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

Not Applicable

Active, not recruiting

• Conditions: Coronary Artery Calcification
• Interventions: Other: Notification

• Registration Number: NCT05588895
• Lead Sponsor: Stanford University

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 board-certified physician. Eligible patients will be randomized to CAC notification or usual care using a 1:1 stratified block randomization method based on baseline statin use.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-17
• Study First Submitted QC: 2022-10-17
• Study First Posted: 2022-10-20
• Study Start: 2024-01-08
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Notification	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.

Primary Outcome Measures

Name	Time	Method
Number of new statin prescriptions or increased dose prescriptions	Baseline through Month 6	6-month new statin prescription rate or increase in dosage if baseline statin use

Secondary Outcome Measures

Name	Time	Method
Number of events requiring primary care intervention, cardiology referrals, or cardiac testing	Baseline through Month 6	This outcome assesses healthcare resource use (primary care clinical encounters, cardiology referrals, cardiac testing).
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	This outcome measures the 10 year risk of ASCVD events.
Number of participants using statin medication	Month 6	6-month assessment of statin prescription rates/dose

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States