Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease
Status unconfirmed · Not applicable
Conditions studied: Atrial Fibrillation, Structural Heart Disease
In brief
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.
Key facts
- Study ID
- NCT05442203
- Run by
- Tempus AI
- People needed
- 1000
- Starts
- 2022-09-07
- Expected to finish
- 2025-07-01
- Last updated by the study team
- 2024-07-25
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Corewell Health — Grand Rapids, Michigan, United States
- TriHealth — Cincinnati, Ohio, United States
- Geisinger Medical Center — Danville, Pennsylvania, United States
Full record on ClinicalTrials.gov
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