Notify 2: An Evaluation of the Impact of Notification of Incidental Coronary Artery Calcium on Statin Rates

Not Applicable

• Conditions: Coronary Artery Disease
• Interventions: Other: Notification

• Registration Number: NCT05394181
• Lead Sponsor: Stanford University

Brief Summary

The primary objective is to estimate the impact of notification of primary care provider and patient of at least moderate incidental coronary artery calcification (CAC) on a prior non-gated chest CT on statin prescription rates at 4 months among patients without a clinical history of atherosclerotic cardiovascular disease not actively on statin therapy. This study will determine if notifying patients and their primary care clinician about an existing finding will influence shared decision-making around statins between patients and their primary care clinician.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-24
• Study First Submitted QC: 2022-05-24
• Last Update Submitted: 2022-05-24
• Study First Posted: 2022-05-27
• Last Update Posted: 2022-05-27
• Study Start: 2022-08-01
• Primary Completion: 2023-01-15
• Study Completion: 2023-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Age greater than or equal to 18 and less than 85
2. Non-gated chest CT from 1/1/2016-6/30/2020 with algorithm screening estimating CAC score of at least 100 Agatston Units with radiologist confirmation of moderate or severe CAC
3. Encounter with Palo Alto VA affiliated primary care since 2020

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Exclusion Criteria

1. Prior diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease
2. Dementia
3. Metastatic cancer or active cancer undergoing chemotherapy
4. CT coronary angiogram since 2016
5. Invasive Coronary angiogram since 2016
6. CAC scan since 2016
7. Statin therapy within prior 6 months
8. Prior ezetimibe or PCSK9 inhibitor therapy
9. Prior rhabdomyolysis with statin therapy
10. Schizophrenia
11. Substance abuse disorder (alcohol, amphetamines, cocaine, opioids)
12. Hospice
13. Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Notification	Notification	Notification of the presence of at least moderate coronary artery calcium on a prior non-gated chest CT

Primary Outcome Measures

Name	Time	Method
Statin prescription rate	4 months	Prescription of statin medication

Trial Locations

Locations (1)

Palo Alto Veteran's Affairs Hospital; 🇺🇸 Palo Alto, California, United States