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

Stanford University

Status: Begins enrollment this month

Conditions: Atherosclerotic Cardiovascular Disease (ASCVD); Coronary Artery Calcification

Treatments: Other: AI-Detected CAC Notification and Care Facilitation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07355894

84062

Details and patient eligibility

About

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.

Enrollment: 120,000 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120,000 participants in 2 patient groups

Early Notification

Experimental group

Description:

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.

Treatment:

Other: AI-Detected CAC Notification and Care Facilitation

Delayed Notification

No Intervention group

Description:

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.