AI-enabled ECG for Undiagnosed Heart Conditions (NOTABLE Trial)
This study, called NOTABLE, is testing a new artificial intelligence (AI) tool called Tempus Next software. This tool analyzes standard heart tests (electrocardiograms or ECGs) to see if it can help doctors find undiagnosed heart conditions like atrial fibrillation (an irregular heartbeat) and structural heart disease (problems with the heart's structure) earlier. The study wants to see if using this AI tool improves the detection of these conditions and how it affects patient care. Researchers will compare patients whose doctors use the AI tool to those whose doctors don't. The main goal is to see how many new heart diagnoses are made after 6 months.
- Study design
- This interventional study plans to enroll 1000 participants. It compares two groups of patients: those whose doctors use the AI-enabled ECG tool and those whose doctors do not.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at 6 months, indicating a follow-up period of at least 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NOrthwestern Tempus AI-enaBLed Electrocardiography (NOTABLE) Trial
At a glance
Conditions
NCT06511505
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Northwestern University
Chicago, Illinoisstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Sanjiv Shah, MD · PRINCIPAL_INVESTIGATOR · Northwestern University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Incidence of New Atrial Fibrillation Diagnosis6 months from index ECG
Number of participants with a new diagnosis of atrial fibrillation, identified by ICD-10-CM diagnosis code entry in the electronic health record (EHR), among patients ≥65 years old without a prior AF diagnosis who received a 12-lead ECG as part of routine clinical care.
- Incidence of New Structural Heart Disease Diagnosis (Composite)6 months from index ECG
Number of participants with a new diagnosis of one or more of the following, identified by ICD-10-CM diagnosis code and/or echocardiographic report in the EHR: moderate or severe aortic stenosis, moderate or severe aortic regurgitation, moderate or severe mitral stenosis, severe mitral regurgitation, severe tricuspid regurgitation, left ventricular ejection fraction ≤40%, or interventricular septal thickness (IVSd) \>15 mm - among patients ≥40 years old without prior SHD diagnosis who received a 12-lead ECG as part of routine clinical care.
- Incidence of New Cardiovascular Diagnosis (Overall Composite: AF + SHD)6 months from index ECG
Number of participants with a new diagnosis of atrial fibrillation and/or any structural heart disease component listed in Primary Outcome Measure 2, identified by ICD-10-CM diagnosis code and/or echocardiographic report in the EHR.