Skip to main content
Clinical Trials/NCT04789278
NCT04789278
Unknown
Not Applicable

Incidental Coronary Calcification Quality Improvement Project

Stanford University1 site in 1 country173 target enrollmentMarch 30, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atherosclerotic Cardiovascular Disease
Sponsor
Stanford University
Enrollment
173
Locations
1
Primary Endpoint
Rate of Statin Prescription
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 30, 2021
End Date
September 15, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alexander Sandhu

Principal Investigator, Instructor of Medicine, Division of Cardiology

Stanford University

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)
  • Metastatic cancer or active cancer undergoing chemotherapy
  • History of medical nonadherence

Outcomes

Primary Outcomes

Rate of Statin Prescription

Time Frame: Within 6 months

Proportion of patients prescribed a statin

Secondary Outcomes

  • 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)
  • HDL Cholesterol Level(6 months)
  • Rate of Aspirin Prescription(6 months)
  • 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)

Study Sites (1)

Loading locations...

Similar Trials