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

Official title

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

Overview

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.

Interventions

• 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 personal

Primary outcome measures

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

Secondary outcome measures (5)

• Aspirin prescription [Time frame: 6 months after participant randomization]
• Lipid panel (total cholesterol, HDL-C, LDL-C, triglycerides) ordering [Time frame: 6 months after participant randomization]
• Lipoprotein(a) test ordering [Time frame: 6 months after participant randomization]
• Changes of total cholesterol, HDL-C, LDL-C, triglycerides, Lipoprotein(a) levels [Time frame: 6 months after participant randomization]
• Healthcare resource use [Time frame: Baseline through Month 6]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 6 centers

• University of California, Los Angeles — Los Angeles
• Kaiser Permanente Northern California — Pleasanton
• Stanford University — Stanford
• Duke University Medical Center — Durham
• Vanderbilt University Medical Center — Nashville
• Baylor Scott & White — Dallas

Identifiers

NCT: NCT07355894 · 84062

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗