Incidental Coronary Calcification Quality Improvement Project

Not Applicable

• Conditions: Coronary Artery Disease; Atherosclerotic Cardiovascular Disease

• Registration Number: NCT04789278
• Lead Sponsor: Stanford University

Brief Summary

This is a multi-center, randomized quality improvement project. At least 200 statin-naïve patients without a history of atherosclerotic cardiovascular disease with incidental coronary artery calcium (CAC) on a prior non-gated chest CT will be enrolled across the Stanford Healthcare System and the Palo Alto Veteran's Affairs Healthcare System. Patients will be randomized in a 1:1 fashion to notification or usual care arms. The primary aim of this project is to estimate the increase in 6-month statin prescription among statin-naïve patients without a history of atherosclerotic cardiovascular disease with incidental CAC on a non-gated chest CT who are randomized to receive notification of their findings vs. usual care.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-03-04
• Study First Posted: 2021-03-09
• Study Start: 2021-03-30
• Primary Completion: 2022-01-15
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-29
• Study Completion: 2022-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

• Non-gated chest CT between 2014-2019
• The presence of CAC confirmed by manual review by an experienced radiologist
• Stanford affiliated primary care provider or endocrinologist for Stanford healthcare system patients and VA primary care provider for VA patients with at least 1 encounter since 2018

Exclusion Criteria

• Current or prior statin or PCSK9 inhibitor therapy
• Prior diagnosis of ASCVD (coronary artery disease, peripheral arterial disease, cerebrovascular disease, coronary/peripheral revascularization)
• Prior coronary imaging (cardiac CT, invasive coronary angiography)
• Dementia
• Metastatic cancer or active cancer undergoing chemotherapy
• History of medical nonadherence

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of Statin Prescription	Within 6 months	Proportion of patients prescribed a statin

Secondary Outcome Measures

Name	Time	Method
Number of primary Care Clinical Encounters	6 months
Number of Cardiology Referrals	6 months
LDL Cholesterol Level	6 months
Systolic Blood Pressure	6 months
Hemoglobin A1c Level	6 months
Statin Intensity	6 months	Proportion of patients prescribed a high intensity, intermediate intensity, and low intensity statin
HDL Cholesterol Level	6 months
Rate of Aspirin Prescription	6 months	Proportion of patients prescribed aspirin
Total Cholesterol Level	6 months
Number of Cardiovascular Diagnostic Tests	6 months
Triglyceride Level	6 months
Number of Hypertension Medications	6 months
Body Mass Index	6 months
Pooled cohort equations estimated 10-year risk of atherosclerotic cardiovascular disease	6 months

Trial Locations

Locations (1)

Stanford Hospital & Clinics; 🇺🇸 Stanford, California, United States