Incidental Coronary Calcification Quality Improvement Project (ICC QI)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Atherosclerotic Cardiovascular Disease
• Intervention / Treatment: Other: Notification

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94066
      • Stanford Hospital & Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Notification; Patients randomized to notification will receive a message sent by either the electronic health record (EHR) patient portal or postal mail that will inform them of the CAC identified on their previous chest CT. It will provide an overview of CAC, an image of their chest CT, and a recommendation that they discuss this finding with their clinician. These clinicians will be notified of these findings via an earlier EHR message. Any treatment decisions will be made by the patient and their clinician. Patients randomized to notification who are not prescribed a statin medication and do not have a documented discussion regarding statin therapy within three months will be sent a second message at that time. Their primary care providers will receive a second EHR message concurrently.	Other: Notification; Notification of coronary calcium to the patient and their clinician
No Intervention: Usual Care; Both arms have previously had their CT scans reported according to standard clinical practice. This may include notification of the CAC in the imaging report. The usual care arm will not receive any additional notification beyond this standard of care during the project.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Statin Prescription	Proportion of patients prescribed a statin	Within 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Alexander T Sandhu, MD, MS, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2021
• Primary Completion (Actual): January 15, 2022
• Study Completion (Anticipated): September 15, 2022

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Statin; Coronary Calcium; Non-gated Chest CT
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Cardiovascular Diseases; Atherosclerosis
• Other Study ID Numbers: ICC-QI-2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No