Cure My Disease

Don't miss your cure!

 Log in / Sign up

Opportunistic screening of coronary artery calcium on Non-Gated routine chest CT using artificial intelligence: retrospective external validation and clinical risk stratification

NCT ID NCT07808593

NEW Sponsor: University of Cologne Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,950 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Retrospective patients at University Hospital Cologne with routine clinical CT imaging (01 January 2015 - 31 December 2025), across three analytic cohorts (validation, dialysis, emergency department); approximately 1,950 cases.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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).

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Cardiovascular risk are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

coronary artery disorder coronary atherosclerosis end stage renal failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular risk Coronary artery calcification Coronary artery disease Emergency care End-stage renal disease requiring haemodialysis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.