Status:
NOT_YET_RECRUITING
NOrthwestern Tempus AI-enaBLed Electrocardiography (NOTABLE) Trial
Lead Sponsor:
Northwestern University
Conditions:
Atrial Fibrillation
Cardiovascular Diseases
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to determine if a machine learning/artificial intelligence (AI)-based electrocardiogram (ECG) algorithm (Tempus Next software) can identify undiagnosed cardiovascula...
Detailed Description
There is a large burden of undiagnosed, treatable cardiovascular disease (CVD), encompassing various heart conditions such as arrhythmias (e.g., atrial fibrillation) and structural heart diseases (e.g...
Eligibility Criteria
Inclusion
- Atrial fibrillation algorithm
- Age 65 or over
- ECG obtained as part of routine clinical care
- Structural heart disease algorithm
- Age 40 or over
- ECG obtained as part of routine clinical care
Exclusion
- Atrial fibrillation algorithm
- No history of AF
- No permanent pacemaker (PPM) or implantable cardioverter defibrillator (ICD)
- No recent cardiac surgery (within the preceding 30 days)
- Structural heart disease algorithm
- No history of SHD
- No echocardiogram within the past 1 year
Key Trial Info
Start Date :
August 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 3 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06511505
Start Date
August 3 2024
End Date
February 3 2026
Last Update
July 22 2024
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611