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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Stanford University
Study ID
NCT07355894
Status
Not Yet Recruiting

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Conditions

  • Atherosclerotic Cardiovascular Disease (ASCVD)
  • Coronary Artery Calcification

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Jan 2026
Primary completion
Sep 30, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
120,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Early Notification
    For participants randomized to notification, the affiliated clinician will receive a message notifying them of the presence of CAC. The notification will include a description of the significance of CAC, provide guideline recommendations, and include a personalized CAC image (as possible). The message will recommend having a risk discussion with the participant. Based on site-level stakeholder feedback, this alert can be retriggered at 2 months for participants who do not have LLT initiation or intensification or LDL-C testing. Participants will also receive a notification. Based on stakeholder input, this notification can be delivered centrally or from individual clinicians. The notification will include a description of the significance of CAC, a personalized image (as possible), and recommend a risk discussion with their clinician.
  • No Intervention: Delayed Notification
    Participants will have their CT scans interpreted and reported according to standard clinical practice. This may mention the presence of CAC in the official radiology imaging report, per usual practice. Participants will not receive any notification beyond this standard of care during the 6-month study period. The study team will send a similar notification as the early notification arm to the participants after completion of the study's primary endpoint assessment.

Primary Outcome Measure

Lipid-lowering therapy initiation or intensification (LLTI) [ Time Frame: 6 months after participant randomization ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095-
Kaiser Permanente Northern CaliforniaPleasantonCalifornia94588-
Stanford UniversityStanfordCalifornia94305-
Duke University Medical CenterDurhamNorth Carolina27710-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Baylor Scott & WhiteDallasTexas95226-

Find similar trials in Los Angeles, CA

By research site
University of California, Los Angeles· Los Angeles, CAKaiser Permanente Northern California· Pleasanton, CAStanford University· Stanford, CADuke University Medical Center· Durham, NCVanderbilt University Medical Center· Nashville, TNBaylor Scott & White· Dallas, TX

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