Notification of Incidental Coronary Artery Calcium in Patients With Atherosclerotic Cardiovascular Disease (NOTIFY-ASCVD)

NCT05858879 | Completed

• 1 other identifier: 70362
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 1

Brief Summary

Estimate the impact of notifying both patients and their clinicians of the presence of incidental coronary artery calcium (CAC) on initiation of lipid-lowering therapy in patients with ASCVD who are not receiving lipid-lowering therapy.

Conditions

ASCVD; Coronary Artery Calcification

Outcome Measures

Primary Outcomes (1)

• Initiation of lipid-lowering therapy

  Number of patients who had initiation of lipid-lowering therapy

  Month 6

Study Arms (3)

Notification with a CAC image

EXPERIMENTAL

Notification of presence of CAC with a CT scan image and the ACC/AHA guideline recommendation for initiation of lipid-lowering therapy.

Other: Notification of patients and clinicians

Notification without a CAC image

EXPERIMENTAL

Notification of presence of CAC without a CT scan image and the ACC/AHA guideline recommendation for initiation of lipid-lowering therapy.

Other: Notification of patients and clinicians

Usual care

NO INTERVENTION

The usual care arm will not receive any additional notification beyond the standard of care. If the intervention is successful, we will notify patients in the usual care arm of the presence of CAC and the ACC/AHA guideline recommendation for initiation of lipid-lowering therapy.

Interventions

Notification of patients and clinicians OTHER

Notification Patients randomized to notification will receive a message sent by either the electronic health record (EHR) patient portal or US mail that will inform them of the CAC identified on their previous chest CT scan (with or without an image) and a recommendation that they discuss this finding and initiation of lipid-lowering therapy with their clinician. The clinicians will be notified of these findings by an earlier EHR message that will be sent 2 weeks before the patient notification. Two months after the initial notification, patients and their clinicians who are randomized to notification arms will receive a second message similar to the initial notification.

Notification with a CAC image; Notification without a CAC image

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of CAC on non-gated chest CT scans performed from 2021 to 2025
• Age \<85 years
• Diagnosis of ASCVD(coronary artery disease, peripheral artery disease, or cerebrovascular disease)
• Visit to Stanford affiliated clinician since 2022 at one of the following Stanford clinics including University affiliated clinics:
• Internal Medicine
• Family Medicine
• Cardiology
• Neurology
• Vascular surgery
• Primary language is English or Spanish

You may not qualify if:

• No diagnosis of ASCVD
• Patients receiving lipid-lowering therapy
• Dementia
• Metastatic cancer or active cancer undergoing chemotherapy
• Hospice

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: In the usual care arm, patients or clinicians will not be notified.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine (Cardiovascular Medicine)

Model Details: Eligible patients will be randomized to: 1) notification of presence of CAC with a CT scan image; 2) notification of presence of CAC without a CT scan image; 3) or usual care.

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 15, 2023
• Study Start: October 22, 2024
• Primary Completion: March 24, 2026
• Study Completion: March 24, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)