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Can simple blood tests and ECGs predict sudden cardiac arrest?

NCT ID NCT01114269

Knowledge-focused Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows over 5,700 people with coronary artery disease and mild heart damage to see if blood tests and ECGs can better predict who is at risk for sudden cardiac death. The goal is to find inexpensive markers that could help doctors decide who needs a defibrillator. Participants are not given any new treatment—only monitored over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

5,764 people

The number who actually took part.

Started

Jul 2007

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants have been recruited throughout multicenter sites participating in the PRE-DETERMINE Cohort Study. Patients with a history of coronary artery disease and documentation of either a prior myocardial infarction (MI) or mild to moderate left ventricular dysfunction (LVEF 35-50%) have been enrolled. The clinical study staff at each site, which was either a research nurse, fellow, or physician approached eligible patients to discuss their potential participation.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

coronary artery disorder Death, Sudden, Cardiac left ventricular failure myocardial infarction sudden arrhythmia death syndrome sudden cardiac arrest Ventricular Dysfunction, Left

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery disease Left ventricular dysfunction Sudden cardiac death

Contacts and locations

Locations

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001, United States

  • Advanced Heartcare, LLC

    Bridgewater, New Jersey, 08807, United States

  • Advocate Medical Group

    Chicago, Illinois, 60643, United States

  • Advocate Medical Group - Heart and Vascular of IL

    Chicago, Illinois, 60657, United States

  • Alaska Heart Institute

    Anchorage, Alaska, 99508, United States

  • Albany Associates Cardiology

    Albany, New York, 12205, United States

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • AnMed Health

    Anderson, South Carolina, 29621, United States

  • Asheville Cardiology Associates

    Asheville, North Carolina, 28801, United States

  • Baptist Health Lexington

    Lexington, Kentucky, 40503, United States

  • Bay Area Cardiology Associates, P.A.

    Brandon, Florida, 33511, United States

  • Baystate Cardiology

    Springfield, Massachusetts, 01199, United States

  • Beaver Medical Group/Clinical Care Research

    Banning, California, 92220, United States

  • Black Hills Cardiovascular Research

    Rapid City, South Dakota, 57701, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Buffalo General Hospital/Kaleida Health

    Buffalo, New York, 14203, United States

  • Cardiology Associates of Palm Beach - West Palm Beach

    West Palm Beach, Florida, 33401, United States

  • Cardiovascular Associates Virginia Beach

    Virginia Beach, Virginia, 23454, United States

  • Cardiovascular Consultants

    Phoenix, Arizona, 85032, United States

  • Cardiovasular Research of Knoxville

    Knoxville, Tennessee, 37917, United States

  • Carolina Cardiology Associates

    Rock Hill, South Carolina, 29732, United States

  • Colorado Heart and Vascular

    Denver, Colorado, 80204, United States

  • Columbia University Health Center

    New York, New York, 10032, United States

  • Community Heart and Vascular

    Anderson, Indiana, 46011, United States

  • Consultants in Cardiovascular Medicine

    Melrose Park, Illinois, 60160, United States

  • Doylestown Cardiology Associates

    Doylestown, Pennsylvania, 18901, United States

  • Eastern Carolina Cardiovascular

    Elizabeth City, North Carolina, 27909, United States

  • Florida Hospital

    Orlando, Florida, 32804, United States

  • Georgia Heart Specialist

    Covington, Georgia, 30014, United States

  • Glacier View Cardiology

    Kalispell, Montana, 59901, United States

  • Gotham Cardiovascular

    New York, New York, 10001, United States

  • Hawthorn Medical Associates

    North Dartmouth, Massachusetts, 02747, United States

  • Intermountain Medical Center

    Murray, Utah, 84157, United States

  • Iowa Heart Center

    West Des Moines, Iowa, 50266, United States

  • Jamaica Hospital Medical Center

    Jamaica, New York, 11418, United States

  • Leonard J. Chabert Medical Center

    Houma, Louisiana, 70363, United States

  • Maimonides Medical Center

    Brooklyn, New York, 11219, United States

  • Maine Research Associates

    Auburn, Maine, 04210, United States

  • Maine Research Associates - Lewiston

    Lewiston, Maine, 04240, United States

  • McLaren Medical Center - Macomb

    Mount Clemens, Michigan, 48043, United States

  • Memorial Health System

    Colorado Springs, Colorado, 80909, United States

  • Memphis VA Medical Center

    Memphis, Tennessee, 38104, United States

  • Mercy Medical Associates

    Fairfield, Ohio, 45014, United States

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109, United States

  • Michigan Heart

    Ypsilanti, Michigan, 48197, United States

  • Mid-Valley Cardiology

    Kingston, New York, 12401, United States

  • Minneapolis VA Medical Center

    Minneapolis, Minnesota, 55417, United States

  • Mississauga Clinical Research Centre

    Mississauga, Ontario, L5B 2P7, Canada

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140, United States

  • NECCR Internal Medicine and Cardiology Associates, LLC

    Fall River, Massachusetts, 02720, United States

  • New Mexico VA Healthcare Systems

    Albuquerque, New Mexico, 87108, United States

  • Non-Invasive Cardiovascular PA

    Houston, Texas, 77074, United States

  • North Ohio Research, Ltd.

    Elyria, Ohio, 44035, United States

  • Northeast Georgia Heart Center, P.C.

    Gainesville, Georgia, 30501, United States

  • Northeast Ohio Cardiovascular Specialists

    Akron, Ohio, 44304, United States

  • Northstate Clinical Research

    Lenoir, North Carolina, 28645, United States

  • Northwest Ohio Cardiology Consultants/The Toledo Hospital

    Toledo, Ohio, 43615, United States

  • Oakwood Hospital & Medical Center

    Dearborn, Michigan, 48124, United States

  • Oklahoma City VA Medical Center Veterans Research and Education Foundation

    Oklahoma City, Oklahoma, 73104, United States

  • Oklahoma Foundation for Cardiovascular Research

    Oklahoma City, Oklahoma, 73120, United States

  • Orlando Regional Medical Center

    Orlando, Florida, 32806, United States

  • Palm Beach Gardens Research Center

    Palm Beach Gardens, Florida, 33410, United States

  • Phoenix Heart, PLLC

    Glendale, Arizona, 85306, United States

  • Pinehurst Medical Clinic, Inc.

    Pinehurst, North Carolina, 28374, United States

  • Primary Care Cardiology Research

    Ayer, Massachusetts, 01432, United States

  • Providence Health Center

    Waco, Texas, 76712, United States

  • Reliable Clinical Research

    Miami, Florida, 33135, United States

  • Sanford Cardiology

    Sanford, North Carolina, 27330, United States

  • St. Elizabeth Medical Center - Hotvedt

    Utica, New York, 13501, United States

  • St. Joseph Regional Medical Center

    Paterson, New Jersey, 07503, United States

  • St. Luke's Bethlehem

    Bethlehem, Pennsylvania, 18018, United States

  • St. Luke's Episcopal Hospital

    Houston, Texas, 77030, United States

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794, United States

  • Tallahassee Research Institute, Inc.

    Tallahassee, Florida, 32308, United States

  • The Cardiac Center of Creighton University

    Omaha, Nebraska, 68131, United States

  • The University of Kansas

    Kansas City, Kansas, 66160, United States

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

    Rio Piedras, 00924, Puerto Rico

  • University of Alberta

    Edmonton, Alberta, T6G 2B7, Canada

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Florida - Gainsville

    Gainesville, Florida, 32610, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109, United States

  • University of Missouri Health Care

    Columbia, Missouri, 65201, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • VA Medical Center - Charleston

    Charleston, South Carolina, 29425, United States

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Velella Research

    Sarasota, Florida, 34233, United States

  • Wake Forest

    Winston-Salem, North Carolina, 27157, United States

  • Winthrop-University Hospital

    Mineola, New York, 11501, United States

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