A Study to Evaluate Accuracy and Validity of the Chang Gung Atrial Fibrillation Detecting Software
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 788
- 试验地点
- 2
- 主要终点
- Sensitivity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Cases used in the model development process.
- •Lacks any electrode.
- •Contain any electrode lacks a segment.
- •Misplaced leads
结局指标
主要结局
Sensitivity
时间窗: baseline
The rate of test results that correctly indicate the presence.
次要结局
- Accuracy(baseline)
- Positive predictive value(baseline)
- Specificity(baseline)
- Negative predictive value(baseline)
- False positive rate(baseline)
- Area Under the receiver operating characteristic Curve(baseline)
- False negative rate(baseline)