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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Calcification; Atherosclerotic Cardiovascular Disease (ASCVD)
• Intervention / Treatment: Other: AI-Detected CAC Notification and Care Facilitation

• Study Type: Interventional
• Enrollment (Estimated): 120000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles
    • Pleasanton, California, United States, 94588
      • Kaiser Permanente Northern California
    • Stanford, California, United States, 94305
      • Stanford University
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 95226
      • Baylor Scott & White

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: AI-Detected CAC Notification and Care Facilitation; 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid-lowering therapy initiation or intensification (LLTI)	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	6 months after participant randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aspirin prescription	Number of new Aspirin or other antiplatelet prescription	6 months after participant randomization
Lipid panel (total cholesterol, HDL-C, LDL-C, triglycerides) ordering	Number of Lipid panel ordering	6 months after participant randomization
Lipoprotein(a) test ordering	Number of Lipoprotein(a) test ordering	6 months after participant randomization
Changes of total cholesterol, HDL-C, LDL-C, triglycerides, Lipoprotein(a) levels	This outcome measure the changes of the test levels	6 months after participant randomization
Healthcare resource use	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)	Baseline through Month 6

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: University of California, Los Angeles; Duke University; Vanderbilt University Medical Center; Kaiser Permanente; Amgen; Baylor Scott and White Health
• Investigators: Principal Investigator: Fatima Rodriguez, MD, MPH, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: 84062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No