Picture of Incidental Calcium To Understand Risk Estimate (PICTURE) Trial

NCT05588895 | Completed

• 1 other identifier: 67227
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief 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

Coronary Artery Calcification

Outcome Measures

Primary Outcomes (1)

• Number of new statin prescriptions

  6-month new statin prescription rate

  Baseline through Month 6

Secondary Outcomes (4)

• Number of participants using statin medication

  Month 6

• Change in Low-density lipoprotein (LDL) cholesterol

  Baseline and Month 6

• Change in 10-Year Atherosclerotic Cardiovascular Disease (ASCVD) Pooled Cohort Equation

  Baseline and Month 6

• Number of events requiring primary care intervention, cardiology referrals, or cardiac testing

  Baseline through Month 6

Study Arms (2)

Notification

EXPERIMENTAL

The notification arm will have its CT scans interpreted and reported according to standard clinical practice. A standardized notification message using the EHR will be sent to the patient's Stanford affiliated non-EP cardiologist, if present, or the primary care clinician if there is no non-EP cardiologist. After a two week delay from notifying the patient's non-EP cardiologist or PCP, a standardized notification message will be sent to the patient. The message will include an image of the CAC from the chest CT. All communications will be signed by the Principal Investigator. Any treatment decisions will be made by the patient and their clinician.

Other: Notification

Usual Care

NO INTERVENTION

The usual care arm will have its 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. The usual care arm will not receive any notification beyond this standard of care. We intend to notify patients in the usual care arm when study ends, if we determine that notification is effective at increasing statin rates.

Interventions

Notification OTHER

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.

Notification

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and above and \<85
• Non-gated chest CT with CAC
• An encounter after July 1, 2021 with a Stanford-affiliated clinician from one of the following clinics:
• Stanford Internal Medicine (includes University affiliated clinics)
• Stanford Family Medicine (includes University affiliated clinics)
• Non-EP cardiologist

You may not qualify if:

• Advanced or poor-prognostic cancer
• No active primary care or cardiology care at Stanford Health Care
• Primary language other than English, Spanish, Vietnamese, Cantonese, or Mandarin
• Baseline statin or non-statin lipid lowering therapy
• Allergy to statin medication or identification of statin-associated muscle symptom

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine (Cardiovascular Medicine)

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 20, 2022
• Study Start: January 8, 2024
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)