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

February 19, 2026 updated by: Fatima Rodriguez, Stanford University

NOTIFY 2: Picture of Incidental Calcium To Understand Risk Estimate

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Notification
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

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.
No Intervention: Usual Care

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of new statin prescriptions
Time Frame: Baseline through Month 6
6-month new statin prescription rate
Baseline through Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Low-density lipoprotein (LDL) cholesterol
Time Frame: Baseline and Month 6
Baseline and Month 6
Change in 10-Year Atherosclerotic Cardiovascular Disease (ASCVD) Pooled Cohort Equation
Time Frame: Baseline and Month 6
This outcome measures the 10 year risk of ASCVD events.
Baseline and Month 6
Number of events requiring primary care intervention, cardiology referrals, or cardiac testing
Time Frame: Baseline through Month 6
This outcome assesses healthcare resource use (primary care clinical encounters, cardiology referrals, cardiac testing).
Baseline through Month 6
Number of participants using statin medication
Time Frame: Month 6
6-month assessment of statin prescription rates
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Fatima Rodriguez, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2024

Primary Completion (Actual)

January 15, 2026

Study Completion (Actual)

January 15, 2026

Study Registration Dates

First Submitted

October 17, 2022

First Submitted That Met QC Criteria

October 17, 2022

First Posted (Actual)

October 20, 2022

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 67227

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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