AI reads heart scans to guide treatment in 20,000 patients

NCT ID NCT06376851

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This registry is collecting data from 20,000 people with coronary artery disease to see if an AI tool that analyzes CT scans of the heart can help doctors make better treatment decisions. The AI measures the amount and type of plaque in the arteries. Researchers will compare how medical management changes after doctors get the AI results versus standard CT scans alone. This is an observational study, so no new treatment is being tested.

What this could mean

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

Active substance
AI-enabled quantitative coronary plaque analysis (AI-QCPA)
What this could lead to
If successful, this could show that AI analysis of CT scans helps doctors choose better treatments for heart disease patients.
What could go wrong
This is an observational registry, not a treatment trial, so it won't prove that AI analysis directly improves health outcomes. Results may not apply to all 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 20,000 people

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

Started

Mar 2024

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Deidentified data will be collected for all patients who have had a CCTA with plaque detected or a stress test and are included by the site in the registry.

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 (all must be present) : 1. Groups 1, 2,4,5 and 6: CCTA and plaque detected 2. Group 3: Any patient with a stress test (stress echocardiogram or nuclear imaging including SPECT or PET) and no CCTA within the 90 days prior to site activation 3. Groups 1,2,3 and 4: Clinically stable, symptomatic 4. Group 6: Clinically stable without symptoms suggestive of CAD at the time of the CCTA Exclusion Criteria (all must be absent) : 1. ED presentation (at the time of the CCTA or stress test) 2. Groups 1,2,3,4, and 6: Previous history of CAD (prior to the CCTA or stress test with history of revascularization) 3. Group 5: Prior history of PCI in multiple vessel territories, PCI in the Left Main, CABG, and/or any other conditions or limitations which would prevent successful CCTA processing by HeartFlow 4. Acute chest pain (in patients who have not been ruled out for ACS) 5. Previously evaluated with and/or in a study which includes AI-QCPA

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Moses Cone Memorial Hospital

    Greensboro, North Carolina, 27401, United States

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