Trials / Completed
CompletedNCT05588895
Picture of Incidental Calcium To Understand Risk Estimate (PICTURE) Trial
NOTIFY 2: Picture of Incidental Calcium To Understand Risk Estimate
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 202 (actual)
- Sponsor
- Stanford University · Academic / Other
- Sex
- All
- Age
- 18 Years – 84 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective randomized controlled trial assessing the impact of notifying patients and their clinicians of an incidental finding of coronary artery calcification (CAC) indicating increased cardiovascular risk. Patients will be identified through completed radiology orders for non-gated, non-contrast chest CT in the appropriate clinical context and then will have an EHR screen for inclusion criteria. The presence of CAC will be confirmed by a radiologist. Eligible patients will be randomized to CAC notification or usual care using a 1:1 stratified block randomization method based on baseline ASCVD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Notification | For patients randomized to notification, the affiliated non-EP cardiologist, if present, or if patient does not have one, the PCP will be notified and will receive an electronic health record (EHR) message notifying them of the presence of CAC (with images) and the ACC/AHA guideline recommendation to consider starting statin therapy. Simultaneously, the patient will be notified via a MyHealth message describing the presence of CAC with personalized scan images, its significance, and the recommendation that statin therapy should be considered. For the notification arm, we will check for either statin prescription or a documented discussion in the EHR at 2 months. For those not prescribed a statin and without a documented discussion in Epic at 2 months follow-up, we will send a repeat notification to their home address and to their affiliated clinician. |
Timeline
- Start date
- 2024-01-08
- Primary completion
- 2026-01-15
- Completion
- 2026-01-15
- First posted
- 2022-10-20
- Last updated
- 2026-02-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05588895. Inclusion in this directory is not an endorsement.