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HEARTWISE-ASCVD: AI-Detected CAC Notification for Cholesterol Treatment

This study, called HEARTWISE-ASCVD, is testing if using artificial intelligence (AI) to find calcium buildup in heart arteries (Coronary Artery Calcification or CAC) on existing chest CT scans can help improve cholesterol treatment. If the AI detects significant calcium, your doctor and you would receive a notification. The study aims to see if this leads to starting or increasing cholesterol-lowering medicines. You might be able to join if you are between 18 and 74 years old, have had a chest CT scan in the last two years, and have either known atherosclerotic cardiovascular disease (ASCVD) or significant calcium buildup with uncontrolled cholesterol. The study's main goal is to see if more people start or intensify their cholesterol-lowering therapy within 6 months.

Study design
This is an interventional study with a planned enrollment of 120,000 participants. Participants will be randomized, meaning they are assigned by chance, to receive either early notification or a delayed notification about their AI-detected CAC.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main outcome of the study, starting or intensifying cholesterol-lowering therapy, will be measured 6 months after you are randomized.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07355894

Health Enhanced Artery Risk Tracking With Widespread Implementation and Screening Effort in ASCVD (HEARTWISE-ASCVD)

Not Yet Recruiting
NAAges 18–74InterventionalHealth services
Stanford University
~120,000 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:AI-Detected CAC Notification and Care Facilitation

At a glance

Recruiting sites
0 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Lipid-lowering therapy initiation or intensification (LLTI)
Measured over 6 months after participant randomization

Conditions

Atherosclerotic Cardiovascular Disease (ASCVD)
Coronary Artery Calcification

Explore related trials

AtherosclerosisCoronary Artery Calcification

Where it's being run

6 sites across 4 states
California3
North Carolina1
Tennessee1
Texas1

Study leadership

  • Fatima Rodriguez, MD, MPH · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
Meets one of the following clinical criteria:
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

Exclusion

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

What this trial measures

  • Lipid-lowering therapy initiation or intensification (LLTI)6 months after participant randomization

    * Number of new statin prescriptions * Number of statin doses/intensity increase * Number of PSCK9 inhibitor initiation (monoclonal antibodies and siRNA) * Number of Ezetimibe initiations * Number of Bempedoic acid initiations