NCT07808593Not yet recruiting
Artificial Intelligence - Based Opportunistic Coronary Artery Calcium Scoring on Routine Chest-CT Scan
Opportunistic Screening of Coronary Artery Calcium on Non-Gated Routine Chest CT Using Artificial Intelligence: Retrospective External Validation and Clinical Risk Stratification
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 1950 (estimated)
- First submitted
- 1 Sept 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 1 Nov 2027
- Lead sponsor
- University of Cologne
- NCT number
- NCT07808593
What you commit to
- Study type: Observational
- Planned participants: 1950
- From 1 Nov 2026 to the primary completion date, 1 Nov 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Documented objection to the scientific use of the data pursuant to Art. 21 GDPR.
- Cases lacking the minimum data required for analysis (insufficient image quality or missing reference/outcome data).
Who the study is looking for
- Validation cohort: patients with a paired non-gated chest CT and an ECG-gated cardiac CT acquired within ≤ 12 months.
- Dialysis cohort: hemodialysis patients with serial non-gated CTs, plus matched kidney-healthy controls.
- Emergency department cohort: patients \> 50 years with non-gated chest CTs from the Emergency Department without a primary cardiac focus.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.