PRE-DETERMINE Cohort Study
PRE-DETERMINE: Biologic Markers and MRI SCD Cohort Study
3 other identifiers
observational
5,764
3 countries
90
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2007
Longer than P75 for all trials
90 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 29, 2010
CompletedFirst Posted
Study publicly available on registry
May 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
October 7, 2025
October 1, 2025
19.4 years
April 29, 2010
October 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Median follow-up estimated to be 10.7 years
Secondary Outcomes (5)
ICD Shock
Median follow-up estimated to be 10.7 years
ICD Implantation
Median follow-up estimated to be 10.7 years
Total Cardiac Mortality
Median follow-up estimated to be 10.7 years
Total Mortality
Median follow-up estimated to be 10.7 years
Non-Sudden or Arrhythmic Causes of Mortality
Median follow-up estimated to be 10.7 years
Eligibility Criteria
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.
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
- +1 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brigham and Women's Hospitallead
- Abbott Medical Devicescollaborator
- Northwestern Universitycollaborator
- Quintiles, Inc.collaborator
- Roche Diagnostic Ltd.collaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Cedars-Sinai Medical Centercollaborator
Study Sites (90)
Alaska Heart Institute
Anchorage, Alaska, 99508, United States
Phoenix Heart, PLLC
Glendale, Arizona, 85306, United States
Cardiovascular Consultants
Phoenix, Arizona, 85032, United States
Beaver Medical Group/Clinical Care Research
Banning, California, 92220, United States
Memorial Health System
Colorado Springs, Colorado, 80909, United States
Colorado Heart and Vascular
Denver, Colorado, 80204, United States
Bay Area Cardiology Associates, P.A.
Brandon, Florida, 33511, United States
University of Florida - Gainsville
Gainesville, Florida, 32610, United States
Reliable Clinical Research
Miami, Florida, 33135, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Florida Hospital
Orlando, Florida, 32804, United States
Orlando Regional Medical Center
Orlando, Florida, 32806, United States
Palm Beach Gardens Research Center
Palm Beach Gardens, Florida, 33410, United States
Velella Research
Sarasota, Florida, 34233, United States
Tallahassee Research Institute, Inc.
Tallahassee, Florida, 32308, United States
Cardiology Associates of Palm Beach - West Palm Beach
West Palm Beach, Florida, 33401, United States
Georgia Heart Specialist
Covington, Georgia, 30014, United States
Northeast Georgia Heart Center, P.C.
Gainesville, Georgia, 30501, United States
University of Chicago
Chicago, Illinois, 60637, United States
Advocate Medical Group
Chicago, Illinois, 60643, United States
Advocate Medical Group - Heart and Vascular of IL
Chicago, Illinois, 60657, United States
Consultants in Cardiovascular Medicine
Melrose Park, Illinois, 60160, United States
Community Heart and Vascular
Anderson, Indiana, 46011, United States
Iowa Heart Center
West Des Moines, Iowa, 50266, United States
The University of Kansas
Kansas City, Kansas, 66160, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
Leonard J. Chabert Medical Center
Houma, Louisiana, 70363, United States
Maine Research Associates
Auburn, Maine, 04210, United States
Maine Research Associates - Lewiston
Lewiston, Maine, 04240, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Primary Care Cardiology Research
Ayer, Massachusetts, 01432, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
NECCR Internal Medicine and Cardiology Associates, LLC
Fall River, Massachusetts, 02720, United States
Hawthorn Medical Associates
North Dartmouth, Massachusetts, 02747, United States
Baystate Cardiology
Springfield, Massachusetts, 01199, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
Oakwood Hospital & Medical Center
Dearborn, Michigan, 48124, United States
McLaren Medical Center - Macomb
Mount Clemens, Michigan, 48043, United States
Michigan Heart
Ypsilanti, Michigan, 48197, United States
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417, United States
University of Missouri Health Care
Columbia, Missouri, 65201, United States
Glacier View Cardiology
Kalispell, Montana, 59901, United States
The Cardiac Center of Creighton University
Omaha, Nebraska, 68131, United States
Advanced Heartcare, LLC
Bridgewater, New Jersey, 08807, United States
St. Joseph Regional Medical Center
Paterson, New Jersey, 07503, United States
New Mexico VA Healthcare Systems
Albuquerque, New Mexico, 87108, United States
Albany Associates Cardiology
Albany, New York, 12205, United States
Maimonides Medical Center
Brooklyn, New York, 11219, United States
Buffalo General Hospital/Kaleida Health
Buffalo, New York, 14203, United States
Jamaica Hospital Medical Center
Jamaica, New York, 11418, United States
Mid-Valley Cardiology
Kingston, New York, 12401, United States
Winthrop-University Hospital
Mineola, New York, 11501, United States
Gotham Cardiovascular
New York, New York, 10001, United States
Columbia University Health Center
New York, New York, 10032, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
St. Elizabeth Medical Center - Hotvedt
Utica, New York, 13501, United States
Asheville Cardiology Associates
Asheville, North Carolina, 28801, United States
Eastern Carolina Cardiovascular
Elizabeth City, North Carolina, 27909, United States
Northstate Clinical Research
Lenoir, North Carolina, 28645, United States
Pinehurst Medical Clinic, Inc.
Pinehurst, North Carolina, 28374, United States
Sanford Cardiology
Sanford, North Carolina, 27330, United States
Wake Forest
Winston-Salem, North Carolina, 27157, United States
Northeast Ohio Cardiovascular Specialists
Akron, Ohio, 44304, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
North Ohio Research, Ltd.
Elyria, Ohio, 44035, United States
Mercy Medical Associates
Fairfield, Ohio, 45014, United States
Northwest Ohio Cardiology Consultants/The Toledo Hospital
Toledo, Ohio, 43615, 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
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
St. Luke's Bethlehem
Bethlehem, Pennsylvania, 18018, United States
Doylestown Cardiology Associates
Doylestown, Pennsylvania, 18901, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
AnMed Health
Anderson, South Carolina, 29621, United States
VA Medical Center - Charleston
Charleston, South Carolina, 29425, United States
Carolina Cardiology Associates
Rock Hill, South Carolina, 29732, United States
Black Hills Cardiovascular Research
Rapid City, South Dakota, 57701, United States
Cardiovasular Research of Knoxville
Knoxville, Tennessee, 37917, United States
Memphis VA Medical Center
Memphis, Tennessee, 38104, United States
St. Luke's Episcopal Hospital
Houston, Texas, 77030, United States
Non-Invasive Cardiovascular PA
Houston, Texas, 77074, United States
Providence Health Center
Waco, Texas, 76712, United States
Intermountain Medical Center
Murray, Utah, 84157, United States
Cardiovascular Associates Virginia Beach
Virginia Beach, Virginia, 23454, United States
University of Alberta
Edmonton, Alberta, T6G 2B7, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Mississauga Clinical Research Centre
Mississauga, Ontario, L5B 2P7, Canada
Transcatheter Medical, Inc. Centro Cardiovascular de Caguas y del Caribe
Rio Piedras, 00924, Puerto Rico
Related Publications (10)
Krieglstein GK, Schrems W. [Stereospecificity of beta-blocker effects on the glaucomatous eye]. Fortschr Ophthalmol. 1984;81(2):127-9. No abstract available. German.
PMID: 6145665RESULTFriedlander MH, Werblin TP, Kaufman HE, Granet NS. Clinical results of keratophakia and keratomileusis. Ophthalmology. 1981 Aug;88(8):716-20. doi: 10.1016/s0161-6420(81)34957-4.
PMID: 7033860RESULTWeisgraber KH, Rall SC Jr, Mahley RW. Human E apoprotein heterogeneity. Cysteine-arginine interchanges in the amino acid sequence of the apo-E isoforms. J Biol Chem. 1981 Sep 10;256(17):9077-83. No abstract available.
PMID: 7263700RESULTChao FC, Tullis JL, Alper CA, Glynn RJ, Silbert JE. Alteration in plasma proteins and platelet functions with aging and cigarette smoking in healthy men. Thromb Haemost. 1982 Jun 28;47(3):259-64.
PMID: 6981228RESULTSandhu 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.
PMID: 36007985RESULTPeek 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.
PMID: 39378245RESULTPanicker 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.
PMID: 33124739RESULTVenkateswaran 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.
PMID: 34332876RESULTChatterjee 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.
PMID: 32259257DERIVEDAdabag 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.
PMID: 28724134DERIVED
Related Links
Biospecimen
plasma, buffy coat, and red blood cells
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christine M Albert, M.D., M.P.H.
Brigham and Women's Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 29, 2010
First Posted
May 3, 2010
Study Start
July 1, 2007
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
October 7, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share