AI-Enabled ECG Screening for Cardiovascular Disease
(NOTABLE Trial)

Recruiting in Palo Alto (17 mi)

Overseen bySanjiv Shah, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Northwestern University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Sanjiv Shah, MD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for healthcare providers who are assessing patients with potential cardiovascular issues like atrial fibrillation or structural heart disease. Providers will be randomly assigned to either use an AI-based ECG tool in their evaluations or not.

Inclusion Criteria

I am over 40 and have had an ECG as part of my regular health checks.

I am 65 or older and have had an ECG for my heart.

Exclusion Criteria

I have never had atrial fibrillation, don't have a pacemaker or ICD, and haven't had recent heart surgery.

I have no history of heart disease and haven't had a heart ultrasound in the last year.

Treatment Details

Interventions

TEMPUS AI-enabled ECG-based Screening Tool (Artificial Intelligence)

Trial OverviewThe NOTABLE Trial is testing whether a machine learning AI tool can help detect undiagnosed cardiovascular diseases more effectively when used alongside standard ECG tests in clinical settings.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Care teams randomized to the intervention will have access to the AI-enabled ECG-based screening tool.

Group II: ControlActive Control1 Intervention

Care teams randomized to control will continue routine practice without access to the AI-enabled ECG-based screening tool.