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

Coronary Artery Calcification Clinical Trial

— PICTURE  

Official title:

NOTIFY 2: Picture of Incidental Calcium To Understand Risk Estimate

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05588895
• Other study ID #: 67227
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: Shiqin Xu
• Phone: 919-412-1939
• Email: shiqinxu[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Calcinosis
• Coronary Artery Calcification

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants using statin medication	6-month assessment of statin prescription rates/dose	Month 6
Secondary	Change in Low-density lipoprotein (LDL) cholesterol		Baseline and Month 6
Secondary	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
Secondary	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