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

Primary Purpose

Left Ventricular Systolic Dysfunction (Disorder)

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
AI-enabled ECG-based Screening Tool
Sponsored by
National Defense Medical Center, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Left Ventricular Systolic Dysfunction (Disorder)

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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%.

Sites / Locations

  • National Defense Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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

Patients randomized to control will continue routine practice.

Outcomes

Primary Outcome Measures

New Diagnosis of Low Ejection Fraction(defined as ejection fraction ≤35%)
Ejection fraction obtained by echocardiography

Secondary Outcome Measures

All cause mortality(death)
After performing an electrocardiogram, the patient's survival is tracked.
Cardiovascular cause mortality(death)
After performing an electrocardiogram, the patient's survival is tracked.
Transesophageal Echocardiography (TEE)
After performing the ECG examination, perform theTransesophageal Echocardiography examination

Full Information

First Posted
November 1, 2021
Last Updated
February 3, 2023
Sponsor
National Defense Medical Center, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT05117970
Brief Title
Artificial Intelligence-assisted Diagnosis and Prognostication in Low Ejection Fraction Using Electrocardiograms
Official Title
Artificial Intelligence-assisted Diagnosis and Prognostication in Low Ejection Fraction Using Electrocardiograms
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Defense Medical Center, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Ventricular Systolic Dysfunction (Disorder)

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients randomized to intervention will have access to the screening tool.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients randomized to control will continue routine practice.
Intervention Type
Other
Intervention Name(s)
AI-enabled ECG-based Screening Tool
Intervention Description
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 Outcome Measure Information:
Title
New Diagnosis of Low Ejection Fraction(defined as ejection fraction ≤35%)
Description
Ejection fraction obtained by echocardiography
Time Frame
Within 90 days
Secondary Outcome Measure Information:
Title
All cause mortality(death)
Description
After performing an electrocardiogram, the patient's survival is tracked.
Time Frame
Within 365 days
Title
Cardiovascular cause mortality(death)
Description
After performing an electrocardiogram, the patient's survival is tracked.
Time Frame
Within 365 days
Title
Transesophageal Echocardiography (TEE)
Description
After performing the ECG examination, perform theTransesophageal Echocardiography examination
Time Frame
Within 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with EF>50% or without Transesophageal Echocardiography (TEE) Exclusion Criteria: Patients with a history of heart failure or an EF<= 35%.
Facility Information:
Facility Name
National Defense Medical Center
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tai-Lung Cha
Phone
+886287923100
Email
director@mail.ndmctsgh.edu.tw
First Name & Middle Initial & Last Name & Degree
Ching-Liang Ho
Phone
+886287923100
Email
director@mail.ndmctsgh.edu.tw
First Name & Middle Initial & Last Name & Degree
Chin Lin, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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