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NCT Number: NCT05442203

Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Structural Heart Disease

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Corewell Health, Grand Rapids, Michigan, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zio Patch Monitor

Device

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

Device

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

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Tempus AI

Industry

Registry information

Acronym: ECG-AID

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 1, 2022
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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