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NCT06511505Recruiting

NOrthwestern Tempus AI-enaBLed Electrocardiography (NOTABLE) Trial

NOrthwestern Tempus AI-enaBLed Electrocardiography (NOTABLE) Trial: A Pragmatic, Real-world Study of an Artificial-intelligence Enabled Electrocardiogram Algorithms to Improve the Diagnosis of Cardiovascular Disease

Source: ClinicalTrials.gov · Last updated 20 Aug 2026

Brief summary (registry, in English)

The goal of this clinical trial is to determine if a machine learning/artificial intelligence (AI)-based electrocardiogram (ECG) algorithm (rECHOmmend and ECG-AF) can identify undiagnosed cardiovascular disease in patients. It will also examine the safety and effectiveness of using this AI-based tool in a clinical setting. The main questions it aims to answer are: 1. Can the AI-based ECG algorithm improve the detection of atrial fibrillation and structural heart disease? 2. How does the use of this algorithm affect clinical decision-making and patient outcomes? Researchers will compare the outcomes of healthcare providers who receive the AI-based ECG results to those who do not. Participants (healthcare providers) will: Be randomized into two groups: one that receives AI-based ECG results and one that does not. In the intervention group, receive an assessment of their patient's risk of atrial fibrillation or structural heart disease with each ordered ECG. Decide whether to perform further clinical evaluation based on the AI-generated risk assessment as part of routine clinical care.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
1000 (estimated)
First submitted
16 Jul 2024
Start date
16 Sept 2024
Primary completion date
Sept 2027
Lead sponsor
Northwestern University
NCT number
NCT06511505

What you commit to

  • Study type: Interventional
  • Planned participants: 1000
  • From 16 Sept 2024 to the primary completion date, Sept 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Who the study is looking for

  • 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

Age in the registry: 40 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Northwestern University
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.