PRE-DETERMINE Cohort Study

This study is currently recruiting participants.
Verified August 2013 by Brigham and Women's Hospital
Sponsor:
Collaborators:
St. Jude Medical
Northwestern University
Information provided by (Responsible Party):
Christine M. Albert, MD, MPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01114269
First received: April 29, 2010
Last updated: August 13, 2013
Last verified: August 2013
  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 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> 35%). In addition, we will also address whether these promising genetic markers and biomarkers advance sudden cardiac death (SCD) risk prediction when combined with advanced substrate imaging by participants that have undergone a CE-MRI at baseline.


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

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • To identify a series of genetic markers and biomarkers that specifically predict risk of arrhythmic death as compared to other causes of mortality among CAD patients with preserved left ventricular ejection fraction (LVEF > 35%). [ Time Frame: Once an adequate number of sudden arrhythmic events (~n=400) has accrued a nested case-cohort design will be utilized to test for associations between biomarkers and sudden arrhythmic events. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine whether these genetic markers and biomarkers advance SCD risk prediction when combined with advanced substrate imaging by CE-MRI. [ Time Frame: Once an adequate number of sudden arrhythmic events (~n=400) has accrued a nested case-cohort design will be utilized to test for associations between genetic variants and sudden arrhythmic events. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

plasma, buffy coat, and red blood cells


Estimated Enrollment: 5800
Study Start Date: June 2007
Estimated Study Completion Date: December 2015
Detailed Description:

There are an estimated 250,000-400,000 sudden cardiac deaths (SCD) annually in the United States constituting approximately 50% of all cardiac deaths. Although clinical trials have demonstrated convincing survival benefits conferred by implantable cardioverter defibrillator (ICD) therapy in selected patients with left ventricular ejection fractions (LVEF) less than 35% and congestive heart failure, the overwhelming majority of patients who suffer a cardiac arrest will have an LVEF> 0.35. The PRE-DETERMINE: Biologic Markers and MRI SCD Cohort Study seeks to identify patients at a substantially higher risk of arrhythmic death among coronary heart disease (CHD) patients with preserved left ventricular ejection fractions (LVEF>35%). If biomarkers or genetic 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.

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 will be enrolled at about 100 sites where information on baseline demographic, clinical characteristics, pertinent past medical history, lifestyle habits, and medications will be collected. Electrocardiograms along with a blood sample will also be collected at baseline, sent to central laboratories, and stored for future analyses. The participants contact information will be collected and stored in a secure database and all participants will be followed centrally on a 6-month basis via mail/phone to document interim non-fatal arrhythmic events and cause-specific mortality. Study endpoints will be confirmed through review of medical records, interviews with next-of-kin, death certificates, and autopsy reports, if available.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Participants will be recruited throughout multicenter sites, which are participating in the PRE-DETERMINE Cohort Study. We plan to enroll 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%). The clinical study staff at each site, which may be a research nurse, fellow, or physician will approach 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-III 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01114269

Contacts
Contact: Julie A Pester, BA 617-278-0862 jpester@partners.org

  Hide Study Locations
Locations
United States, Alaska
Alaska Heart Institute Recruiting
Anchorage, Alaska, United States, 99508
United States, Arizona
Phoenix Heart, PLLC Recruiting
Glendale, Arizona, United States, 85306
Cardiovascular Consultants Recruiting
Phoenix, Arizona, United States, 85032
United States, California
Beaver Medical Group/Clinical Care Research Recruiting
Banning, California, United States, 92220
United States, Colorado
Memorial Health System Recruiting
Colorado Springs, Colorado, United States, 80909
Colorado Heart and Vascular Recruiting
Denver, Colorado, United States, 80204
United States, Florida
Bay Area Cardiology Associates, P.A. Recruiting
Brandon, Florida, United States, 33511
University of Florida - Gainsville Recruiting
Gainesville, Florida, United States, 32610
University of Florida - Jacksonville Recruiting
Jacksonville, Florida, United States, 32209
Reliable Clinical Research Recruiting
Miami, Florida, United States, 33135
Florida Hospital Recruiting
Orlando, Florida, United States, 32804
Orlando Regional Medical Center Recruiting
Orlando, Florida, United States, 32806
Palm Beach Gardens Research Center Recruiting
Palm Beach Gardens, Florida, United States, 33410
Velella Research Recruiting
Sarasota, Florida, United States, 34233
Tallahassee Research Institute, Inc. Recruiting
Tallahassee, Florida, United States, 32308
United States, Georgia
Georgia Heart Specialist Recruiting
Covington, Georgia, United States, 30014
Northeast Georgia Heart Center, P.C. Recruiting
Gainesville, Georgia, United States, 30501
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Advocate Medical Group Recruiting
Chicago, Illinois, United States, 60643
Advocate Medical Group - Heart and Vascular of IL Recruiting
Chicago, Illinois, United States, 60657
Consultants in Cardiovascular Medicine Recruiting
Melrose Park, Illinois, United States, 60160
United States, Indiana
Community Heart and Vascular Recruiting
Anderson, Indiana, United States, 46011
United States, Iowa
Iowa Heart Center Recruiting
West Des Moines, Iowa, United States, 50266
United States, Kansas
The University of Kansas Recruiting
Kansas City, Kansas, United States, 66160
United States, Kentucky
Baptist Health Lexington Recruiting
Lexington, Kentucky, United States, 40503
United States, Louisiana
Leonard J. Chabert Medical Center Recruiting
Houma, Louisiana, United States, 70363
Interim LSU Public Hospital Recruiting
New Orleans, Louisiana, United States, 70112
United States, Maine
Maine Research Associates Recruiting
Auburn, Maine, United States, 04210
Maine Research Associates - Lewiston Recruiting
Lewiston, Maine, United States, 04240
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Primary Care Cardiology Research Recruiting
Ayer, Massachusetts, United States, 01432
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
NECCR Internal Medicine and Cardiology Associates, LLC Recruiting
Fall River, Massachusetts, United States, 02720
Hawthorn Medical Associates Recruiting
North Dartmouth, Massachusetts, United States, 02747
Baystate Cardiology Recruiting
Springfield, Massachusetts, United States, 01199
United States, Michigan
University of Michigan Medical Center Recruiting
Ann Arbor, Michigan, United States, 48109
Oakwood Hospital & Medical Center Recruiting
Dearborn, Michigan, United States, 48124
McLaren Medical Center - Macomb Recruiting
Mt. Clemens, Michigan, United States, 48043
Michigan Heart Recruiting
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
Minneapolis VA Medical Center Recruiting
Minneapolis, Minnesota, United States, 55417
United States, Missouri
University of Missouri Health Care Recruiting
Columbia, Missouri, United States, 65201
United States, Montana
Glacier View Cardiology Recruiting
Kalispell, Montana, United States, 59901
United States, Nebraska
The Cardiac Center of Creighton University Recruiting
Omaha, Nebraska, United States, 68131
United States, New Jersey
Advanced Heartcare, LLC Recruiting
Bridgewater, New Jersey, United States, 08807
St. Joseph Regional Medical Center Recruiting
Paterson, New Jersey, United States, 07503
Wayne Cardiology Recruiting
Wayne, New Jersey, United States, 07470
United States, New Mexico
New Mexico VA Healthcare Systems Recruiting
Albuquerque, New Mexico, United States, 87108
United States, New York
Albany Associates Cardiology Recruiting
Albany, New York, United States, 12205
East-West Research Inc. Recruiting
Brooklyn, New York, United States, 11216
Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11219
Buffalo General Hospital/Kaleida Health Recruiting
Buffalo, New York, United States, 14203
Jamaica Hospital Medical Center Recruiting
Jamaica, New York, United States, 11418
Mid-Valley Cardiology Recruiting
Kingston, New York, United States, 12401
Winthrop-University Hospital Recruiting
Mineola, New York, United States, 11501
Gotham Cardiovascular Recruiting
New York, New York, United States, 10001
Columbia University Health Center Recruiting
New York, New York, United States, 10032
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794
St. Elizabeth Medical Center - Hotvedt Recruiting
Utica, New York, United States, 13501
United States, North Carolina
Asheville Cardiology Associates Recruiting
Asheville, North Carolina, United States, 28801
Eastern Carolina Cardiovascular Recruiting
Elizabeth City, North Carolina, United States, 27909
Northstate Clinical Research Recruiting
Lenoir, North Carolina, United States, 28645
Pinehurst Medical Clinic, Inc. Recruiting
Pinehurst, North Carolina, United States, 28374
Sanford Cardiology Recruiting
Sanford, North Carolina, United States, 27330
Wake Forest Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Northeast Ohio Cardiovascular Specialists Recruiting
Akron, Ohio, United States, 44304
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
The MetroHealth System Recruiting
Cleveland, Ohio, United States, 44109
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
North Ohio Research, Ltd. Recruiting
Elyria, Ohio, United States, 44035
Mercy Medical Associates Recruiting
Fairfield, Ohio, United States, 45014
Northwest Ohio Cardiology Consultants/The Toledo Hospital Recruiting
Toledo, Ohio, United States, 43615
United States, Oklahoma
Oklahoma Foundation for Cardiovascular Research Recruiting
Oklahoma City, Oklahoma, United States, 73120
Oklahoma City VA Medical Center Veterans Research and Education Foundation Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
St. Luke's Bethlehem Recruiting
Bethlehem, Pennsylvania, United States, 18018
Doylestown Cardiology Associates Recruiting
Doylestown, Pennsylvania, United States, 18901
Lancaster Heart & Stroke Foundation Recruiting
Lancaster, Pennsylvania, United States, 17602
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
AnMed Health Recruiting
Anderson, South Carolina, United States, 29621
VA Medical Center - Charleston Recruiting
Charleston, South Carolina, United States, 29425
Carolina Cardiology Associates Recruiting
Rock Hill, South Carolina, United States, 29732
United States, South Dakota
Black Hills Cardiovascular Research Recruiting
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Cardiovasular Research of Knoxville Recruiting
Knoxville, Tennessee, United States, 37917
Stern Cardiovascular Foundation Recruiting
Memphis, Tennessee, United States, 38120
Memphis VA Medical Center Recruiting
Memphis, Tennessee, United States, 38104
United States, Texas
St. Luke's Episcopal Hospital Recruiting
Houston, Texas, United States, 77030
Non-Invasive Cardiovascular PA Recruiting
Houston, Texas, United States, 77074
Providence Health Center Recruiting
Waco, Texas, United States, 76712
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84157
United States, Virginia
Cardiovascular Associates Virginia Beach Recruiting
Virginia Beach, Virginia, United States, 23454
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Mississauga Clinical Research Centre Recruiting
Mississauga, Ontario, Canada, L5B 2P7
Puerto Rico
Mayaguez Medical Center Recruiting
Mayaguez, Puerto Rico, 00681
Transcatheter Medical, Inc. Centro Cardiovascular de Caguas y del Caribe Recruiting
Rio Piedras, Puerto Rico, 00924
Sponsors and Collaborators
Brigham and Women's Hospital
St. Jude Medical
Northwestern University
Investigators
Principal Investigator: Christine M Albert, MD, MPH Brigham and Women's Hospital
  More Information

Additional Information:
No publications provided

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
Study First Received: April 29, 2010
Last Updated: August 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Death
Death, Sudden, Cardiac
Ventricular Dysfunction, Left
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Heart Arrest
Death, Sudden

ClinicalTrials.gov processed this record on April 15, 2014