- 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) — Recruiting • Non-phase study • Cardiology / Cardiovascular • NCT07286578.
- What is being tested: The trial compares two coronary imaging strategies—a calcium modification approach guided by coronary CT angiography (CCTA) versus standard imaging protocols—to determine whether CCTA-informed strategies improve procedural efficiency and effectiveness in managing coronary calcium during intervention.
- Patient eligibility overview: The trial includes patients requiring coronary intervention who have coronary calcium present, representing a clinically relevant population where calcium burden affects procedural complexity and outcomes.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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.
- : * The subject must be at least 18 years of age and younger than 85 years old * Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia (ischemia in the absence of chest pain or other anginal equivalents), unstable angina, or acute myocardial infarction) suitable for PCI. Patients with a clinical indication for revascularization presenting with stable coronary artery disease or stabilized acute coronary syndrome defined as follows unstable angina (Braunwald class IB, IC, IIB, IIC, IIIB, IIIC), patients with NSTEMI without high-risk features such as recurrence of chest pain, ST-segment depression>1mm in ≥6 leads plus STsegment elevation in aVR, life-threatening arrhythmias, mechanical complications of MI, resuscitated cardiac arrest, GRACE risk score>140. * All target vessels must have reference vessel diameter (visually assessed by CCTA) ≥ 2.5 mm * Subject must provide written informed consent before any study-related procedure
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.