NOrthwestern Tempus AI-enaBLed Electrocardiography (NOTABLE) Trial

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT06511505
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TEMPUS AI-enabled ECG-based Screening Tool — OTHER
    The AI-enabled ECG-based screening tool, Tempus Next software, analyzes 12-lead ECG recordings to identify patients at increased risk for undiagnosed cardiovascular diseases, specifically atrial fibrillation (AF) and structural heart disease (SHD). Clinicians in the intervention group will receive a risk assessment for AF and SHD each time they order an ECG for their patients.

Study Details

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 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.

Key Dates

Start date
Aug 3, 2024
Status verified
Jul 2024
Primary completion
Aug 3, 2025
Completion
Feb 3, 2026

Study Design

Enrollment
1,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: Intervention
    Care teams randomized to the intervention will have access to the AI-enabled ECG-based screening tool.
  • No Intervention: Control
    Care teams randomized to control will continue routine practice without access to the AI-enabled ECG-based screening tool.

Primary Outcome Measure

Rate of new CV diagnoses at 6 months [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Sanjiv Shah, MD
[email protected]

Find similar trials in Chicago, IL

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
Northwestern University· Chicago, IL

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