AI reads heart scans to spot hidden risk and push stronger cholesterol care

NCT ID NCT07834372

What the study statuses mean

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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.
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 22, 2026 · Last updated Sep 22, 2026

Summary

Researchers are testing whether an AI-powered analysis of heart CT scans can help doctors decide when to start or strengthen cholesterol-lowering medication for people with coronary artery disease. The trial enrolls adults who had a heart attack or stent procedure one to five years earlier and who currently have no symptoms. Participants receive a heart CT scan, and half are randomly assigned to have their doctors see the AI analysis while the other half receive usual care without it. The main question is whether seeing the AI results leads more patients to begin or intensify cholesterol treatment.

What this could mean

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

Active substance
AI-powered analysis of heart CT scans (HeartFlow AI-CPA)
What this could lead to
If it works, this could give doctors a clearer way to spot hidden heart risk and adjust cholesterol treatment earlier for people with coronary artery disease.
What could go wrong
The trial may show that the AI scan results do not change how doctors treat patients, or that any changes do not improve outcomes. It is a diagnostic study, not a test of whether the treatment itself saves lives.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 350 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Apr 2029

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.

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: 1. History of PCI (1 year - 5 years prior to Day 0) and/or history of MI (Type I or II) (1 year - 5 years prior to Day 0) 2. Patients who do not exhibit symptoms suggestive of CAD 3. No other clinical CCTA subsequent to MI/PCI but prior to screening 4. eGFR \>45 mL/min per most recent measurement within 90 days 5. Willingness to comply with all aspects of the protocol including research CCTAs, lab draws, medication adherence assessments, attending all study visits, and the ability to comply with prescribed medications 6. For a female participant of childbearing potential (those who have not been surgically sterilized), a pregnancy test must be performed with negative results known within 7 days prior to randomization 7. Ability to provide informed consent 8. Visible plaque in non-stented region on CCTA as assessed by CCTA core lab 9. Acceptable CCTA quality per Heartflow acceptance criteria Exclusion Criteria: Non-imaging based 1. Symptoms suggestive of CAD (e.g. stable angina or dyspnea on exertion) 2. On PCSK9i and/or inclisiran at baseline 3. Reduced left ventricular ejection fraction (LVEF) \<35%, if known 4. Prior coronary artery bypass graft (CABG) 5. Prior stents in 2+ vessel territories 6. Life expectancy less than 2 years due to non-CV comorbidities 7. Enrolled in an investigational trial that involves a non-approved cardiac drug or device 8. Previously evaluated with and/or in a trial which includes AI-CPA 9. Any condition that might interfere with trial procedures or follow up visits 10. LDL-C \<70 mg/dL at baseline lab draw 11. Active chemotherapy and/or radiation Imaging Based (all to be assessed by CCTA core lab) 12. Left Main (LM) ≥50% stenosis on baseline CCTA 13. Proximal LAD FFRct \<0.75 14. Total occlusions in major vessels and/or total occlusion in stent 15. No visible plaque in non-stented segments on CCTA 16. Incidental findings requiring immediate follow-up or management (e.g., Aortic dissection, findings suggestive of cancer, pulmonary embolism) 17. Findings that require further imaging follow-up within 1 year (e.g., pulmonary nodules ≥6 mm)

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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.

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • REWRITE-CAD Trial Site

    Greensboro, North Carolina, 27401, United States

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