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

Not Applicable

Completed

• Conditions: Left Ventricular Systolic Dysfunction (Disorder)
• Interventions: Other: AI-enabled ECG-based Screening Tool

• Registration Number: NCT05117970
• Lead Sponsor: National Defense Medical Center, Taiwan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-01
• Study First Submitted QC: 2021-11-01
• Study First Posted: 2021-11-11
• Study Start: 2021-12-09
• Primary Completion: 2023-05-31
• Study Completion: 2023-12-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13631

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	AI-enabled ECG-based Screening Tool	Patients randomized to intervention will have access to the screening tool.

Primary Outcome Measures

Name	Time	Method
New Diagnosis of Low Ejection Fraction(defined as ejection fraction ≤50%)	Within 30 days	Ejection fraction obtained by echocardiography

Secondary Outcome Measures

Name	Time	Method
All cause mortality(death)	Within 30 days	After performing an electrocardiogram, the patient's survival is tracked.
Completion of an echocardiogram	Within 30 days	After performing the ECG examination, perform the echocardiogram examination

Trial Locations

Locations (1)

National Defense Medical Center; 🇨🇳 Taipei, Taiwan