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OpenTrials
Completed

NCT Number: NCT05588895

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

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.

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Key information

Conditions

Coronary Artery Calcification

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of new statin prescriptions

    Time frame: Baseline through Month 6

    6-month new statin prescription rate

Secondary outcomes

  1. Number of participants using statin medication

    Time frame: Month 6

    6-month assessment of statin prescription rates

  2. Change in Low-density lipoprotein (LDL) cholesterol

    Time frame: Baseline and Month 6

  3. 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.

  4. 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).

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

NOTIFY 2: Picture of Incidental Calcium To Understand Risk Estimate

Acronym: PICTURE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 20, 2022
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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