Impact of Standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,470
- 试验地点
- 1
- 主要终点
- Number of patients on oral anticoagulation (NOAC or VKA)
研究概览
简要总结
Investigator-initiated prospective randomized multicentre study to uncover the true burden of paroxysmal atrial fibrillation in a representative population of acute stroke patients without known atrial fibrillation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ischemic stroke or transitory ischemic attack (with clinical deficit on enrolment or MRI detected acute brain lesion on admission)
- •Age ≥ 18 years
- •Written or oral informed consent
- •Stroke unit admission within 72 hours after stroke onset
- •Start of standardized prolonged ECG monitoring within 24 hours after admission to the stroke unit
- •Willingness to take part in the planned follow up examinations
排除标准
- •Known atrial fibrillation
- •Atrial fibrillation detected by ECG on admission
- •Atrial fibrillation detected prior study enrollment on the stroke unit
- •Life expectancy < 1 year (before actual stroke)
- •Life expectancy < 1 month (after actual stroke)
- •Indication for oral anticoagulation other than atrial fibrillation (e.g. mechanical heart valve)
- •Severity level according National Institute of Health Stroke Scale (NIHSS) score > 22
- •Participation in an interventional trial
研究组 & 干预措施
prolonged ECG monitoring
Regular stroke unit treatment and diagnostic procedures according to guidelines and additional prolonged ECG monitoring
干预措施: prolonged ECG monitoring (Other)
prolonged ECG monitoring
Regular stroke unit treatment and diagnostic procedures according to guidelines and additional prolonged ECG monitoring
干预措施: ECG (Device)
no additional ECG recording
Regular stroke unit treatment and diagnostic procedures according to guidelines
结局指标
主要结局
Number of patients on oral anticoagulation (NOAC or VKA)
时间窗: 12 months
Number of study patients on oral anticoagulation (NOAC or VKA) at 12 months after the index stroke either randomized to standardized prolonged ECG monitoring in-hospital or those randomized to usual stroke unit diagnostic procedures alone.
次要结局
- Number of stroke patients with newly detected atrial fibrillation(7 days)
研究者
Matthias Endres
Prof. Dr. med.
Charite University, Berlin, Germany