Clinical trial NCT04789278: Incidental Coronary Calcification Quality Improvement Project
Official title: Incidental Coronary Calcification Quality Improvement Project
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atherosclerotic Cardiovascular Disease
Coronary Artery Disease
Keywords: Coronary Calcium
Statin
Non-gated Chest CT
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of Statin Prescription
timeFrame: Within 6 months
Secondary outcomes:
measure: Statin Intensity
timeFrame: 6 months
measure: Total Cholesterol Level
timeFrame: 6 months
measure: LDL Cholesterol Level
timeFrame: 6 months
measure: HDL Cholesterol Level
timeFrame: 6 months
measure: Triglyceride Level
timeFrame: 6 months
measure: Systolic Blood Pressure
timeFrame: 6 months
measure: Number of Hypertension Medications
timeFrame: 6 months
measure: Hemoglobin A1c Level
timeFrame: 6 months
measure: Body Mass Index
timeFrame: 6 months
measure: Pooled cohort equations estimated 10-year risk of atherosclerotic cardiovascular disease
timeFrame: 6 months
measure: Rate of Aspirin Prescription
timeFrame: 6 months
measure: Number of primary Care Clinical Encounters
timeFrame: 6 months
measure: Number of Cardiology Referrals
timeFrame: 6 months
measure: Number of Cardiovascular Diagnostic Tests
timeFrame: 6 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Hospital & Clinics
state: California
Study officials:
affiliation: Stanford University
name: Alexander T Sandhu, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: