Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease

Last updated: July 24, 2024
Sponsor: Tempus AI
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Chest Pain

Cardiac Disease

Arrhythmia

Treatment

Zio Patch Monitor

Echocardiogram

Clinical Study ID

NCT05442203
TMPS-201
  • Ages > 40
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofthe 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 ofstudy recruitment

  • Patient is able to identify a licensed healthcare provider to receive the results ofthe echocardiogram.

Exclusion

Exclusion Criteria:

  • Retrospective Phase:

  • Patients who have previously requested that their data not be involved in anysecondary use application such as a research study.

  • Prospective Phase:

  • AF Cohort:

  • Any clinical or social factor that would prohibit completing the follow-up studiesin 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 studiesin 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, severetricuspid regurgitation, moderate or severe aortic stenosis, moderate or severeaortic regurgitation, moderate or severe mitral stenosis, left ventricular systolicdysfunction (LVEF ≤ 40%), or increased septal wall thickness > 15 mm.

  • Allergy to ultrasound gel.

Study Design

Total Participants: 1000
Treatment Group(s): 2
Primary Treatment: Zio Patch Monitor
Phase:
Study Start date:
September 07, 2022
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • Corewell Health

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • TriHealth

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Geisinger Medical Center

    Danville, Pennsylvania 17822
    United States

    Site Not Available

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