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AI heart scan trial aims to sharpen diagnosis of clogged arteries

NCT ID NCT06713239

Diagnosis Sponsor: Cleerly, Inc. 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares a new AI-based method of analyzing CT scans of the heart to standard care for people with symptoms that might be coronary artery disease. The goal is to see if the AI approach helps doctors diagnose the condition more accurately, control risk factors like cholesterol, and reduce unnecessary invasive procedures. About 1000 participants will be randomly assigned to either the AI-guided or usual care group.

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 1,000 people

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

Started

Dec 2024

Expected to finish

Dec 2026

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: * \> 18 years * Symptomatic patients with suspicion of CAD, including those referred for elective, non-urgent diagnostic testing (e.g. stress test) Exclusion Criteria: * LDL \< 100 mg/dL * Currently or previously treated beyond primary prevention guidelines * Suspected acute coronary syndrome or otherwise unstable clinical status * Planned cardiovascular procedure (e.g. coronary angiography, cardiac surgery, non-coronary vascular procedure) * Noninvasive or invasive CV testing for CAD within 1 year (e.g. invasive coronary angiography (ICA), coronary CT angiography (CCTA) including calcium scoring) * Known history of obstructive CAD (prior myocardial infarction, CABG or PCI, stenosis ≥50%) * Known EF ≤40% or other moderate to severe valvular or congenital cardiac disease * Contraindications to CCTA

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

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

Coronary artery disease

Contacts and locations

Locations

  • Advanced Heart and Vascular Institute of Hunterdon

    Flemington, New Jersey, 08822, United States

  • Capital Cardiology Associates

    Albany, New York, 12211, United States

  • Cardiology Associates of Mobile

    Mobile, Alabama, 36608, United States

  • Cardiovascular Institute of San Diego

    San Diego, California, 91911, United States

  • Chippenham and Johnston Willis Hospitals

    Richmond, Virginia, 23225, United States

  • Endeavor Health Clinical Operations

    Evanston, Illinois, 60201, United States

  • Flourish Research

    Winter Park, Florida, 32789, United States

  • Flourish- Bowie

    Bowie, Maryland, 20715, United States

  • Intermountain Health Saint Joseph Hospital

    Broomfield, Colorado, 80021, United States

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California, 90502, United States

  • Medical City Fort Worth Hospital

    Fort Worth, Texas, 76104, United States

  • MercyOne Des Moines Medical Center

    West Des Moines, Iowa, 50266, United States

  • Oklahoma Cardiovascular Research Group

    Oklahoma City, Oklahoma, 73120, United States

  • Saint Elizabeth Medical Center

    Edgewood, Kentucky, 41017, United States

  • St. Louis Heart and Vascular

    Bridgeton, Missouri, 63044, United States

  • Tampa Cardiovascular Interventions and Research

    Tampa, Florida, 33614, United States

  • The University of Tennessee Medical Center

    Knoxville, Tennessee, 37920, United States

  • Tulane University

    New Orleans, Louisiana, 70112, United States

  • University of Cincinnatti

    Cincinnati, Ohio, 45221, United States

  • Valiance Clinical Research- Huntington Park

    Huntington Park, California, 90255, United States

  • Valiance Clinical Research- Tarzana

    Tarzana, California, 91356, United States

More trials for these conditions

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