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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
Sponsor:
Information provided by (Responsible Party):
Xiaoxi Yao, Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Asymptomatic Left Ventricular Systolic Dysfunction (Disorder) Heart Failure Other: AI-enabled ECG-based Screening Tool Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 358 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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

Arm Intervention/treatment
Experimental: Intervention
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.



Primary Outcome Measures :
  1. New Diagnosis of Low Ejection Fraction (defined as ejection fraction ≤50%) [ Time Frame: Within 90 days ]
    Ejection fraction obtained by echocardiography.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Xiaoxi Yao, PhD, MPH Mayo Clinic
Principal Investigator: Peter Noseworthy, MD Mayo Clinic
Additional Information:
Publications:
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Responsible Party: Xiaoxi Yao, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04000087    
Other Study ID Numbers: 19-003137
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Ventricular Dysfunction, Left
Heart Diseases
Cardiovascular Diseases
Ventricular Dysfunction