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Incidental Coronary Calcification Quality Improvement Project

Incidental Coronary Calcification Quality Improvement Project

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04789278
Acronym
ICC QI
Enrollment
173
Registered
2021-03-09
Start date
2021-03-30
Completion date
2022-09-15
Last updated
2022-07-29

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

Conditions

Atherosclerotic Cardiovascular Disease, Coronary Artery Disease

Keywords

Coronary Calcium, Statin, Non-gated Chest CT

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.

Interventions

Notification of coronary calcium to the patient and their clinician

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of Statin PrescriptionWithin 6 monthsProportion of patients prescribed a statin

Secondary

MeasureTime frameDescription
Statin Intensity6 monthsProportion of patients prescribed a high intensity, intermediate intensity, and low intensity statin
Total Cholesterol Level6 months
LDL Cholesterol Level6 months
HDL Cholesterol Level6 months
Triglyceride Level6 months
Systolic Blood Pressure6 months
Number of Hypertension Medications6 months
Hemoglobin A1c Level6 months
Body Mass Index6 months
Pooled cohort equations estimated 10-year risk of atherosclerotic cardiovascular disease6 months
Rate of Aspirin Prescription6 monthsProportion of patients prescribed aspirin
Number of primary Care Clinical Encounters6 months
Number of Cardiology Referrals6 months
Number of Cardiovascular Diagnostic Tests6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026