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NOrthwestern Tempus AI-enaBLed Electrocardiography (NOTABLE) Trial

Northwestern University · with Tempus AI · NCT06511505

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 40+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
1000
US sites recruiting
1
Study start
September 16, 2024
Record last updated
August 20, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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:

  • Can the AI-based ECG algorithm improve the detection of atrial fibrillation and structural heart disease?
  • 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.

Being studied: Risk-Based Assessment for Cardiac Dysfunction

Conditions: Atrial Fibrillation; Cardiovascular Diseases; Arrhythmia; Valvular Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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 Criteria

  • 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

Recruiting US locations

  • Northwestern University

    Chicago, IL 60611

    Site contact: Sanjiv Shah, MD · 312-498-0894 · sanjiv.shah@northwestern.edu

All heart & blood pressure studies in Illinois →
NOrthwestern Tempus AI-enaBLed Electrocardiography (NOTABLE) Trial (NCT06511505) | Bored Studies