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NCT07355894 · ClinicalTrials.gov registry record · NA
Health Enhanced Artery Risk Tracking With Widespread Implementation and Screening Effort in ASCVD (HEARTWISE-ASCVD)
A NA study, sponsored by Stanford University.
- Not yet
- Registry status
- NA
- Development phase
- 120,000
- Enrollment target
NCT07355894: Clinical Trial NA study, sponsored by Stanford University.
NCT07355894 is a NA study that has not yet begun recruiting, run by Stanford University. The registered enrollment target is 120,000 participants, above the 1,402-participant average among 58,714 other NA trials with a reported enrollment target (8459% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07355894, a NA study, has not yet begun recruiting, sponsored by Stanford University.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 120,000 participants
- Enrollment target
Study Summary
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.
Primary Outcome
* 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
Interventions
- OTHER AI-Detected CAC Notification and Care Facilitation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120,000 participants |
| Start Date | 2026-05 |
| Est. Completion | 2028-03 |
| Phase | NA |
What is known before NCT07355894 opens enrollment
NCT07355894 is an interventional study that assigns participants to a tested intervention. Its 120,000 participants enrollment target places it among the larger protocols in the corpus, above the 1,402-participant average among 58,714 other NA trials with a reported enrollment target (8459% higher).
The record links to 0 conditions, and to 1 intervention - of which AI-Detected CAC Notification and Care Facilitation is the first listed.
NCT07355894 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07355894 about?
NCT07355894 is a clinical study titled "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) ...
What is the current status of trial NCT07355894?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 120,000 participants. The study started on 2026-05. Estimated completion is 2028-03.
What interventions are being tested in trial NCT07355894?
The interventions under investigation include: AI-Detected CAC Notification and Care Facilitation (OTHER).
Who is sponsoring clinical trial NCT07355894?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07355894's enrollment target sits among peer trials
120,000 2nd of 2000 the highest of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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