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Clinical Trials/NCT05117970
NCT05117970
Completed
Not Applicable

Artificial Intelligence-assisted Diagnosis and Prognostication in Low Ejection Fraction Using Electrocardiograms

National Defense Medical Center, Taiwan1 site in 1 country13,631 target enrollmentDecember 9, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Left Ventricular Systolic Dysfunction (Disorder)
Sponsor
National Defense Medical Center, Taiwan
Enrollment
13631
Locations
1
Primary Endpoint
New Diagnosis of Low Ejection Fraction(defined as ejection fraction ≤50%)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 9, 2021
End Date
December 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National Defense Medical Center, Taiwan
Responsible Party
Principal Investigator
Principal Investigator

Chin Lin

Assistant Professor

National Defense Medical Center, Taiwan

Eligibility Criteria

Inclusion Criteria

  • Patients with EF\>50% or without Transesophageal Echocardiography (TEE)

Exclusion Criteria

  • Patients with a history of heart failure or an EF\<= 35%.

Outcomes

Primary Outcomes

New Diagnosis of Low Ejection Fraction(defined as ejection fraction ≤50%)

Time Frame: Within 30 days

Ejection fraction obtained by echocardiography

Secondary Outcomes

  • All cause mortality(death)(Within 30 days)
  • Completion of an echocardiogram(Within 30 days)

Study Sites (1)

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