Ohio Cardiology Consultants/The Toledo Hospital

Toledo, Ohio, United States

Oklahoma City VA Medical Center Veterans Research and Education Foundation

Oklahoma City, Oklahoma, United States

Oklahoma Foundation for Cardiovascular Research

Oklahoma City, Oklahoma, United States

Abington Memorial Hospital

Abington, Pennsylvania, United States

St. Luke's Bethlehem

Bethlehem, Pennsylvania, United States

Doylestown Cardiology Associates

Doylestown, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

AnMed Health

Anderson, South Carolina, United States

VA Medical Center - Charleston

Charleston, South Carolina, United States

Carolina Cardiology Associates

Rock Hill, South Carolina, United States

Black Hills Cardiovascular Research

Rapid City, South Dakota, United States

Cardiovasular Research of Knoxville

Knoxville, Tennessee, United States

Memphis VA Medical Center

Memphis, Tennessee, United States

St. Luke's Episcopal Hospital

Houston, Texas, United States

Non-Invasive Cardiovascular PA

Houston, Texas, United States

Providence Health Center

Waco, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

Cardiovascular Associates Virginia Beach

Virginia Beach, Virginia, United States

University of Alberta

Edmonton, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Mississauga Clinical Research Centre

Mississauga, Ontario, Canada

Transcatheter Medical, Inc. Centro Cardiovascular de Caguas y del Caribe

Rio Piedras, , Puerto Rico

Countries

United States; Canada; Puerto Rico

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Related Links

http://www.nlm.nih.gov/medlineplus/cardiacarrest.html

Cardiac Arrest

http://www.nlm.nih.gov/medlineplus/coronaryarterydisease.html

Coronary Artery Disease

http://www.nlm.nih.gov/medlineplus/pacemakersandimplantabledefibrillators.html

Pacemakers and Implantable Defibrillators

http://clinicaltrials.gov/ct2/info/fdalinks

U.S. FDA Resources

http://www.nlm.nih.gov/medlineplus/heartdiseases.html

Heart Disease

https://www.pre-determinestudy.org

PRE-DETERMINE Study Website

Other Identifiers

R01HL091069

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01HL165840

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2007P000840

Identifier Type: -

Identifier Source: org_study_id