A Study to Evaluate Accuracy and Validity of the "Chang Gung" Ventricular Systolic Dysfunction Screening Software

October 11, 2023 updated by: Chang Gung Memorial Hospital

The purpose of this research is to test a software tool called the "Chang Gung" Ventricular Systolic Dysfunction screening software, which uses a 12-lead electrocardiogram to determine if a patient has left ventricular systolic dysfunction. The goal is to determine if the software can accurately identify patients with this condition, which would help doctors diagnose and treat it more effectively.

The trial will involve using the software on patients and comparing its results to those obtained through echocardiograms, which are currently the gold standard for diagnosing left ventricular systolic dysfunction. Only patients who meet specific eligibility criteria will be able to participate in the trial, and the software will be administered by trained healthcare professionals.

The study will help determine if the software is a useful tool for diagnosing left ventricular systolic dysfunction, which could lead to earlier diagnosis and better outcomes for patients. The research team will collect and analyze data on the accuracy of the software and its usability in clinical practice.

Overall, this study will provide important information for doctors and patients about a new tool for diagnosing left ventricular systolic dysfunction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a retrospective study conducted in Taiwan that aimed to test the performance of "Chang Gung" Ventricular Systolic Dysfunction screening software using electrocardiogram (ECG) and echocardiography data. The study data was obtained from a database that includes six hospitals of Chang Gung Memorial Hospital, between January 1, 2006, and December 31, 2019.

The software was developed using a training set of 133,225 data and validated using a set of 57,134 data. For clinical validation, a total of 1,172 test data were randomly selected from the testing set, stratified by hospital classification, age group and gender. The hospital classification, age group and gender ratios were based on the proportion of the testing data. The test data were also stratified by the presence or absence of left ventricular systolic dysfunction(LVSD) for test group and control group, defined as a heart output rate of less than 40% within 14 days before and after the ECG recording.

During the clinical trial, a cardiologist with 15 years of experience in treating cardiovascular disease examined the ECG data without any exclusion criteria. The cardiologist also confirmed the accuracy of the left ventricular ejection fraction (LVEF) measurement, which was defined as LVSD in the echocardiography reports. The LVEF was extracted from legally-binding echocardiography reports, not by the cardiologist during the clinical trial. The ECG data were screened and filtered for quality before being input into the software. The primary outcome was the sensitivity of the software, which was defined as not inferior to 0.86. The study also analyzed secondary outcome measures, including the area under the receiver operating characteristic curve, accuracy, specificity, positive predictive value, negative predictive value, false-positive rate, and false-negative rate.

Study Type

Interventional

Enrollment (Actual)

1172

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 Contact

  • Name: Chang-Fu Kuo, MD/Ph.D
  • Phone Number: 7731 +886 033281200
  • Email: zandis@gmail.com

Study Locations

  • Taiwan
      • Taoyuan City, Taiwan, 333
        • Chang Gung Memorial Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Equal or greater than twenty years old.
  • Static 12-lead electrocardiogram of General Electric MUSE XML format file.
  • The data comes from the static 12-lead electrocardiogram device of General Electric (model MAC5500).
  • Echocardiography data within 14 days before or after the electrocardiogram acquisition time.
  • The electrocardiogram signal is 500 Hz.
  • The Alternating current (AC) filter of the electrocardiogram signal is 60 Hz.
  • The length of the electrocardiogram signal is ten seconds (the electrocardiogram output of model MAC5500 is ten seconds, and there is no need to capture a segment).

Exclusion Criteria:

  • Cases used in the model development process.
  • Lacks any electrode.
  • Contain any electrode lacks a segment.

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Software diagnosis
Software diagnosis with gold standard of echocardiography.
Device: "Chang Gung" Ventricular Systolic Dysfunction Screening Software
This software is suitable for 12-lead ECG signals of adults over 20 years old, and assists doctors in screening patients for left ventricular systolic dysfunction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: baseline
The rate of test results that correctly indicate the presence.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity
Time Frame: Baseline
The rate of test results that correctly indicate the absence.
Baseline
Accuracy
Time Frame: Baseline
The rate of all test results that correctly indicated.
Baseline
Area Under the receiver operating characteristic Curve
Time Frame: Baseline
A graphical plot that illustrates the diagnostic ability of a binary classifier system as its discrimination threshold is varied.
Baseline
Positive predictive value
Time Frame: Baseline
The proportions of positive results in statistics and diagnostic tests that are true positive results
Baseline
Negative predictive value
Time Frame: Baseline
The proportions of negative results in statistics and diagnostic tests that are true negative results
Baseline
False positive rate
Time Frame: Baseline
The rate of test result which wrongly indicates that a particular condition or attribute is present
Baseline
False negative rate
Time Frame: Baseline
The rate of test result which wrongly indicates that a particular condition or attribute is absent
Baseline

Collaborators and Investigators

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

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Study Chair: Chang-Fu Kuo, MD/Ph.D, Associate Professor and Director Division of Rheumatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 15, 2023

Primary Completion (Actual)

August 15, 2023

Study Completion (Actual)

October 2, 2023

Study Registration Dates

First Submitted

May 2, 2023

First Submitted That Met QC Criteria

May 14, 2023

First Posted (Actual)

May 16, 2023

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202200402B0C602

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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