Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease

Recruitment & Eligibility

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.

Study & Design

Arm && Interventions

Group	Intervention	Description
SHD Cohort	Echocardiogram	Will be comprised 500 participants at increased risk for Structural Heart Disease (SHD) will be referred for a single echocardiogram.
AF Cohort	Zio Patch Monitor	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),

Primary Outcome Measures

Name	Time	Method
Positive-predictive value (PPV) of the SHD device at six months	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
Positive-predictive value (PPV) of the AF device at six months	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 6 months of the index ECG.

Secondary Outcome Measures

Name	Time	Method
Positive-predictive value (PPV) of the SHD device at 12 months	18 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
Positive-predictive value (PPV) of the AF device at 12 months	18 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.

Recruitment & Eligibility