🏛️ Verified NIH Record • Updated 2026-08-07

A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial) (NCT07286578)

A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Fundación EPIC

🩺 Plain-English Summary (8th-Grade Level)

The OPTIMAL randomized clinical trial has been designed to compare two imaging strategies and to test the hypothesis that a calcium modification strategy informed by coronary CT angiography (CCTA) will improve procedural efficiency and effectiveness compared with the current standard of care (IVUS-guided PCI) while achieving similar clinical outcomes in patients with hemodynamically significant calcified coronary artery disease.

Who can join: Review the eligibility criteria below.

Location: Bringham and Women's Hospital — Boston, Massachusetts

Age range: 18 Years to 85 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (14 Sites)

  • Bringham and Women's Hospital — Boston, Massachusetts
  • Minneapolis Heart Institute — Minneapolis, Minnesota
  • HACKENSACK MERIDIAN HEALTH, Inc — Jersey City, New Jersey
  • Columbia University Irving Medical Center/NewYork-Presbyterian Hospital — New York, New York
  • Weill Medical College of Cornell University — New York, New York
  • Azorg Hospital, Aalst — Aalst,
  • Hospital Universitari Vall Hebron — Barcelona,
  • Hospital Universitario de Leon — León,
  • Hospital Universitario La Paz — Madrid,
  • University Hospitals of Leicester NHS Trust — Leicester,
  • St Bartholomew's Hospital (Barts Health NHS Trust) — London,
  • St George's University Hospitals NHS Foundations Trust — London,
  • Newcastle Hospitals NHS Foundations Trust — Newcastle,
  • John Radcliffe Hospital, Oxford — Oxford,

📞 Contact the Study Coordinator

Phone: 001 917 753 6695

Email: cfocella@crf.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 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 § 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.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  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.
🏛️ View Official NIH Record ↗