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

National Defense Medical Center, Taiwan

Status: Completed

Conditions: Left Ventricular Systolic Dysfunction (Disorder)

Treatments: Other: AI-enabled ECG-based Screening Tool

Study type: Interventional

Funder types: Other

Identifiers

NCT05117970

NDMC2021001

Details and patient eligibility

About

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.

Enrollment: 13,631 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13,631 participants in 2 patient groups

Intervention

Experimental group

Description:

Patients randomized to intervention will have access to the screening tool.

Treatment:

Other: AI-enabled ECG-based Screening Tool

Control

No Intervention group

Description:

Patients randomized to control will continue routine practice.