ECG AI-Guided Screening for Low Ejection Fraction (EAGLE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04000087|
Recruitment Status : Active, not recruiting
First Posted : June 27, 2019
Last Update Posted : July 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Asymptomatic Left Ventricular Systolic Dysfunction (Disorder) Heart Failure||Other: AI-enabled ECG-based Screening Tool||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||358 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Electrocardiogram Artificial Intelligence-Guided Screening for Low Ejection Fraction (EAGLE)|
|Actual Study Start Date :||June 26, 2019|
|Actual Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||November 1, 2020|
Care teams randomized to intervention will have access to the screening tool.
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.
No Intervention: Control
Care teams randomized to control will continue routine practice.
- New Diagnosis of Low Ejection Fraction (defined as ejection fraction ≤50%) [ Time Frame: Within 90 days ]Ejection fraction obtained by echocardiography.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04000087
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Xiaoxi Yao, PhD, MPH||Mayo Clinic|
|Principal Investigator:||Peter Noseworthy, MD||Mayo Clinic|