๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-10-02

PRE-DETERMINE Cohort Study (NCT01114269)

PRE-DETERMINE: Biologic Markers and MRI SCD Cohort Study

๐Ÿ”ต Active, Not Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: Brigham and Women's Hospital

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Alaska Heart Institute โ€” Anchorage, Alaska

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (90 Sites)

Showing the first 25 of 90 sites.

  • Alaska Heart Institute โ€” Anchorage, Alaska
  • Phoenix Heart, PLLC โ€” Glendale, Arizona
  • Cardiovascular Consultants โ€” Phoenix, Arizona
  • Beaver Medical Group/Clinical Care Research โ€” Banning, California
  • Memorial Health System โ€” Colorado Springs, Colorado
  • Colorado Heart and Vascular โ€” Denver, Colorado
  • Bay Area Cardiology Associates, P.A. โ€” Brandon, Florida
  • University of Florida - Gainsville โ€” Gainesville, Florida
  • Reliable Clinical Research โ€” Miami, Florida
  • Mount Sinai Medical Center โ€” Miami Beach, Florida
  • Florida Hospital โ€” Orlando, Florida
  • Orlando Regional Medical Center โ€” Orlando, Florida
  • Palm Beach Gardens Research Center โ€” Palm Beach Gardens, Florida
  • Velella Research โ€” Sarasota, Florida
  • Tallahassee Research Institute, Inc. โ€” Tallahassee, Florida
  • Cardiology Associates of Palm Beach - West Palm Beach โ€” West Palm Beach, Florida
  • Georgia Heart Specialist โ€” Covington, Georgia
  • Northeast Georgia Heart Center, P.C. โ€” Gainesville, Georgia
  • University of Chicago โ€” Chicago, Illinois
  • Advocate Medical Group โ€” Chicago, Illinois
  • Advocate Medical Group - Heart and Vascular of IL โ€” Chicago, Illinois
  • Consultants in Cardiovascular Medicine โ€” Melrose Park, Illinois
  • Community Heart and Vascular โ€” Anderson, Indiana
  • Iowa Heart Center โ€” West Des Moines, Iowa
  • The University of Kansas โ€” Kansas City, Kansas

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—