ECG-AID: Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease

Sponsor

Tempus Labs (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05442203

Collaborator

(none)

1,000

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Structural Heart Disease	Device: Zio Patch Monitor Device: Echocardiogram	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: AF Cohort 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 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.
Other: SHD Cohort Will be comprised 500 participants at increased risk for Structural Heart Disease (SHD) will be referred for a single echocardiogram.	Device: Echocardiogram Ultrasound study of the heart will be completed upon patient consent after assignment to the SHD arm.

Arm

Intervention/Treatment

Other: AF Cohort

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

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.

Other: SHD Cohort

Will be comprised 500 participants at increased risk for Structural Heart Disease (SHD) will be referred for a single echocardiogram.

Device: Echocardiogram

Ultrasound study of the heart will be completed upon patient consent after assignment to the SHD arm.

Outcome Measures

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Retrospective Phase:
Adults aged 40 or older.
At least 1 ECG obtained during routine clinical care prior to 2018.
Prospective Phase:
AF Cohort:
Adults aged 65 or older at the time of ECG.
ECG obtained as part of a clinical care between study start date and the end of study recruitment
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

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 unable to identify a licensed healthcare provider to receive the results of the patch monitor.
Patient currently admitted to the hospital (at time of contact/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 unable to identify a licensed healthcare provider to receive the results of the echocardiogram.
Patient currently admitted to the hospital (at time of contact/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.