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Artificial Intelligence - Based Opportunistic Coronary Artery Calcium Scoring on Routine Chest-CT Scan

StatusNot Yet Recruiting
PhaseNot specified
Started2026-11-01
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This retrospective, non-interventional study externally validates a pre-trained open-weight deep-learning algorithm (Swin-UNETR) for the opportunistic quantification of coronary artery calcium (CAC) on non-gated routine chest CT scans acquired at a German academic center, and evaluates the prognostic value of this automated imaging biomarker for cardiovascular risk stratification. Coronary calcium is an established predictor of cardiovascular risk, but is not routinely quantified on the tens of thousands of non-cardiac chest CTs performed each year. Because existing high-performing AI models were trained almost exclusively on U.S. cohorts, external validation on a European scanner fleet is required to exclude scanner bias (domain shift). The study comprises three linked analytic cohorts: (1) a validation cohort comparing the AI-CAC score against the ECG-gated cardiac CT Agatston reference; (2) a dialysis cohort assessing calcification progression and mortality; and (3) an emergency department cohort assessing short-term cardiovascular events. This is an investigator-initiated trial with no intervention on patients.
Trial Details
NCT Number NCT07808593
Lead Sponsor University of Cologne
Collaborators: Institute for Diagnostic and Interventional Radiology, University Hospital Cologne, Medical Data Integration Center (MeDIC), University Hospital Cologne
Conditions Coronary Artery Calcification, Cardiovascular Risk, Coronary Artery Disease, End-Stage Renal Disease Requiring Haemodialysis, Emergency Care
Enrollment 1,950 participants
Start Date 2026-11-01
Primary Completion 2027-11-01 (estimated)
Study Completion 2027-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-09