Chang Gung memorial hospital
Taoyuan City, 333, Taiwan
NCT Number: NCT05872516
Chang Gung Atrial Fibrillation Detection Software is an artificial intelligence electrocardiogram signal analysis software that detects whether a patient has atrial fibrillation by static 12-lead ECG signals. This study is a non-inferiority test based on the control group. The main purpose is to verify whether Chang Gung atrial fibrillation detection software can correctly identify atrial fibrillation in patients with atrial fibrillation, and can be used to provide a reference for doctors to detect atrial fibrillation.
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Notify Me20 year–100 year
All sexes
Interventional
Not applicable
Taoyuan City, 333, Taiwan
This study is a retrospective study, and the data is from the six hospitals of Chang Gung Medical Research Database (CGRD). We collected de-identified static 12-lead electrocardiogram (ECG) data from the database during the period of January 1, 2006, to December 31, 2019.
We created a training set and a testing set of ECG data from the CGRD. Then, we stratified and sampled ECG signals from the testing set according to the actual proportion to obtain the experimental sample.
The computer first preliminarily screened and selected ECG data that met the inclusion and exclusion criteria, and then numbered them sequentially. A cardiologist confirmed that the sampled ECG data did not include exclusion criteria.
The ECG data were converted into images and interpreted for the presence or absence of atrial fibrillation by three cardiologists. Their results were used as the gold standard (reference) for this study.
After determining the experimental standards, the ECG signals were inputted into the Chang Gung Atrial Fibrillation Detection software for analysis and interpretation of each ECG data.
After the software interpretation was completed, the results were compared with the interpretations of the physicians, and the primary and secondary evaluation indicators were analyzed accordingly.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This software is expected to be used in clinical testing to interpret the static 12-lead ECG of adults who are over 20 years old and suspected of having atrial fibrillation, detect whether there is a signal of atrial fibrillation, and output the results for clinicians Near-instant auxiliary diagnostic use.
Time frame: baseline
The rate of test results that correctly indicate the presence.
Time frame: baseline
The rate of test results that correctly indicate the absence.
Time frame: baseline
The rate of all test results that correctly indicate.
Time frame: baseline
A graphical plot that illustrates the diagnostic ability of a binary classifier system as its discrimination threshold is varied.
Time frame: baseline
The proportions of positive results in statistics and diagnostic tests that are true positive results
Time frame: baseline
The proportions of negative results in statistics and diagnostic tests that are true negative results
Time frame: baseline
The rate of test result which wrongly indicates that a particular condition or attribute is present
Time frame: baseline
The rate of test result which wrongly indicates that a particular condition or attribute is absent
Chang Gung Memorial Hospital
Other
A Study to Evaluate Accuracy and Validity of the Chang Gung Atrial Fibrillation Detecting Software
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