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AI spots hidden heart risk in old scans, prompts better treatment

NCT ID NCT07355894

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study will test if using artificial intelligence to find calcium buildup in heart arteries from chest CT scans people already had can improve cholesterol treatment. Researchers will notify patients and their doctors about the finding, aiming to start or strengthen cholesterol-lowering medications. The study includes 120,000 adults with known heart disease or significant calcium buildup whose cholesterol is not well controlled. It is not a cure but a way to better manage heart disease and reduce future risk.

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 120,000 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

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.

Ages

18 to 74 years

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: * Non-gated chest CT performed within the prior 2 years within the health system * Active health system engagement with an affiliated clinician eligible for notification, defined as ≥1 clinical visit within the prior 2 years AND at least one of the following: 1. Active enrollment in the site's integrated healthcare plan (e.g., Kaiser Permanente Northern California), OR 2. LDL-C measured within the health system within the prior 2 years, OR 3. Outpatient cardiovascular medication prescription within the prior year * Meets one of the following clinical criteria: 1. Clinical ASCVD diagnosis (coronary artery disease, peripheral arterial disease, or ischemic cerebrovascular disease) AND AI-detected CAC \>0 on non-gated chest CT, OR 2. No ASCVD diagnosis AND AI-detected CAC ≥100 * Suboptimal LDL-C control, defined as either: Last LDL-C ≥70 mg/dL in the last 2 years, OR No LDL-C measurement in the last 2 years Note: Site-level variations and additional refinements may occur based on local stakeholder input and patient population identification. Exclusion Criteria: * Dementia * Heart transplant * Active hospice * Other life-limiting illness as determined by the site investigator (e.g., metastatic cancer) * Additional participant-level exclusions as determined by clinical stakeholders at each site

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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

    6 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Baylor Scott & White

    Dallas, Texas, 95226, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Kaiser Permanente Northern California

    Pleasanton, California, 94588, United States

  • Stanford University

    Stanford, California, 94305, United States

  • University of California, Los Angeles

    Los Angeles, California, 90095, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

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