About this trial

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.

Eligibility criteria

Qualifiers

Non-gated chest CT performed within the prior 2 years within the health system

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

Disqualifiers

Dementia

Heart transplant

Active hospice

Other life-limiting illness as determined by the site investigator (e.g., metastatic cancer)

Trial design

Treatments tested in this trial

  • AI-Detected CAC Notification and Care Facilitation

Treatment groups

120,000 Participants
are divided into 2 treatment groups

Locations

6
University of California, Los Angeles90095, Los AngelesCalifornia, United States
Kaiser Permanente Northern California94588, PleasantonCalifornia, United States
Stanford University94305, StanfordCalifornia, United States
Duke University Medical Center27710, DurhamNorth Carolina, United States

Sponsors and collaborators

Stanford University

Lead sponsor

Amgen

Collaborator

Baylor Scott and White Health

Collaborator

Kaiser Permanente

Collaborator

Vanderbilt University Medical Center

Collaborator

Duke University

Collaborator

University of California, Los Angeles

Collaborator