An interventional study of AI-Detected CAC Notification and Care Facilitation in Atherosclerotic Cardiovascular Disease (ASCVD) and Coronary Artery Calcification, sponsored by Stanford University. Not yet recruiting at 6 sites in United States. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Stanford University · Not applicable, Interventional, and Health services research
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.
1,567 studies on the registry are indexed under Atherosclerosis; 265 are open to participants now.
This study's planned enrollment of 120,000 is above the median of 106 across 882 interventional studies indexed under Atherosclerosis.
Browse Atherosclerosis studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Meets one of the following clinical criteria:
Note: Site-level variations and additional refinements may occur based on local stakeholder input and patient population identification.
Exclusion Criteria:
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.
Other: AI-Detected CAC Notification and Care Facilitation
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.
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 personalized image of AI-CAC, and a recommended risk discussion with their clinician. These clinicians will also be notified of the findings. For participants randomized to early notification who do not undergo LLT initiation, intensification, or LDL testing within 2 months, the clinician and participant will receive a second message at that time. The participants in the delayed notification arm will receive a similar notification 6 months later.
Lipid-lowering therapy initiation or intensification (LLTI)
* Number of new statin prescriptions * Number of statin doses/intensity increase * Number of PSCK9 inhibitor initiation (monoclonal antibodies and siRNA) * Number of Ezetimibe initiations * Number of Bempedoic acid initiations
Time frame: 6 months after participant randomization
Aspirin prescription
Number of new Aspirin or other antiplatelet prescription
Time frame: 6 months after participant randomization
Lipid panel (total cholesterol, HDL-C, LDL-C, triglycerides) ordering
Number of Lipid panel ordering
Time frame: 6 months after participant randomization
Lipoprotein(a) test ordering
Number of Lipoprotein(a) test ordering
Time frame: 6 months after participant randomization
Changes of total cholesterol, HDL-C, LDL-C, triglycerides, Lipoprotein(a) levels
This outcome measure the changes of the test levels
Time frame: 6 months after participant randomization
Healthcare resource use
* Number of primary care clinical encounters * Number of cardiology encounters * Number of coronary artery disease-related imaging tests (e.g. noninvasive stress tests, coronary computed tomography angiography (CCTAs), and angiograms)
Time frame: Baseline through Month 6
Plan to share: No
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