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NOT YET RECRUITING
NCT07808593

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

Sponsor: University of Cologne

View on ClinicalTrials.gov

Summary

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.

Official title: Opportunistic Screening of Coronary Artery Calcium on Non-Gated Routine Chest CT Using Artificial Intelligence: Retrospective External Validation and Clinical Risk Stratification

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1950

Start Date

2026-11-01

Completion Date

2027-12-01

Last Updated

2026-09-09

Healthy Volunteers

No