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

February 3, 2023 updated by: Chin Lin, National Defense Medical Center, Taiwan
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

84000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 114
        • Recruiting
        • National Defense Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
Patients randomized to intervention will have access to the screening tool.
Other: AI-enabled ECG-based Screening Tool
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.
NO_INTERVENTION: Control
Patients randomized to control will continue routine practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New Diagnosis of Low Ejection Fraction(defined as ejection fraction ≤35%)
Time Frame: Within 90 days
Ejection fraction obtained by echocardiography
Within 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality(death)
Time Frame: Within 365 days
After performing an electrocardiogram, the patient's survival is tracked.
Within 365 days
Cardiovascular cause mortality(death)
Time Frame: Within 365 days
After performing an electrocardiogram, the patient's survival is tracked.
Within 365 days
Transesophageal Echocardiography (TEE)
Time Frame: Within 90 days
After performing the ECG examination, perform theTransesophageal Echocardiography examination
Within 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Defense Medical Center, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 9, 2021

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2024

Study Registration Dates

First Submitted

November 1, 2021

First Submitted That Met QC Criteria

November 1, 2021

First Posted (ACTUAL)

November 11, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 3, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NDMC2021001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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