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

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.

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Key information

Conditions

ASCVD Coronary Artery Calcification

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94304, United States

About this study

This is a randomized quality improvement (QI) project evaluating the impact of notifying patients and their clinicians (primary care, cardiologists, neurologists, or vascular surgeon) of incidental CAC detected on a prior chest CT scan. Patients will be identified by screening previous non-gated chest CT scans and electronic health records. The presence of CAC will be confirmed by a radiologist. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

Initiation of lipid-lowering therapy

Time frame: Month 6

Number of patients who had initiation of lipid-lowering therapy

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Acronym: NOTIFY-ASCVD

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: May 15, 2023
Registry last updated: Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed