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

Not Applicable

• Conditions: ASCVD; Coronary Artery Calcification
• Interventions: Other: Notification of patients and clinicians

• Registration Number: NCT05858879
• Lead Sponsor: Stanford University

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-05-05
• Study First Submitted QC: 2023-05-05
• Study First Posted: 2023-05-15
• Study Start: 2024-10-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Presence of CAC on non-gated chest CT scans performed from 2021 to 2023

2. Age <85 years

3. Diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease

4. Visit to Stanford affiliated clinician since 2021 at one of the following Stanford clinics including University affiliated clinics:

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Notification without a CAC image	Notification of patients and clinicians	Notification of presence of CAC without a CT scan image
Notification with a CAC image	Notification of patients and clinicians	Notification of presence of CAC with a CT scan image
Usual care	Notification of patients and clinicians	Usual care

Primary Outcome Measures

Name	Time	Method
Initiation of lipid-lowering therapy	Month 6	Number of patients who had initiation of lipid-lowering therapy

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States