Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease

Atrial Fibrillation Clinical Trial

— ECG-AID  

Official title:

Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05442203
• Other study ID #: TMPS-201
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2022
• Est. completion date: September 2024

Study information

• Verified date: January 2024
• Source: Tempus AI
• Contact: ECG-AID Study
• Phone: 833-514-4187
• Email: ecg-aid-study[@]tempus.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Diseases
• Structural Heart Disease

Intervention

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

Locations

Country	Name	City	State
United States	TriHealth	Cincinnati	Ohio
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Corewell Health	Grand Rapids	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Tempus AI

Country where clinical trial is conducted

United States, 

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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