AI spots hidden heart risk in old scans, prompts better treatment
NCT ID NCT07355894
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 120,000 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 74 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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Get notified about this study
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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.
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The places running it
6 sites. The list below names each one and where it is.
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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.
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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
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Baylor Scott & White
Dallas, Texas, 95226, United States
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Duke University Medical Center
Durham, North Carolina, 27710, United States
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Kaiser Permanente Northern California
Pleasanton, California, 94588, United States
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Stanford University
Stanford, California, 94305, United States
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University of California, Los Angeles
Los Angeles, California, 90095, United States
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Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- AI could turn routine chest scans into heart risk warnings
- Do complex heart procedures expose patients to more harmful radiation and contrast?
- Can sound waves crush artery calcium and save hearts?
- Can a drop of blood predict disease years before it strikes?
- Which heart procedure spares tiny vessels? study compares two Calcium-Busting techniques
- New hope for heart patients: pelacarsen available through special program