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NOrthwestern Tempus AI-enaBLed Electrocardiography (NOTABLE) Trial

NCT06511505 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2024-07-22

No results posted yet for this study

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 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.

Conditions

Interventions

OTHER

TEMPUS AI-enabled ECG-based Screening Tool

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.

Sponsors & Collaborators

Principal Investigators

  • Sanjiv Shah, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-03
Primary Completion
2025-08-03
Completion
2026-02-03
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06511505 on ClinicalTrials.gov