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

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 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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Calcification
• Intervention / Treatment: Other: Notification

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shiqin Xu; Phone Number: 919-412-1939; Email: shiqinxu@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University
      • Contact: Fatima Rodriguez; Phone Number: 650-497-0881; Email: frodrigu@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 87 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 at the end of 6 months if we determine that notification is effective at increasing statin rates.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of new statin prescriptions or increased dose prescriptions	6-month new statin prescription rate or increase in dosage if baseline statin use	Baseline through Month 6

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Fatima Rodriguez, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

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): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Calcium Metabolism Disorders; Calcinosis
• 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