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

Coronary Artery Calcification Clinical Trial

— NOTIFY-ASCVD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05858879
• Other study ID #: 70362
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: February 2025

Study information

• Verified date: June 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: February 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• ASCVD
• Atherosclerosis
• Cardiovascular Diseases
• Coronary Artery Calcification

Intervention

Other:
• Notification of patients and clinicians
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 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. Usual Care The usual care arm will not receive any additional notification beyond this standard of care.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initiation of lipid-lowering therapy	Number of patients who had initiation of lipid-lowering therapy	Month 6