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

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Calcification; ASCVD
• Intervention / Treatment: Other: Notification of patients and clinicians

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 Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fahim Abbasi, MD; Phone Number: 650-624-0954; Email: fahim@stanford.edu
• Study Contact Backup: Name: Sarah Magee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Usual care	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.
Active Comparator: Notification with a CAC image; Notification of presence of CAC with a CT scan image	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.
Active Comparator: Notification without a CAC image; Notification of presence of CAC without a CT scan image	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initiation of lipid-lowering therapy	Number of patients who had initiation of lipid-lowering therapy	Month 6

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Fatima Rodriguez, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 5, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Atherosclerosis
• Other Study ID Numbers: 70362

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No