An interventional study of Chang Gung Atrial Fibrillation Detecting Software in Atrial Fibrillation, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-05-24.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Diagnostic
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.
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 788 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Software diagnosis with gold standard of 3 doctors' consensus.
Device: Chang Gung Atrial Fibrillation Detecting Software
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.
Sensitivity
The rate of test results that correctly indicate the presence.
Time frame: baseline
Specificity
The rate of test results that correctly indicate the absence.
Time frame: baseline
Accuracy
The rate of all test results that correctly indicate.
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
Positive predictive value
The proportions of positive results in statistics and diagnostic tests that are true positive results
Time frame: baseline
Negative predictive value
The proportions of negative results in statistics and diagnostic tests that are true negative results
Time frame: baseline
False positive rate
The rate of test result which wrongly indicates that a particular condition or attribute is present
Time frame: baseline
False negative rate
The rate of test result which wrongly indicates that a particular condition or attribute is absent
Time frame: baseline
Plan to share: No
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital