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AI could turn routine chest scans into heart risk warnings

NCT ID NCT07808593

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

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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.
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Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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The trial has finished. Results may not be published yet.
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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)

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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

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Status unknown
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First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Researchers are testing whether an open-source artificial intelligence model can measure coronary artery calcium on routine chest CT scans that were not originally taken for heart imaging. The study uses existing scans from about 1,950 people at a German hospital, including patients with paired cardiac CTs, dialysis patients, and older emergency department patients. The goal is to see how well the AI score matches standard calcium measurements and whether it can predict heart events and death. No patients receive any intervention.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an open-source artificial intelligence algorithm called Swin-UNETR that measures coronary artery calcium on routine chest CT scans
What this could lead to
If it works, routine chest CT scans could flag hidden heart risk without extra tests, helping doctors spot people who need closer cardiac care.
What could go wrong
The study is retrospective and tests the algorithm on scans from one German center, so results may not hold on other scanners or in different populations. The AI may miss or misread calcium, and the study cannot prove that acting on its scores improves outcomes.

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).

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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

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  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

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