Atrial Fibrillation Detecting Software Gung Atrial Fibrillation Detecting Software
- Conditions
- Atrial Fibrillation
- Interventions
- Device: Chang Gung Atrial Fibrillation Detecting Software
- Registration Number
- NCT05872516
- Lead Sponsor
- Chang Gung Memorial Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 788
- 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.
- Cases used in the model development process.
- Lacks any electrode.
- Contain any electrode lacks a segment.
- Misplaced leads
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Software diagnosis Chang Gung Atrial Fibrillation Detecting Software Software diagnosis with gold standard of 3 doctors' consensus.
- Primary Outcome Measures
Name Time Method Sensitivity baseline The rate of test results that correctly indicate the presence.
- Secondary Outcome Measures
Name Time Method Accuracy baseline The rate of all test results that correctly indicate.
Positive predictive value baseline The proportions of positive results in statistics and diagnostic tests that are true positive results
Specificity baseline The rate of test results that correctly indicate the absence.
Negative predictive value baseline The proportions of negative results in statistics and diagnostic tests that are true negative results
False positive rate baseline The rate of test result which wrongly indicates that a particular condition or attribute is present
Area Under the receiver operating characteristic Curve baseline A graphical plot that illustrates the diagnostic ability of a binary classifier system as its discrimination threshold is varied.
False negative rate baseline The rate of test result which wrongly indicates that a particular condition or attribute is absent
Trial Locations
- Locations (1)
Chang Gung memorial hospital
🇨🇳Taoyuan City, Taiwan