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

Stanford University

Status: Active, not recruiting

Conditions: Coronary Artery Calcification

Treatments: Other: Notification

Study type: Interventional

Funder types: Other

Identifiers

NCT05588895

67227

Details and patient eligibility

About

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.

Enrollment: 202 patients

Sex: All

Ages: 18 to 84 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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202 participants in 2 patient groups

Notification

Experimental group

Description:

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.

Treatment:

Other: Notification

Usual Care

No Intervention group

Description:

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.