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

Stanford University

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Other: Notification

Study type: Interventional

Funder types: Other

Identifiers

NCT05394181

64798

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Notification

Experimental group

Description:

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

Treatment:

Other: Notification

Usual Care

No Intervention group