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

NCT ID: NCT05117970

Last Updated: 2024-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13631 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-09

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Left Ventricular Systolic Dysfunction (Disorder)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

AI-enabled ECG-based Screening Tool

Intervention Type 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.

Control

Patients randomized to control will continue routine practice.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients with a history of heart failure or an EF\<= 35%.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Defense Medical Center, Taiwan

OTHER

Sponsor Role lead

Responsible Party

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Chin Lin

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Defense Medical Center

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Tsai DJ, Lin C, Liu WT, Lee CC, Chang CH, Lin WY, Liu YL, Chang DW, Hsieh PH, Tsai CS, Chen YH, Hung YJ, Lin CS. Artificial intelligence-assisted diagnosis and prognostication in low ejection fraction using electrocardiograms in inpatient department: a pragmatic randomized controlled trial. BMC Med. 2025 Jun 9;23(1):342. doi: 10.1186/s12916-025-04190-z.

Reference Type DERIVED
PMID: 40484925 (View on PubMed)

Other Identifiers

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NDMC2021001

Identifier Type: -

Identifier Source: org_study_id

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