Stanford, California 94066

  • Coronary Artery Disease

Purpose:

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.


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


Study is Available At:


Original ID:

ICC-QI-2021


NCT ID:

NCT04789278


Secondary ID:


Study Acronym:

ICC QI


Brief Title:

Incidental Coronary Calcification Quality Improvement Project


Official Title:

Incidental Coronary Calcification Quality Improvement Project


Overall Status:

Enrolling by invitation


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Stanford University


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

200


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Alexander T Sandhu, MD, MS
Principal Investigator
Stanford University

Study Dates

Start Date:March 30, 2021
Completion Date:June 15, 2022
Completion Type:Anticipated
Primary Completion Date:January 15, 2022
Primary Completion Type:Anticipated
Verification Date:April 2021
Last Changed Date:April 2, 2021
First Received Date:February 26, 2021

Study Outcomes

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

Study Interventions

Intervention Type:Other
Name:Notification
Description:Notification of coronary calcium to the patient and their clinician
Arm Name:Notification

Study Arms

Study Arm Type:No Intervention
Arm Name:Usual Care
Description: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.
Study Arm Type:Experimental
Arm Name:Notification
Description: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

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Stanford University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 26, 2021

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