NOTIFY (New Observations Taking Information From Yesterday)

Study Overview
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Brief Summary
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This trial will investigate whether notifying patients and their clinicians of the presence of moderate or severe coronary artery calcium on a low-dose CT scan performed for lung cancer screening results in a lower incidence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke as compared with usual care informed by clinical practice guidelines.

Official Title
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NOTIFY (New Observations Taking Information From Yesterday)

Conditions
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Atherosclerotic Cardiovascular Disease

Intervention / Treatment
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* Other: Notification of CAC
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 50-84 years No known ASCVD Lung cancer screenee with low dose CT scan (LDCT) within the last 5 years Coronary artery calcium (CAC) score on LDCT >100 Agatston units (AU) Not taking a statin or other lipid-lowering therapy (e.g., ezetimibe, bempedoic acid, or PCSK9-lowering therapy) Exclusion Criteria: Dementia or other neuropsychiatric disorder that interferes with medication adherence CAC scan, coronary CT angiogram, or invasive angiogram since LDCT Statin medication intolerance or allergy Life expectancy <2 years, e.g., metastatic cancer or active cancer undergoing chemotherapy

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Notification of CAC<br>For patients randomized to the notification of CAC arm (NC), primary clinicians will be notified that with the assistance of a deep-learning algorithm, one of their patients was found to have a CAC score >100 AU. The notification will include an image taken from the CT scan with CAC clearly marked. The notification will also include American Heart Association/American College of Cardiology 2a recommendation to initiate lipid lowering therapy (usually statin) given the presence of moderate-severe CAC. Patients randomized to notification will receive messages (via EHR portal-based messages, text, or US postal mail) with notification of CAC presence on their LDCT, images showing the presence of CAC from their previous chest CT clearly marked, the recommendation to discuss statin or other lipid-lowering therapy with their clinician, and a link to a patient-friendly website about CAC and risk factor control. There will be reminder messages sent at 3 weeks and 12 months. | Other: Notification of CAC<br>* Provider and patient are notified of coronary artery calcium present on patient's CT scan. Notification includes a personalized image of CAC from the patient's CT scan performed for lung cancer screening.<br>|
| Other: Usual Care<br>Patients randomized to Usual Care will receive usual medical care provided by their clinician informed by widely publicized clinical practice guidelines. | Other: Usual Care<br>* Patients randomized to Usual Care will receive usual medical care provided by their clinician informed by widely publicized clinical practice guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke |  | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of All-cause Death | Number (%) of participants in each treatment group with death from any cause. | 6 years | 
| Rate of Cardiovascular Death | Number (%) of participants in each treatment group with cardiovascular death | 6 years | 
| Rate of Nonfatal Myocardial Infarction | Number (%) of participants in each treatment group with nonfatal myocardial infarction | 6 years | 
| Rate of Nonfatal Stroke | Number (%) of participants in each treatment group with nonfatal stroke | 6 years | 
| Initial lipid-lowering therapy prescription rate | Number (%) of participants in each treatment group with active prescriptions of lipid-lowering therapy at 6 months following randomization | within 6 months of 1st notification | 
| Number of Participants with active lipid-lowering therapy prescriptions | Persistence of need for lipid-lowering therapy at 18 months following randomization. | At 18 months | 
| Number of revascularization procedures (PCI, CABG, carotid artery revascularization, or peripheral artery revascularization) | Number of revascularization procedures (PCI, CABG, carotid artery revascularization, or peripheral artery revascularization) | 6 years |