Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Tempus AI
- Enrollment
- 1,000
- Locations
- 3
- Primary Endpoint
- Positive-predictive value (PPV) of the SHD device at six months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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),
Intervention: Zio Patch Monitor (Device)
SHD Cohort
Will be comprised 500 participants at increased risk for Structural Heart Disease (SHD) will be referred for a single echocardiogram.
Intervention: Echocardiogram (Device)
Outcomes
Primary Outcomes
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
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.
Secondary Outcomes
- Positive-predictive value (PPV) of the AF device at 12 months(18 months)
- Positive-predictive value (PPV) of the SHD device at 12 months(18 months)