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PRE-DETERMINE Cohort Study

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01114269
First Posted: May 3, 2010
Last Update Posted: June 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
St. Jude Medical
Northwestern University
Roche Diagnostics
Quintiles, Inc.
Information provided by (Responsible Party):
Christine M. Albert, MD, MPH, Brigham and Women's Hospital
  Purpose
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.

Condition
Coronary Artery Disease Left Ventricular Dysfunction Sudden Cardiac Death

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PRE-DETERMINE: Biologic Markers and MRI SCD Cohort Study

Further study details as provided by Christine M. Albert, MD, MPH, Brigham and Women's Hospital:

Primary Outcome Measures:
  • Sudden and/or arrhythmic cardiac death or resuscitated ventricular fibrillation. [ Time Frame: Median follow-up estimated to be 8 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.


Secondary Outcome Measures:
  • ICD Shock [ Time Frame: Median follow-up estimated to be 8 years ]
    ICD therapies for ventricular arrhythmias over 200 BPMs will be added to the endpoint.

  • ICD Implantation [ Time Frame: Median follow-up estimated to be 8 years ]
  • Total Cardiac Mortality [ Time Frame: Median follow-up estimated to be 8 years ]
  • Total Mortality [ Time Frame: Median follow-up estimated to be 8 years ]
  • Non-Sudden or Arrhythmic Causes of Mortality [ Time Frame: Median follow-up estimated to be 8 years ]
    Competing causes of mortality in competing risk analyses.


Biospecimen Retention:   Samples With DNA
plasma, buffy coat, and red blood cells

Enrollment: 5764
Study Start Date: June 2007
Estimated Study Completion Date: February 2021
Estimated Primary Completion Date: February 2021 (Final data collection date for primary outcome measure)
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 136 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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01114269


  Hide Study Locations
Locations
United States, Alaska
Alaska Heart Institute
Anchorage, Alaska, United States, 99508
United States, Arizona
Phoenix Heart, PLLC
Glendale, Arizona, United States, 85306
Cardiovascular Consultants
Phoenix, Arizona, United States, 85032
United States, California
Beaver Medical Group/Clinical Care Research
Banning, California, United States, 92220
United States, Colorado
Memorial Health System
Colorado Springs, Colorado, United States, 80909
Colorado Heart and Vascular
Denver, Colorado, United States, 80204
United States, Florida
Bay Area Cardiology Associates, P.A.
Brandon, Florida, United States, 33511
University of Florida - Gainsville
Gainesville, Florida, United States, 32610
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Reliable Clinical Research
Miami, Florida, United States, 33135
Florida Hospital
Orlando, Florida, United States, 32804
Orlando Regional Medical Center
Orlando, Florida, United States, 32806
Palm Beach Gardens Research Center
Palm Beach Gardens, Florida, United States, 33410
Velella Research
Sarasota, Florida, United States, 34233
Tallahassee Research Institute, Inc.
Tallahassee, Florida, United States, 32308
Cardiology Associates of Palm Beach - West Palm Beach
West Palm Beach, Florida, United States, 33401
United States, Georgia
Georgia Heart Specialist
Covington, Georgia, United States, 30014
Northeast Georgia Heart Center, P.C.
Gainesville, Georgia, United States, 30501
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Advocate Medical Group
Chicago, Illinois, United States, 60643
Advocate Medical Group - Heart and Vascular of IL
Chicago, Illinois, United States, 60657
Consultants in Cardiovascular Medicine
Melrose Park, Illinois, United States, 60160
United States, Indiana
Community Heart and Vascular
Anderson, Indiana, United States, 46011
United States, Iowa
Iowa Heart Center
West Des Moines, Iowa, United States, 50266
United States, Kansas
The University of Kansas
Kansas City, Kansas, United States, 66160
United States, Kentucky
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
United States, Louisiana
Leonard J. Chabert Medical Center
Houma, Louisiana, United States, 70363
United States, Maine
Maine Research Associates
Auburn, Maine, United States, 04210
Maine Research Associates - Lewiston
Lewiston, Maine, United States, 04240
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Primary Care Cardiology Research
Ayer, Massachusetts, United States, 01432
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
NECCR Internal Medicine and Cardiology Associates, LLC
Fall River, Massachusetts, United States, 02720
Hawthorn Medical Associates
North Dartmouth, Massachusetts, United States, 02747
Baystate Cardiology
Springfield, Massachusetts, United States, 01199
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
Oakwood Hospital & Medical Center
Dearborn, Michigan, United States, 48124
McLaren Medical Center - Macomb
Mount Clemens, Michigan, United States, 48043
Michigan Heart
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States, 55417
United States, Missouri
University of Missouri Health Care
Columbia, Missouri, United States, 65201
United States, Montana
Glacier View Cardiology
Kalispell, Montana, United States, 59901
United States, Nebraska
The Cardiac Center of Creighton University
Omaha, Nebraska, United States, 68131
United States, New Jersey
Advanced Heartcare, LLC
Bridgewater, New Jersey, United States, 08807
St. Joseph Regional Medical Center
Paterson, New Jersey, United States, 07503
United States, New Mexico
New Mexico VA Healthcare Systems
Albuquerque, New Mexico, United States, 87108
United States, New York
Albany Associates Cardiology
Albany, New York, United States, 12205
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Buffalo General Hospital/Kaleida Health
Buffalo, New York, United States, 14203
Jamaica Hospital Medical Center
Jamaica, New York, United States, 11418
Mid-Valley Cardiology
Kingston, New York, United States, 12401
Winthrop-University Hospital
Mineola, New York, United States, 11501
Gotham Cardiovascular
New York, New York, United States, 10001
Columbia University Health Center
New York, New York, United States, 10032
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
St. Elizabeth Medical Center - Hotvedt
Utica, New York, United States, 13501
United States, North Carolina
Asheville Cardiology Associates
Asheville, North Carolina, United States, 28801
Eastern Carolina Cardiovascular
Elizabeth City, North Carolina, United States, 27909
Northstate Clinical Research
Lenoir, North Carolina, United States, 28645
Pinehurst Medical Clinic, Inc.
Pinehurst, North Carolina, United States, 28374
Sanford Cardiology
Sanford, North Carolina, United States, 27330
Wake Forest
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Northeast Ohio Cardiovascular Specialists
Akron, Ohio, United States, 44304
University of Cincinnati
Cincinnati, Ohio, United States, 45267
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
North Ohio Research, Ltd.
Elyria, Ohio, United States, 44035
Mercy Medical Associates
Fairfield, Ohio, United States, 45014
Northwest Ohio Cardiology Consultants/The Toledo Hospital
Toledo, Ohio, United States, 43615
United States, Oklahoma
Oklahoma City VA Medical Center Veterans Research and Education Foundation
Oklahoma City, Oklahoma, United States, 73104
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, United States, 73120
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
St. Luke's Bethlehem
Bethlehem, Pennsylvania, United States, 18018
Doylestown Cardiology Associates
Doylestown, Pennsylvania, United States, 18901
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
AnMed Health
Anderson, South Carolina, United States, 29621
VA Medical Center - Charleston
Charleston, South Carolina, United States, 29425
Carolina Cardiology Associates
Rock Hill, South Carolina, United States, 29732
United States, South Dakota
Black Hills Cardiovascular Research
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Cardiovasular Research of Knoxville
Knoxville, Tennessee, United States, 37917
Memphis VA Medical Center
Memphis, Tennessee, United States, 38104
United States, Texas
St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030
Non-Invasive Cardiovascular PA
Houston, Texas, United States, 77074
Providence Health Center
Waco, Texas, United States, 76712
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157
United States, Virginia
Cardiovascular Associates Virginia Beach
Virginia Beach, Virginia, United States, 23454
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Mississauga Clinical Research Centre
Mississauga, Ontario, Canada, L5B 2P7
Puerto Rico
Transcatheter Medical, Inc. Centro Cardiovascular de Caguas y del Caribe
Rio Piedras, Puerto Rico, 00924
Sponsors and Collaborators
Brigham and Women's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
St. Jude Medical
Northwestern University
Roche Diagnostics
Quintiles, Inc.
Investigators
Principal Investigator: Christine M Albert, MD, MPH Brigham and Women's Hospital
  More Information

Additional Information:
Responsible Party: Christine M. Albert, MD, MPH, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01114269     History of Changes
Other Study ID Numbers: 2007-P-000840, 3041108
R01HL091069 ( U.S. NIH Grant/Contract )
First Submitted: April 29, 2010
First Posted: May 3, 2010
Last Update Posted: June 5, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Christine M. Albert, MD, MPH, Brigham and Women's Hospital:
Coronary Artery Disease
Sudden Cardiac Death
Myocardial Infarction
Percutaneous Coronary Intervention
Implantable Cardiac Defibrillator

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ventricular Dysfunction
Death
Death, Sudden, Cardiac
Ventricular Dysfunction, Left
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Heart Arrest
Death, Sudden