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Coronary Artery DiseaseNCT01114269

PRE-DETERMINE Cohort Study

An observational study of Coronary Artery Disease and Left Ventricular Dysfunction, run by Brigham and Women's Hospital at 90 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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%). Read more about this study

Who is it for?
Ages 18 years and older
How many people
5,764 participants
Where
90 sitesin 3 countries
Study dates
Jul 2007to Nov 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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
Show all 16Show fewer
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

90 sites in 3 countries.

90 sites in 3 countries

United States86 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Northeast Ohio Cardiovascular Specialists

    Akron, Ohio, 44304

  • Albany Associates Cardiology

    Albany, New York, 12205

  • New Mexico VA Healthcare Systems

    Albuquerque, New Mexico, 87108

  • Alaska Heart Institute

    Anchorage, Alaska, 99508

  • Community Heart and Vascular

    Anderson, Indiana, 46011

  • AnMed Health

    Anderson, South Carolina, 29621

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109

  • Asheville Cardiology Associates

    Asheville, North Carolina, 28801

  • Maine Research Associates

    Auburn, Maine, 04210

  • Primary Care Cardiology Research

    Ayer, Massachusetts, 01432

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Beaver Medical Group/Clinical Care Research

    Banning, California, 92220

  • St. Luke's Bethlehem

    Bethlehem, Pennsylvania, 18018

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Bay Area Cardiology Associates, P.A.

    Brandon, Florida, 33511

  • Advanced Heartcare, LLC

    Bridgewater, New Jersey, 08807

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • Buffalo General Hospital/Kaleida Health

    Buffalo, New York, 14203

  • VA Medical Center - Charleston

    Charleston, South Carolina, 29425

  • University of Chicago

    Chicago, Illinois, 60637

  • Advocate Medical Group

    Chicago, Illinois, 60643

  • Advocate Medical Group - Heart and Vascular of IL

    Chicago, Illinois, 60657

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Memorial Health System

    Colorado Springs, Colorado, 80909

  • University of Missouri Health Care

    Columbia, Missouri, 65201

  • Georgia Heart Specialist

    Covington, Georgia, 30014

  • Oakwood Hospital & Medical Center

    Dearborn, Michigan, 48124

  • Colorado Heart and Vascular

    Denver, Colorado, 80204

  • Doylestown Cardiology Associates

    Doylestown, Pennsylvania, 18901

  • Eastern Carolina Cardiovascular

    Elizabeth City, North Carolina, 27909

  • North Ohio Research, Ltd.

    Elyria, Ohio, 44035

  • Mercy Medical Associates

    Fairfield, Ohio, 45014

  • NECCR Internal Medicine and Cardiology Associates, LLC

    Fall River, Massachusetts, 02720

  • University of Florida - Gainsville

    Gainesville, Florida, 32610

  • Northeast Georgia Heart Center, P.C.

    Gainesville, Georgia, 30501

  • Phoenix Heart, PLLC

    Glendale, Arizona, 85306

  • Leonard J. Chabert Medical Center

    Houma, Louisiana, 70363

  • St. Luke's Episcopal Hospital

    Houston, Texas, 77030

  • Non-Invasive Cardiovascular PA

    Houston, Texas, 77074

  • Jamaica Hospital Medical Center

    Jamaica, New York, 11418

  • Glacier View Cardiology

    Kalispell, Montana, 59901

  • The University of Kansas

    Kansas City, Kansas, 66160

  • Mid-Valley Cardiology

    Kingston, New York, 12401

  • Cardiovasular Research of Knoxville

    Knoxville, Tennessee, 37917

  • Northstate Clinical Research

    Lenoir, North Carolina, 28645

  • Maine Research Associates - Lewiston

    Lewiston, Maine, 04240

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Consultants in Cardiovascular Medicine

    Melrose Park, Illinois, 60160

  • Memphis VA Medical Center

    Memphis, Tennessee, 38104

  • Reliable Clinical Research

    Miami, Florida, 33135

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Winthrop-University Hospital

    Mineola, New York, 11501

  • Minneapolis VA Medical Center

    Minneapolis, Minnesota, 55417

  • McLaren Medical Center - Macomb

    Mount Clemens, Michigan, 48043

  • Intermountain Medical Center

    Murray, Utah, 84157

  • Gotham Cardiovascular

    New York, New York, 10001

  • Columbia University Health Center

    New York, New York, 10032

  • Hawthorn Medical Associates

    North Dartmouth, Massachusetts, 02747

  • Oklahoma City VA Medical Center Veterans Research and Education Foundation

    Oklahoma City, Oklahoma, 73104

  • Oklahoma Foundation for Cardiovascular Research

    Oklahoma City, Oklahoma, 73120

  • The Cardiac Center of Creighton University

    Omaha, Nebraska, 68131

  • Florida Hospital

    Orlando, Florida, 32804

  • Orlando Regional Medical Center

    Orlando, Florida, 32806

  • Palm Beach Gardens Research Center

    Palm Beach Gardens, Florida, 33410

  • St. Joseph Regional Medical Center

    Paterson, New Jersey, 07503

  • Cardiovascular Consultants

    Phoenix, Arizona, 85032

  • Pinehurst Medical Clinic, Inc.

    Pinehurst, North Carolina, 28374

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Black Hills Cardiovascular Research

    Rapid City, South Dakota, 57701

  • Carolina Cardiology Associates

    Rock Hill, South Carolina, 29732

  • Sanford Cardiology

    Sanford, North Carolina, 27330

  • Velella Research

    Sarasota, Florida, 34233

  • Baystate Cardiology

    Springfield, Massachusetts, 01199

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Tallahassee Research Institute, Inc.

    Tallahassee, Florida, 32308

  • Northwest Ohio Cardiology Consultants/The Toledo Hospital

    Toledo, Ohio, 43615

  • St. Elizabeth Medical Center - Hotvedt

    Utica, New York, 13501

  • Cardiovascular Associates Virginia Beach

    Virginia Beach, Virginia, 23454

  • Providence Health Center

    Waco, Texas, 76712

  • Iowa Heart Center

    West Des Moines, Iowa, 50266

  • Cardiology Associates of Palm Beach - West Palm Beach

    West Palm Beach, Florida, 33401

  • Wake Forest

    Winston-Salem, North Carolina, 27157

  • Michigan Heart

    Ypsilanti, Michigan, 48197

Other trials in United States

Canada3 sites

  • University of Alberta

    Edmonton, Alberta, T6G 2B7

  • Mississauga Clinical Research Centre

    Mississauga, Ontario, L5B 2P7

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Puerto Rico1 site

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

    Rio Piedras, 00924

Other trials in Puerto Rico

About this study

Official title: PRE-DETERMINE: Biologic Markers and MRI SCD Cohort Study

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.

Read the 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.

Keywords
Coronary Artery Disease, Sudden Cardiac Death, Myocardial Infarction, Percutaneous Coronary Intervention, Implantable Cardiac Defibrillator
Medical subject headings
Coronary Artery Disease, Ventricular Dysfunction, Left, Death, Sudden, Cardiac, Myocardial Infarction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sudden and/or arrhythmic cardiac death or resuscitated ventricular fibrillation.

    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.

    Measured: Median follow-up estimated to be 10.7 years

Secondary outcomes (5)

  1. ICD Shock

    ICD therapies for ventricular arrhythmias over 200 BPMs will be added to the endpoint.

    Measured: Median follow-up estimated to be 10.7 years

  2. ICD Implantation

    Measured: Median follow-up estimated to be 10.7 years

  3. Total Cardiac Mortality

    Measured: Median follow-up estimated to be 10.7 years

  4. Total Mortality

    Measured: Median follow-up estimated to be 10.7 years

  5. Non-Sudden or Arrhythmic Causes of Mortality

    Competing causes of mortality in competing risk analyses.

    Measured: Median follow-up estimated to be 10.7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2010 (estimated)
  2. Study startJul 2007
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,764 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01114269
Sponsor's protocol ID
2007P000840
Other IDs
R01HL091069, R01HL165840
Status last verified
Oct 2025
First submitted
29 Apr 2010
Last updated
7 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chatterjee NA, Moorthy MV, Pester J, Schaecter A, Panicker GK, Narula D, Lee DC, Goldberger JJ, Kadish A, Cook NR, Albert CM; PRE-DETERMINE Study Group. Sudden Death in Patients With Coronary Heart Disease Without Severe Systolic Dysfunction. JAMA Cardiol. 2018 Jul 1;3(7):591-600. doi: 10.1001/jamacardio.2018.1049.

    PubMed 29801082

  • Lee DC, Albert CM, Narula D, Kadish AH, Panicker GK, Wu E, Schaechter A, Pester J, Chatterjee NA, Cook NR, Goldberger JJ. Estimating Myocardial Infarction Size With a Simple Electrocardiographic Marker Score. J Am Heart Assoc. 2020 Feb 4;9(3):e014205. doi: 10.1161/JAHA.119.014205. Epub 2020 Jan 24.

    PubMed 31973600

  • Chatterjee NA, Tikkanen JT, Panicker GK, Narula D, Lee DC, Kentta T, Junttila JM, Cook NR, Kadish A, Goldberger JJ, Huikuri HV, Albert CM; PREDETERMINE Investigators. Simple electrocardiographic measures improve sudden arrhythmic death prediction in coronary disease. Eur Heart J. 2020 Jun 1;41(21):1988-1999. doi: 10.1093/eurheartj/ehaa177.

    PubMed 32259257

  • Silverman MG, Yeri A, Moorthy MV, Camacho Garcia F, Chatterjee NA, Glinge CSA, Tfelt-Hansen J, Salvador AM, Pico AR, Shah R, Albert CM, Das S. Circulating miRNAs and Risk of Sudden Death in Patients With Coronary Heart Disease. JACC Clin Electrophysiol. 2020 Jan;6(1):70-79. doi: 10.1016/j.jacep.2019.08.011. Epub 2019 Oct 30.

    PubMed 31971908

  • Sandhu RK, Dron JS, Liu Y, Moorthy MV, Chatterjee NA, Ellinor PT, Chasman DI, Cook NR, Khera AV, Albert CM. Polygenic Risk Score Predicts Sudden Death in Patients With Coronary Disease and Preserved Systolic Function. J Am Coll Cardiol. 2022 Aug 30;80(9):873-883. doi: 10.1016/j.jacc.2022.05.049.

    PubMed 36007985

  • Peek N, Hindricks G, Akbarov A, Tijssen JGP, Jenkins DA, Kapacee Z, Parkes LM, van der Geest RJ, Longato E, Sprague D, Taleb Y, Ong M, Miller CA, Shamloo AS, Albert C, Barthel P, Boveda S, Braunschweig F, Johansen JB, Cook N, de Chillou C, Elders P, Faxen J, Friede T, Fusini L, Gale CP, Jarkovsky J, Jouven X, Junttila J, Kautzner J, Kiviniemi A, Kutyifa V, Leclercq C, Lee DC, Leigh J, Lenarczyk R, Leyva F, Maeng M, Manca A, Marijon E, Marschall U, Merino JL, Mont L, Nielsen JC, Olsen T, Pester J, Pontone G, Roca I, Schmidt G, Schwartz PJ, Sticherling C, Suleiman M, Taborsky M, Tan HL, Tfelt-Hansen J, Thiele H, Tomaselli GF, Verstraelen T, Vinayagamoorthy M, Olesen KKW, Wilde A, Willems R, Wu KC, Zabel M, Martin GP, Dagres N. Sudden cardiac death after myocardial infarction: individual participant data from pooled cohorts. Eur Heart J. 2024 Nov 14;45(43):4616-4626. doi: 10.1093/eurheartj/ehae326.

    PubMed 39378245

  • Panicker GK, Narula DD, Albert CM, Lee DC, Kothari S, Goldberger JJ, Cook N, Schaechter A, Kim E, Moorthy MV, Pester J, Chatterjee NA, Kadish AH, Karnad DR. Validation of electrocardiographic criteria for identifying left ventricular dysfunction in patients with previous myocardial infarction. Ann Noninvasive Electrocardiol. 2021 Mar;26(2):e12812. doi: 10.1111/anec.12812. Epub 2020 Oct 30.

    PubMed 33124739

  • Venkateswaran RV, Moorthy MV, Chatterjee NA, Pester J, Kadish AH, Lee DC, Cook NR, Albert CM. Diabetes and Risk of Sudden Death in Coronary Artery Disease Patients Without Severe Systolic Dysfunction. JACC Clin Electrophysiol. 2021 Dec;7(12):1604-1614. doi: 10.1016/j.jacep.2021.05.014. Epub 2021 Jul 28.

    PubMed 34332876

  • Adabag S, Patton KK, Buxton AE, Rector TS, Ensrud KE, Vakil K, Levy WC, Poole JE. Association of Implantable Cardioverter Defibrillators With Survival in Patients With and Without Improved Ejection Fraction: Secondary Analysis of the Sudden Cardiac Death in Heart Failure Trial. JAMA Cardiol. 2017 Jul 1;2(7):767-774. doi: 10.1001/jamacardio.2017.1413.

    PubMed 28724134

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Left Ventricular Dysfunction, run by Brigham and Women's Hospital at 90 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sudden and/or arrhythmic cardiac death or resuscitated ventricular fibrillation. (time frame: Median follow-up estimated to be 10.7 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01114269, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.

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PRE-DETERMINE Cohort Study (NCT01114269) | AzTrials