Clinical trial NCT05903313: A Study to Evaluate Accuracy and Validity of the Chang Gung ECG Abnormality Detection Software
Official title: A Study to Evaluate Accuracy and Validity of the Chang Gung ECG Abnormality Detection Software
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 4306
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is a retrospective study, and the data comes from the Chang Gung Medical Research Database(CGRD) which was an database form 6 hospitals of Chang Gung Memorial hospital. According to inclusion and exclusion criteria, de-identified static 12-lead ECG data from the database during 2006.01.01\~2019.12.31 was collected, and the length of the ECG was 10 seconds.

Brief 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.

Detailed description: Detailed procedure:

1. Sample source:

   This is a retrospective study, and the data comes from the Chang Gung Medical Research Database(CGRD) which was an database form 6 hospitals of Chang Gung Memorial hospital. We collected de-identified static 12-lead ECG data from the database during 2006.01.01\~2019.12.31, and the length of the ECG was 10 seconds.
2. Sampling:

   In this experiment, the training dataset and the test dataset ECG were separated. Afterwards, the ECG signals are stratified according to the distribution as the test sample, and all abnormal ECG signals of 14 diseases will be independently sampled from the ECG database of the test set.
3. Confirmation criteria:

   The ECG data will be preliminarily screened and selected by the inclusion and exclusion criteria and compiled serial numbers. Then, a cardiologist confirms that the sampling results of the ECG data do not include the exclusion criteria again.
4. Physician interpretation:

   The ECG data will be converted into graphic files and submitted to 3 cardiologists for interpretation abnormal ECG signals of 14 related diseases. The results will be used as the standard of this study (Reference).
5. Software interpretation:

   After confirming the test standard, input the ECG signal into Chang Gung ECG Abnormality Detection Software to analyze abnormal ECG signals of 14 diseases and interpret each ECG data.
6. Statistical analysis:

After the software interpretation is completed, it will be compared with the results of the physician's interpretation and analyze the primary and secondary evaluation indicators.

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.

Primary outcomes:
measure: Sensitivity and Specificity
timeFrame: baseline
Secondary outcomes:
measure: Area Under the receiver operating characteristic Curve
timeFrame: Baseline
Other outcomes:
Locations:
city: Taoyuan city
country: Taiwan
facility: Chang Gung memorial hospital
Study officials:
affiliation: Associate Professor and Director Division of Rheumatology
name: Chang-Fu Kuo, MD/Ph.D
role: STUDY_CHAIR
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