NCT01855035已完成不适用
A Prospective, Randomised, Controlled Study to Determine the Detection of Atrial Fibrillation by Prolonged and Enhanced Holter Monitoring as Compared to Usual Care in Stroke Patients
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH8 个研究点 分布在 1 个国家目标入组 402 人开始时间: 2013年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 402
- 试验地点
- 8
- 主要终点
- number of atrial fibrillation/flutter
研究概览
简要总结
The purpose of this study is to assess whether repeated enhanced and prolonged ECG monitoring after ischemic stroke results in a higher detection of atrial fibrillation (/flutter) compared to usual care (at least 24 hour of cardiac monitoring).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recent cerebral ischemia defined as stroke (sudden focal neurologic deficit lasting > 24h consistent with the territory of a major cerebral artery and categorised as ischemic) and/or a corresponding lesion on brain imaging.
- •Stroke symptoms started ≤ 7 days ago.
- •Age ≥ 60 years.
- •Modified Rankin scale ≤ 2 (prior to index event).
排除标准
- •Known history of atrial fibrillation/flutter or atrial fibrillation/flutter on admission ECG.
- •Indication for oral anticoagulation at randomisation.
- •Absolute contra-indication against oral anticoagulation at randomisation.
- •Intracerebral bleeding in medical history.
- •Patient scheduled for Holter-ECG or cardiac Event-Recording monitoring ≥ 48 hours.
- •Significant carotid artery or vertebral artery stenosis > 50% (NASCET classification), significant intracranial artery stenosis suspicious of atherosclerotic origin or acute arterial dissection explanatory of stroke symptoms.
- •Implanted pacemaker device or cardioverter/defibrillator.
- •Life expectancy < 1 year for reasons other than stroke (e.g. metastatic cancer).
- •Concomitant participation in other controlled randomised trial.
结局指标
主要结局
number of atrial fibrillation/flutter
时间窗: 30 month after study start
The primary endpoint is the detection of newly diagnosed atrial fibrillation/flutter within 6 months and before occurrence of recurrent stroke or systemic embolism in the treatment group compared to control group.
次要结局
- number of myocardial infarctions(24 months after study start)
- number of bleeding complications(24 months after study start)
- number of atrial fibrillation (/flutter) within 12 months after patient's inclusion(24 months after study start)
- number of cerebrovascular deaths(24 months after study start)
- quality of life(24 months after study start)
- number of atrial fibrillation (/flutter) without hospitalisation(30 months after study start)
- number of recurrent stroke or systemic embolism(24 months after study start)
- total mortality(24 months after study start)
- number of cardiovascular deaths(24 months after study start)
- number of transient ischemic attacks(24 months after study start)
- number of atrial fibrillation (/flutter) in extended monitoring period(24 months after study start)
- costs(24 months after study start)
- number of correct monitorings(24 months after study start)
研究者
研究点 (8)
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