Clinical Implication of Atrial Fibrillation Detection Using Wearable Device in Patients With Cryptogenic Stroke - The Comparison Between Short-term Continuous Patch and Long-term Discontinuous Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 337
- 试验地点
- 15
- 主要终点
- Atrial fibrillation detection rate
研究概览
简要总结
It is known that atrial fibrillation after stroke significantly increases the risk of stroke or systemic embolism. Accordingly, efforts have been made to detect hidden atrial fibrillation and apply treatment using anticoagulants instead of antiplatelet agents. The conventional method used to screen for atrial fibrillation in stroke patients who did not have atrial fibrillation at first admission is 24-hour Holter monitoring. This study will compare the detection rate of atrial fibrillation with discontinuous ECG monitoring three times a day and 72 hours of single-lead ECG patch monitoring compared with the conventional Holter test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed brain infarction
- •No history and diagnosis of atrial fibrillation at the time of admission
- •Rejected implantable loop recorder
- •Informed consent
排除标准
- •Cannot use KardiaMobile system alone or with the help of others
研究组 & 干预措施
Conventional Holter Monitoring Group
Holter monitoring is performed for 24 hours each at 1, 3, and 12 months after the diagnosis of stroke, and if atrial fibrillation is detected, the antiplatelet drug is changed to an anticoagulant.
干预措施: 24-hour Holter monitoring (Device)
Discontinuous Monitoring Group
Discontinuous ECG monitoring by finger contact is performed 3 times every day for 12 months after a stroke diagnosis. If atrial fibrillation is detected, the antiplatelet drug is changed to an anticoagulant.
干预措施: Discontinuous monitoring (Device)
Single-lead Continuous Patch Group
Continuous 72 hours of ECG monitoring by a single-lead patch is performed at a week and 1, 3, 6, 12 months after a stroke diagnosis. If atrial fibrillation is detected, the antiplatelet drug is changed to an anticoagulant.
干预措施: Continuous single-lead ECG Patch (Device)
结局指标
主要结局
Atrial fibrillation detection rate
时间窗: Until 1 year after stroke
Compare detection rates of each arms
次要结局
- Major adverse cardiac and cerebrovascular event(Until 1 year after stroke)
- Recurrent stroke(Until 1 year after stroke)
- Change from antiplatelet therapy to anticoagulants following AF detection(Until 1 year after stroke)
- Re-admission(Until 1 year after stroke)
- All-cause death(Until 1 year after stroke)