PRE-DETERMINE Cohort Study



Status:Active, not recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:5/19/2018
Start Date:June 2007
End Date:February 2021

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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.

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.

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
We found this trial at
87
sites
601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Florida Hospital Florida Hospital is one of the country
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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1414 Kuhl Avenue
Orlando, Florida 32806
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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Albany, New York 12212
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Albuquerque, New Mexico 87108
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Anderson, Indiana 46011
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Anderson, South Carolina 29621
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Ann Arbor, Michigan 48109
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Asheville, North Carolina 28802
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Auburn, Maine 04210
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Ayer, Massachusetts 01432
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
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Bethlehem, Pennsylvania 18018
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Brandon, Florida 33511
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Bridgewater, New Jersey 08807
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4802 10th Ave
Brooklyn, New York 11219
(718) 283-6000
Maimonides Medical Center At 103 years old, Maimonides Medical Center remains a vital and thriving...
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Buffalo, New York 14203
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Charleston, South Carolina 29425
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Chicago, Illinois 60643
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
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Colorado Springs, Colorado 80909
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Columbia, Missouri 65203
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Covington, Georgia 30014
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Dearborn, Michigan 48123
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Denver, Colorado 80204
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Doylestown, Pennsylvania 18901
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Edmonton, Alberta T6G 2J2
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Elizabeth City, North Carolina 27909
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Elyria, Ohio 44035
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Jamaica, New York 11418
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Kalispell, Montana 59901
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Kingston, New York 12401
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Knoxville, Tennessee 37917
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Lenoir, North Carolina 28645
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Lewiston, Maine 04240
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Lexington, Kentucky 40503
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Melrose Park, Illinois 60160
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Memphis, Tennessee 38104
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Miami, Florida 33135
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Miami Beach, Florida 33140
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259 1st St
Mineola, New York 11501
(516) 663-0333
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Minneapolis, Minnesota 55417
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1000 Harrington St
Mount Clemens, Michigan 48043
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5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
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New York, New York 10001
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New York, New York 10032
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North Dartmouth, Massachusetts 02747
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Oklahoma City, Oklahoma 73210
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Palm Beach Gardens, Florida 33410
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Paterson, New Jersey 07503
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Phoenix, Arizona 85032
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Pinehurst, North Carolina 28734
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
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Rapid City, South Dakota 57701
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Sanford, North Carolina 27330
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Sarasota, Florida 34233
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Springfield, Massachusetts 01199
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101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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Tallahassee, Florida 32308
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Virginia Beach, Virginia 23454
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Waco, Texas 76712
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Ypsilanti, Michigan 48197
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