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

NCT05903313 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 4306

Last updated 2024-01-11

No results posted yet for this study

Summary

"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.

Conditions

  • 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
  • Myocardial Infarction

Interventions

DRUG

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.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-06
Primary Completion
2024-01-31
Completion
2024-02-28

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05903313 on ClinicalTrials.gov