An interventional study of Notification in Atherosclerotic Cardiovascular Disease and Coronary Artery Disease, sponsored by Stanford University. Status unknown at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-07-29.
Sponsored by Stanford University · Not applicable, Interventional, and Other
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.
This study's enrollment of 173 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Notification of coronary calcium to the patient and their clinician
Rate of Statin Prescription
Proportion of patients prescribed a statin
Time frame: Within 6 months
Statin Intensity
Proportion of patients prescribed a high intensity, intermediate intensity, and low intensity statin
Time frame: 6 months
Total Cholesterol Level
Time frame: 6 months
LDL Cholesterol Level
Time frame: 6 months
HDL Cholesterol Level
Time frame: 6 months
Triglyceride Level
Time frame: 6 months
Systolic Blood Pressure
Time frame: 6 months
Number of Hypertension Medications
Time frame: 6 months
Hemoglobin A1c Level
Time frame: 6 months
Body Mass Index
Time frame: 6 months
Pooled cohort equations estimated 10-year risk of atherosclerotic cardiovascular disease
Time frame: 6 months
Rate of Aspirin Prescription
Proportion of patients prescribed aspirin
Time frame: 6 months
Number of primary Care Clinical Encounters
Time frame: 6 months
Number of Cardiology Referrals
Time frame: 6 months
Number of Cardiovascular Diagnostic Tests
Time frame: 6 months
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This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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