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Completed

NCT Number: NCT05117970

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

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.

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Key information

Conditions

Left Ventricular Systolic Dysfunction (Disorder) Cardiovascular Diseases Heart Diseases Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Defense Medical Center

Taipei, 114, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

AI-enabled ECG-based Screening Tool

Other

Primary care clinicians in the intervention group had access to the report, which displayed whether the AI-ECG result was positive or negative.The system will send a message to corresponding physicians if positive finding.

Primary outcomes

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

    Time frame: Within 30 days

    Ejection fraction obtained by echocardiography

Secondary outcomes

  1. All cause mortality(death)

    Time frame: Within 30 days

    After performing an electrocardiogram, the patient's survival is tracked.

  2. Completion of an echocardiogram

    Time frame: Within 30 days

    After performing the ECG examination, perform the echocardiogram examination

Sponsors and collaborators

Lead sponsor

National Defense Medical Center, Taiwan

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 11, 2021
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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