Clinical trial

A Study to Evaluate Accuracy and Validity of the Chang Gung ECG Abnormality Detection Software

Name

202300710A5

Description

"Chang Gung ECG Abnormality Detection Software" is a is an artificial intelligence medical signal analysis software that detect whether patients have abnormal ECG signals of 14 diseases by static 12-lead ECG. The 14 diseases were * Long QT syndrome * Sinus bradycardia * Sinus Tachycardia * Premature atrial complexes * Premature ventricular complexes * Atrial Flutter, Right bundle branch block * Left bundle branch block * Left Ventricular hypertrophy * Anterior wall Myocardial Infarction * Septal wall Myocardial Infarction * Lateral wall Myocardial Infarction * Inferior wall Myocardial Infarction * Posterior wall Myocardial Infarction The main purpose of this study is to verify whether "Chang Gung ECG Abnormality Detection Software" can correctly identify abnormal ECG signals among patients of 14 diseases. The interpretation standard is the consensus of 3 cardiologists. The results of the software analysis will be used to evaluate the performance of the primary and secondary evaluation indicators.

Trial arms

Trial start

2023-10-06

Estimated PCD

2024-01-31

Trial end

2024-02-28

Treatment

Chang Gung ECG Abnormality Detection Software

This device is expected to be used for the static 12-lead ECG to detect whether there are abnormal ECG signals related to diseases and outputs the results.

Arms:

Software diagnosis

Other names:

CGMH-EAD-001

Size

4306

Primary endpoint

Sensitivity and Specificity

baseline

Eligibility criteria

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). * The electrocardiogram signal is 500 Hz. * The Alternating current (AC) filter of the electrocardiogram signal is 60 Hz. * The resource of original diagnosis was a cardiologist. Exclusion Criteria: * Cases used in the model development process. * Lacks any electrode. * Contain any electrode lacks a segment.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 4306, 'type': 'ESTIMATED'}}

Updated at

2024-01-11

1 organization

1 product

10 indications

Organization

Chang Gung Memorial Hospital

Product

Chang Gung ECG Abnormality Detection Software

Indication

Long QT syndrome

Indication