ECG AI-Guided Screening for Low Ejection Fraction

Heart Failure Clinical Trial

— EAGLE  

Official title:

Electrocardiogram Artificial Intelligence-Guided Screening for Low Ejection Fraction (EAGLE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04000087
• Other study ID #: 19-003137
• Status: Completed
• Phase: N/A
• Start date: June 26, 2019
• Est. completion date: November 1, 2020

Study information

• Verified date: May 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized controlled trial (RCT) to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis and management of left ventricular systolic dysfunction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 358
• Est. completion date: November 1, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary care clinicians who are part of a participating care team that care for adult patients and have the ability to order ECG and TTE (this includes physicians, nurse practitioners, and physician assistants).

Exclusion Criteria:

• Primary care clinicians working in pediatrics, acute care, nursing homes, and resident care teams.

Related Conditions & MeSH terms

• Asymptomatic Left Ventricular Systolic Dysfunction (Disorder)
• Heart Failure
• Ventricular Dysfunction, Left

Intervention

Other:
• AI-enabled ECG-based Screening Tool
A novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis and management of left ventricular systolic dysfunction.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Yao X, McCoy RG, Friedman PA, Shah ND, Barry BA, Behnken EM, Inselman JW, Attia ZI, Noseworthy PA. ECG AI-Guided Screening for Low Ejection Fraction (EAGLE): Rationale and design of a pragmatic cluster randomized trial. Am Heart J. 2020 Jan;219:31-36. doi: 10.1016/j.ahj.2019.10.007. Epub 2019 Oct 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New Diagnosis of Low Ejection Fraction (defined as ejection fraction =50%)	Ejection fraction obtained by echocardiography.	Within 90 days

External Links

•   Mayo Clinic Clinical Trials