AI-Detected CAC Notification for Cardiovascular Disease
(HEARTWISE Trial)
What You Need to Know Before You Apply
What is the purpose of 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.
Who Is on the Research Team?
Fatima Rodriguez, MD, MPH
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
This trial is for adults with known heart artery disease or significant calcium in their arteries, and who have high cholesterol levels. They must have had a chest CT scan within the last two years and be part of an integrated healthcare plan or have recent cholesterol measurements or cardiovascular medication prescriptions.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive AI-based CAC screening and notification intervention to improve cholesterol treatment
Follow-up
Participants are monitored for changes in lipid levels and healthcare resource use
What Are the Treatments Tested in This Trial?
Interventions
- AI-Detected CAC Notification and Care Facilitation
Trial Overview
The study tests if AI-based screening to detect calcium buildup in heart arteries on existing CT scans can help manage cholesterol better by notifying patients and doctors. It will check if this leads to more use of cholesterol-lowering treatments, better control of bad cholesterol (LDL), and changes in follow-up care.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
Kaiser Permanente
Collaborator
University of California, Los Angeles
Collaborator
Amgen
Industry Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London
Baylor Scott and White Health
Collaborator
Vanderbilt University Medical Center
Collaborator
Duke University
Collaborator
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