Artificial Intelligence Enhanced ECG to Detect Cardiac Amyloidosis

Study Overview
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Brief Summary
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The purpose of this study is to assess a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis of cardiac amyloidosis (CA).

Detailed Description
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This pragmatic trial will be the first study to prospectively evaluate the use of the AI ECG dashboard along with an augmented report in everyday practice. The findings will also guide future implementation strategies and inform the translation of many of the current and future AI algorithms into the clinical setting. The participants are the providers. Basic demographic information about the providers will be collected as well as their reactions to the trial based educational guidance supplied to them. Patient health information will be collected on their patients using a HIPPA waiver. There will be no patient contact.

Official Title
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Artificial Intelligence Enhanced ECG to Detect Cardiac Amyloidosis: Protocol for a Pragmatic Cluster Randomized Clinical Trial (PREDICT-AMY)

Conditions
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Cardiac Amyloidosis

Intervention / Treatment
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* Other: AI ECG Amyloid algorithm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mayo Clinic cardiology or hematology providers who care for adult patients Mayo Clinic providers who consent to participate on this study Exclusion Criteria: - None

Ages Eligible for Study
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Minimum Age: 18 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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Notification of the AI ECG algorithm and the A3E scores<br>Provider-facing recommendation report that alerts to provider for positive AI ECG Amyloid Score, standardized amyloid order set, diagnostic algorithm and reminders | Other: AI ECG Amyloid algorithm<br>* Artificial intelligence enabled electrocardiogram screening tool used to identify the predictive model that best differentiates those at greatest risk for an amyloidosis diagnosis<br>|
| No Intervention: Usual Care<br>No alerts to provider for positive AI ECG Amyloid Score, standardized amyloid order set, diagnostic algorithm and reminders | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if AI ECG algorithm and enhanced algorithms and education enable earlier diagnosis of cardiac amyloidosisProtocol for a Pragmatic Cluster Randomized Clinical Trial (PREDICT-AMY) | The number of patients diagnosed with cardiac amyloidosis in cardiology and hematology practices will be compared between those providers undergoing the AI ECG intervention to those randomized to standard practice arm | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if AI ECG and enhanced algorithms and education enable earlier diagnosis of cardiac amyloidosis intervention across different practice types (strata) | Performance of AI ECG intervention across cardiology and hematology practices and between community and tertiary facilities will be analyzed by measuring rates of cardiac amyloidosis diagnosis across these strata | 1 year | 
| To assess provider satisfaction with the AI ECG intervention | For a screening tool to be effective, it has to be user friendly. The providers randomized to the AI ECG intervention arm will be surveyed to understand their experience. This endpoint will be descriptive. Providers will answer a 6 question using a 5-point Likert scale (higher number is more favorable). | 1 year | 
| To assess differential costs between the intervention arm and the standard of care arm | Upon trial completion, the difference in clinical expenditures between the intervention and standard of care arms will be compared. To this end, the rates of test ordering will be counted and compared between the interventional arm and the standard of care arm. A cost will be assigned to each test to calculate expenditures per correct diagnosis. The test of interest will include: NT-proBNP, troponin, protein electrophoresis with isotyping, serum immunoglobulin free light chains, 24-hour urinary protein with immunofixation, cardiac magnetic resonance imaging, echocardiogram, technetium pyrophosphate nuclear cardiac scintigraphy , endomyocardial biopsy, and fat aspirate. | 1 year |