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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05858879
Acronym
NOTIFY-ASCVD
Enrollment
233
Registered
2023-05-15
Start date
2024-10-22
Completion date
2026-03-24
Last updated
2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ASCVD, Coronary Artery Calcification

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.

Interventions

OTHERNotification 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 (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.

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Masking description

In the usual care arm, patients or clinicians will not be notified.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Initiation of lipid-lowering therapyMonth 6Number of patients who had initiation of lipid-lowering therapy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026