Incidental Coronary Calcification Quality Improvement Project

Coronary Artery Disease Clinical Trial

— ICC QI  

Official title:

Incidental Coronary Calcification Quality Improvement Project

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04789278
• Other study ID #: ICC-QI-2021
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 30, 2021
• Est. completion date: September 15, 2022

Study information

• Verified date: July 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 173
• Est. completion date: September 15, 2022
• Est. primary completion date: January 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases
• Coronary Artery Disease

Intervention

Other:
• Notification
Notification of coronary calcium to the patient and their clinician

Locations

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