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NCT Number: NCT07355894

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

This multi-site study will test whether an opportunistic AI-based CAC screening and notification intervention can improve cholesterol treatment and lower cholesterol levels in adults. The study uses artificial intelligence to detect calcium buildup in heart arteries (coronary artery calcium or CAC) on chest CT scans that patients have already had for other reasons. The study will focus on adults who either have known atherosclerotic cardiovascular disease (ASCVD) or have significant calcium buildup (a CAC score of 100 or higher), and whose cholesterol is not well controlled.

It will also evaluate how well this approach can be implemented at scale across multiple health systems. The main questions it aims to answer are:

Does notifying patients and their clinicians about incidental CAC increase lipid-lowering therapy(LLT) initiation or intensification?

Does the intervention improve Low-Density Lipoprotein(LDL)-cholesterol control and related lipid testing?

How does the intervention affect downstream care (e.g., clinic visits, cardiology referrals, and cardiac testing)?

Researchers will use an FDA-cleared AI algorithm to quantify CAC on previously performed non-gated chest CT scans and identify eligible participants through the electronic health record. Participants will be randomized to receive CAC notification either right away or after a 6-month delay.

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Key information

Conditions

Atherosclerotic Cardiovascular Disease (ASCVD) Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Coronary Artery Calcification Vascular Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Active enrollment in the site's integrated healthcare plan (e.g., Kaiser Permanente Northern California), OR
  • LDL-C measured within the health system within the prior 2 years, OR
  • Outpatient cardiovascular medication prescription within the prior year
  • Meets one of the following clinical criteria:
  • Clinical ASCVD diagnosis (coronary artery disease, peripheral arterial disease, or ischemic cerebrovascular disease) AND AI-detected CAC >0 on non-gated chest CT, OR
  • 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

Treatment and study plan

AI-Detected CAC Notification and Care Facilitation

Other

After randomization to the early notification arm, the study team will send a standardized notification message to the participant's affiliated clinician. The study team will send a message to the participant after a brief delay. Each site will determine the timing between the initial message to the clinician and the participant based on stakeholder feedback.

The notification is about the AI-CAC identified on the participant's previous chest CT. It will provide an overview of AI-CAC, a personalized image of AI-CAC, and a recommended risk discussion with their clinician. These clinicians will also be notified of the findings.

For participants randomized to early notification who do not undergo LLT initiation, intensification, or LDL testing within 2 months, the clinician and participant will receive a second message at that time.

The participants in the delayed notification arm will receive a similar notification 6 months later.

Primary outcomes

  1. Lipid-lowering therapy initiation or intensification (LLTI)

    Time frame: 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

Secondary outcomes

  1. Aspirin prescription

    Time frame: 6 months after participant randomization

    Number of new Aspirin or other antiplatelet prescription

  2. Lipid panel (total cholesterol, HDL-C, LDL-C, triglycerides) ordering

    Time frame: 6 months after participant randomization

    Number of Lipid panel ordering

  3. Lipoprotein(a) test ordering

    Time frame: 6 months after participant randomization

    Number of Lipoprotein(a) test ordering

  4. Changes of total cholesterol, HDL-C, LDL-C, triglycerides, Lipoprotein(a) levels

    Time frame: 6 months after participant randomization

    This outcome measure the changes of the test levels

  5. Healthcare resource use

    Time frame: Baseline through Month 6

    • Number of primary care clinical encounters
    • Number of cardiology encounters
    • Number of coronary artery disease-related imaging tests (e.g. noninvasive stress tests, coronary computed tomography angiography (CCTAs), and angiograms)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Amgen
  • Baylor Scott and White Health
  • Duke University
  • Kaiser Permanente
  • University of California, Los Angeles
  • Vanderbilt University Medical Center

Registry information

Official study title

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

Acronym: HEARTWISE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 21, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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