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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05588895
Other study ID # 67227
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date January 8, 2024
Est. completion date December 2024

Study information

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

Clinical Trial Summary

This is a prospective randomized controlled trial assessing the impact of notifying patients and their clinicians of an incidental finding of coronary artery calcification (CAC) indicating increased cardiovascular risk. Patients will be identified through completed radiology orders for non-gated, non-contrast chest CT in the appropriate clinical context and then will have an EHR screen for inclusion criteria. The presence of CAC will be confirmed by a board-certified physician. Eligible patients will be randomized to CAC notification or usual care using a 1:1 stratified block randomization method based on baseline statin use.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 300
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 84 Years
Eligibility Inclusion Criteria: - Age 18 and above and <85 - Non-gated chest CT with CAC - An encounter after July 1, 2021 with a Stanford-affiliated clinician from one of the following clinics: - Stanford Internal Medicine (includes University affiliated clinics) - Stanford Family Medicine (includes University affiliated clinics) - Non-EP cardiologist Exclusion Criteria: - Advanced or poor-prognostic cancer - No active primary care or cardiology care at Stanford Health Care - Primary language other than English, Spanish, Vietnamese, Cantonese, or Mandarin - Baseline statin or non-statin lipid lowering therapy - Allergy to statin medication or identification of statin-associated muscle symptom

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Notification
For patients randomized to notification, the affiliated non-EP cardiologist, if present, or if patient does not have one, the PCP will be notified and will receive an electronic health record (EHR) message notifying them of the presence of CAC (with images) and the ACC/AHA guideline recommendation to consider starting statin therapy. Simultaneously, the patient will be notified via a MyHealth message describing the presence of CAC with personalized scan images, its significance, and the recommendation that statin therapy should be considered. For the notification arm, we will check for either statin prescription or a documented discussion in the EHR at 2 months. For those not prescribed a statin and without a documented discussion in Epic at 2 months follow-up, we will send a repeat notification to their home address and to their affiliated clinician.

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 Number of new statin prescriptions or increased dose prescriptions 6-month new statin prescription rate or increase in dosage if baseline statin use Baseline through Month 6
Secondary Number of participants using statin medication 6-month assessment of statin prescription rates/dose Month 6
Secondary Change in Low-density lipoprotein (LDL) cholesterol Baseline and Month 6
Secondary Change in 10-Year Atherosclerotic Cardiovascular Disease (ASCVD) Pooled Cohort Equation This outcome measures the 10 year risk of ASCVD events. Baseline and Month 6
Secondary Number of events requiring primary care intervention, cardiology referrals, or cardiac testing This outcome assesses healthcare resource use (primary care clinical encounters, cardiology referrals, cardiac testing). Baseline through Month 6
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