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

July 24, 2024 updated by: Tempus AI
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Corewell Health
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • TriHealth
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive-predictive value (PPV) of the AF device at six months
Time Frame: 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.
12 months
Positive-predictive value (PPV) of the SHD device at six months
Time Frame: 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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive-predictive value (PPV) of the AF device at 12 months
Time Frame: 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.
18 months
Positive-predictive value (PPV) of the SHD device at 12 months
Time Frame: 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
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tempus AI

Investigators

  • Principal Investigator: John Pfeifer, MD, Tempus AI, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2022

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

June 28, 2022

First Submitted That Met QC Criteria

June 28, 2022

First Posted (Actual)

July 1, 2022

Study Record Updates

Last Update Posted (Actual)

July 25, 2024

Last Update Submitted That Met QC Criteria

July 24, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMPS-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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