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PRE-DETERMINE Cohort Study
NCT01114269 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Study Locations (20)
Florida
- Bay Area Cardiology Associates, P.A. — Brandon
- University of Florida - Gainsville — Gainesville
- Reliable Clinical Research — Miami
- Mount Sinai Medical Center — Miami Beach
- Florida Hospital — Orlando
- Orlando Regional Medical Center — Orlando
- Palm Beach Gardens Research Center — Palm Beach Gardens
- Velella Research — Sarasota
- Tallahassee Research Institute, Inc. — Tallahassee
- Cardiology Associates of Palm Beach - West Palm Beach — West Palm Beach
Arizona
- Phoenix Heart, PLLC — Glendale
- Cardiovascular Consultants — Phoenix
Colorado
- Memorial Health System — Colorado Springs
- Colorado Heart and Vascular — Denver
Georgia
- Georgia Heart Specialist — Covington
- Northeast Georgia Heart Center, P.C. — Gainesville
Illinois
- University of Chicago — Chicago
- Advocate Medical Group — Chicago
Alaska
- Alaska Heart Institute — Anchorage
California
- Beaver Medical Group/Clinical Care Research — Banning
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,764 participants |
| Start Date | 2007-07 |
| Est. Completion | 2026-11 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01114269
The ClinicalTrials.gov registry entry for NCT01114269 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 5,764 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 929 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01114269 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, Arizona, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01114269 about?
NCT01114269 is a clinical study titled "PRE-DETERMINE 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 biol...
What is the current status of trial NCT01114269?
This trial is currently active not recruiting. The enrollment target is 5,764 participants. The study started on 2007-07. Estimated completion is 2026-11.
What conditions does trial NCT01114269 study?
This clinical trial studies the following conditions: Coronary Artery Disease, Sudden Cardiac Death, Left Ventricular Dysfunction. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT01114269?
This trial is sponsored by Brigham and Women's Hospital, which has 929 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01114269 being conducted?
This trial has 20 study locations across Alaska, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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