Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease

Study Overview
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Brief Summary
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Atrial fibrillation is an abnormal beating of the heart that can lead to stroke or heart failure. Structural heart diseases are conditions that affect the heart valves or heart muscle and can cause permanent heart damage if left untreated. Sometimes people have atrial fibrillation or structural heart disease and do not know it. The purpose of this study is to evaluate two devices that can predict who has or may develop atrial fibrillation or structural heart disease based on the results of an electrocardiogram.

Official Title
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Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease

Conditions
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Atrial Fibrillation, Structural Heart Disease

Intervention / Treatment
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* Device: Zio Patch Monitor
* Device: Echocardiogram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Retrospective Phase: Adults aged 40 or older. At least 1 ECG obtained during routine clinical care. Prospective Phase: AF Cohort: Adults aged 65 or older at the time of ECG. ECG obtained as part of a clinical care. Patient is able to identify a licensed healthcare provider to receive the results of the patch monitor. SHD Cohort: Adults aged 40 or older at the time of the ECG. ECG obtained as part of a clinical care between study start date and the end of study recruitment Patient is able to identify a licensed healthcare provider to receive the results of the echocardiogram. Exclusion Criteria: Retrospective Phase: Patients who have previously requested that their data not be involved in any secondary use application such as a research study. Prospective Phase: AF Cohort: Any clinical or social factor that would prohibit completing the follow-up studies in a timely fashion. Patient currently admitted to the hospital (at time of consent) Permanent pacemaker or implanted cardiac defibrillator or implanted loop recorder. History of atrial fibrillation or atrial flutter. Cardiac surgery within 30 days prior to the index ECG Cardiac surgery planned within the next 6 months. Allergy to adhesive. SHD Cohort: Any clinical or social factor that would prohibit completing the follow-up studies in a timely fashion. Patient currently admitted to the hospital (at time of consent). History of SHD defined as any of the following: severe mitral regurgitation, severe tricuspid regurgitation, moderate or severe aortic stenosis, moderate or severe aortic regurgitation, moderate or severe mitral stenosis, left ventricular systolic dysfunction (LVEF ≤ 40%), or increased septal wall thickness > 15 mm. Allergy to ultrasound gel.

Ages Eligible for Study
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Minimum Age: 40 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: AF Cohort<br>Will be comprised of 500 participants predicted to be increased risk for Atrial Fibrillation (AF) will receive a 2-week ECG patch monitor to wear (up to 3 times over 12 months), | Device: Zio Patch Monitor<br>* Patch monitor will be applied and worn for a 2-week period at baseline, month 6, and month 12 after assignment to the AF arm.<br>|
| Other: SHD Cohort<br>Will be comprised 500 participants at increased risk for Structural Heart Disease (SHD) will be referred for a single echocardiogram. | Device: Echocardiogram<br>* Ultrasound study of the heart will be completed upon patient consent after assignment to the SHD arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive-predictive value (PPV) of the AF device at six months | AF will be defined by findings from the patch monitor, participant interview or the EHR-based phenotype definition and will be considered positive if a diagnosis occurs within 6 months of the index ECG. | 12 months | 
| Positive-predictive value (PPV) of the SHD device at six months | Structural heart disease will be defined as: moderate or severe mitral stenosis, aortic regurgitation, or aortic stenosis severe mitral or tricuspid regurgitation LVEF ≤ 40% Interventricular septal thickness >15mm | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive-predictive value (PPV) of the AF device at 12 months | AF will be defined by findings from the patch monitor, participant interview or the EHR-based phenotype definition and will be considered positive if a diagnosis occurs within 12 months of the index ECG. | 18 months | 
| Positive-predictive value (PPV) of the SHD device at 12 months | Structural heart disease will be defined as: moderate or severe mitral stenosis, aortic regurgitation, or aortic stenosis severe mitral or tricuspid regurgitation LVEF ≤ 40% Interventricular septal thickness >15mm | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Disease, Structural Heart Disease, Machine Learning, Electrocardiogram, Atrial Fibrillation