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.

NCT Number	NCT07355894
Lead Sponsor	Stanford University Collaborators: Amgen, Baylor Scott and White Health, Kaiser Permanente, Vanderbilt University Medical Center, Duke University, University of California, Los Angeles
Conditions	Atherosclerotic Cardiovascular Disease (ASCVD), Coronary Artery Calcification
Enrollment	120,000 participants
Start Date	2026-05
Primary Completion	2027-09 (estimated)
Study Completion	2028-03 (estimated)
Updated on ClinicalTrials.gov	2026-04-22