Rustworthy, Integrated Artificial Intelligence Tools for Predicting High-risk CORonary PlaqueS
Sponsor: Centro Cardiologico Monzino
Trial Details
| Condition | Coronary Artery Disease, Coronary Computed Tomography Angiography |
| Status | Recruiting |
| Participants | 4,000 |
| Est. Completion | 30 Nov 2026 |
| Last Updated | 29 May 2026 |
Primary Outcome
Creation of an automated integrative artificial intelligence (AI) approach for the stratification of CAD patients and assessment of vulnerable coronary plaques at risk of acute complications; Quantitative assessment of the atherosclerotic burden and high risk plaque features
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: * patients (age ≥ 18 years) with known or suspected CAD referred for clinically indicated diagnostic evaluation; * CCTA performed with state-of-the-art scanner technology, i.e., scanners with more than 64 slices. Exclusion Criteria: * performance of any non-invasive diagnostic test within 90 days before enrolment; * low-to-intermediate pre-test likelihood of CAD according to the updated Diamond-Forrester risk model score; * acute coronary syndrome; * evidence of clinical instability; * contraindication to contrast agent administration and/or impaired renal function; * inability to sustain a breath hold; * pregnancy; * cardiac arrhythmias;- presence of a pacemaker or implantable cardioverter defibrillator; * contraindications to the administration of sublingual nitrates, β-blockers or adenosine; * structural cardiomyopathy
Trial Sites
Countries
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