Prospective Validation Study of Artificial Intelligence-based Prediction Algorithm for the Prediction of Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 650
- 试验地点
- 11
- 主要终点
- Occurrence of paroxysmal AF
研究概览
简要总结
The purpose of this study is to predict the occurrence of paroxysmal atrial fibrillation by finding high-risk group from normal sinus rhythm ECG through artificial intelligence-based prediction algorithm.
详细描述
This study is a multi-center, prospective observational validation study. Patients aged 18 or above who are hospitalized at our hospital or who visited the outpatient clinic with arrhythmia symptoms (such as palpitation) after the clinical research approval will be enrolled. The normal sinus rhythm electrocardiogram (ECG) at the time of participation in the study is recorded and put into the artificial intelligence prediction algorithm. The result of risk stratification is blinded and will not be informed to both the research director and subjects. After applying wearable devices to the subject, the ECG recorded for the first week is analyzed to confirm the occurrence of paroxysmal atrial fibrillation (the gold standard for diagnosis of atrial fibrillation). When the wearable devices are removed, the 12 lead electrocardiogram will be taken again, and if it shows normal sinus rhythm electrocardiogram, then it will be put into the artificial intelligence prediction algorithm to calculate the result as well.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be above 20 in age
- •Participants are patients with symptom of arrhythmia who visited outpatient clinic or who have been hospitalized
排除标准
- •Excluding patients with cardiac implantable electronic device such as pacemakers, implantable defibrillators (ICD), or cardiac resynchronization therapy (CRT).
- •Excluding pregnant women and lactating women.
结局指标
主要结局
Occurrence of paroxysmal AF
时间窗: 1 week
The AI prediction algorithm classifies patients into high-risk and low-risk categories for predicting paroxysmal atrial fibrillation within a week, based on ECG recordings of those with normal sinus rhythm. The accuracy of the prediction will be assessed through the use of a wearable device that records occurrence of paroxysmal atrial fibrillation over the course of a week.
次要结局
- Performance verification of AI prediction model(1 week)