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

Stanford University

Status: Active, not recruiting

Conditions: Coronary Artery Calcification; ASCVD

Treatments: Other: Notification of patients and clinicians

Study type: Interventional

Funder types: Other

Identifiers

NCT05858879

70362

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 233 patients

Sex: All

Ages: 18 to 84 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Presence of CAC on non-gated chest CT scans performed from 2021 to 2025

2. Age <85 years

3. Diagnosis of ASCVD(coronary artery disease, peripheral artery disease, or cerebrovascular disease)

4. Visit to Stanford affiliated clinician since 2022 at one of the following Stanford clinics including University affiliated clinics:

   1. Internal Medicine
   2. Family Medicine
   3. Cardiology
   4. Neurology
   5. Vascular surgery

5. Primary language is English or Spanish

Exclusion criteria

1. No diagnosis of ASCVD
2. Patients receiving lipid-lowering therapy
3. Dementia
4. Metastatic cancer or active cancer undergoing chemotherapy
5. Hospice

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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233 participants in 3 patient groups

Notification with a CAC image

Experimental group

Description:

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

Treatment:

Other: Notification of patients and clinicians

Notification without a CAC image

Experimental group

Description:

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

Treatment:

Other: Notification of patients and clinicians

Usual care

No Intervention group

Description:

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.