An observational study in Long QT Syndrome, Sinus Bradycardia and Sinus Tachycardia, sponsored by Chang Gung Memorial Hospital. Enrolling by invitation at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-01-11.
Sponsored by Chang Gung Memorial Hospital · Observational
"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
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 procedure:
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.
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.
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.
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).
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.
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.
101 studies on the registry are indexed under Long QT Syndrome; 20 are open to participants now.
This study's planned enrollment of 4,306 is above the median of 150 across 53 observational studies indexed under Long QT Syndrome.
Browse Long QT Syndrome studies →Chang Gung Memorial Hospital is the lead sponsor of 1,096 studies on the registry; 239 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Software diagnosis with gold standard of 3 cardiologists' interpretation.
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.
Also known as: CGMH-EAD-001
Sensitivity and Specificity
The rate of test results that correctly indicate the presence and absence.
Time frame: baseline
Area Under the receiver operating characteristic Curve
A graphical plot that illustrates the diagnostic ability of a binary classifier system as its discrimination threshold is varied.
Time frame: Baseline
Plan to share: No
Started Oct 2023 (actual). Primary completion is estimated for Jan 2024, 3 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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