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)
🩺 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: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (22 items).
Location: Bringham and Women's Hospital — Boston, Massachusetts
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- STEMI as the clinical presentation.
- Uncontrolled or recurrent ventricular tachycardia.
- Hemodynamic instability.
- Hemodialysis or peritoneal dialysis.
- Left main coronary artery stenosis \> 50%
- Atrial fibrillation, flutter, or arrhythmias during CT acquisition.
- Previous PCI in the target vessel or CABG.
- BMI ≥ 40 kg/m2
- Insufficient CT quality assessed by the Core lab.
- Comorbidity with life expectancy ≤ 2 years.
- Planned major cardiac or non-cardiac surgery within 24 months after the index procedure Note: Major surgery is any invasive operative procedure in which an extensive resection is performed, e.g., a body cavity is entered, organs are removed, or normal anatomy is altered. Note: Minor surgery is an operation on the superficial structures of the body or a manipulative procedure that does not involve a serious risk. Planned minor surgery is not excluded.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 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,
💰 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.