Actively Recruiting
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)
Led by Fundación EPIC · Updated on 2026-02-10
700
Participants Needed
13
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to younger than 85 years
- Evidence of myocardial ischemia suitable for PCI, including stable angina, silent ischemia, unstable angina, or acute myocardial infarction with stabilized acute coronary syndrome
- Clinical indication for revascularization in stable coronary artery disease or stabilized acute coronary syndrome as defined
- All target vessels must have reference vessel diameter of at least 2.5 mm by CCTA
- Written informed consent provided before any study procedure
You will not qualify if you...
- ST-elevation myocardial infarction (STEMI) as clinical presentation
- Uncontrolled or recurrent ventricular tachycardia
- Hemodynamic instability
- Receiving hemodialysis or peritoneal dialysis
- Left main coronary artery stenosis greater than 50%
- Atrial fibrillation, flutter, or arrhythmias during CT acquisition
- Previous PCI in the target vessel or coronary artery bypass grafting
- Body mass index (BMI) 40 kg/m2 or higher
- Insufficient CT image quality
- Life expectancy of 2 years or less due to comorbid conditions
- Planned major cardiac or non-cardiac surgery within 24 months after the procedure
- Solid organ transplant recipient or active on transplant waiting list expecting transplant within 24 months
- Receiving immunosuppressant therapy or having severe autoimmune diseases requiring such therapy
- Prior or scheduled radiotherapy to coronary arteries or chest/mediastinum
- Platelet count below 100,000 or above 700,000 cells/mm3
- Documented or suspected liver cirrhosis or Child-Pugh Class B or higher
- History of bleeding disorders or significant recent bleeding
- Recent cerebrovascular accident, transient ischemic attack, intracranial bleed, or known intracranial pathology
- Participation in another investigational drug or device study
- Pregnant, nursing, or planning pregnancy within 2 years after procedure
- Other medical, social, or psychological conditions limiting participation or follow-up
- Unable to provide written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Bringham and Women's Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
2
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
Not Yet Recruiting
3
HACKENSACK MERIDIAN HEALTH, Inc
Jersey City, New Jersey, United States, 08837
Not Yet Recruiting
4
Columbia University Irving Medical Center/NewYork-Presbyterian Hospital
New York, New York, United States, 10032
Not Yet Recruiting
5
Weill Medical College of Cornell University
New York, New York, United States, 14853
Not Yet Recruiting
6
Hospital Universitari Vall Hebron
Barcelona, Spain, 08035
Actively Recruiting
7
Hospital Universitario de Leon
León, Spain
Actively Recruiting
8
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
9
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
Not Yet Recruiting
10
St Bartholomew's Hospital (Barts Health NHS Trust)
London, United Kingdom
Not Yet Recruiting
11
St George's University Hospitals NHS Foundations Trust
London, United Kingdom
Not Yet Recruiting
12
Newcastle Hospitals NHS Foundations Trust
Newcastle, United Kingdom
Not Yet Recruiting
13
John Radcliffe Hospital, Oxford
Oxford, United Kingdom
Not Yet Recruiting
Research Team
C
CAROLINA FOCELLA
CONTACT
C
CARLOS COLLET, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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