Enhanced Detection of Underlying, Covert ATrial Fibrillation Using 7-day Holter Electrocardiogram in Patients With Embolic Stroke of Undetermined Source
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Detection of any atrial fibrillation
研究概览
简要总结
The aim of this study is to determine the diagnostic yield of continuous 7-day Holter ECG for detecting covert paroxysmal atrial fibrillation in patients with recent embolic stroke or transient ischemic attack (TIA) of undetermined cause after completion of a standard clinical work up including an initial 24-hour Holter monitoring.
详细描述
Covert atrial fibrillation (AF) is a relevant potential cause of a recently proposed clinical construct, "Embolic Stroke of Undetermined Source (ESUS)". However, routine post-stroke work up including 24-hour Holter monitoring may fail to detect paroxysmal AF. A recent systematic review has shown an increased AF detection rate with longer monitoring durations. The aim of this study is to evaluate the effectiveness of a novel ambulatory 7-day Holter ECG (EV-201, Parama-Tech inc.) for detecting AF in patients with recent ESUS after completion of a standard clinical examination.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Recent ESUS (within 3 months of onset) defined as:
- •A. Recent ischemic stroke (including transient ischemic attack with positive neuroimaging) visualized by brain imaging that is not lacunar B. Abscence of ≥ 50% stenosis or occlusion in cervical and intracranial arteries supplying ischemic area C. No atrial fibrillation after ≥ 24-hour Holter monitoring D. No intra-cardiac thrombus on transthoracic echocardiography E. No other major cardioembolic sources F. No other specific cause of stroke (for example, arteritis, dissection, migraine/vasospasm, drug abuse)
- •20 years of age or older
- •Signed written informed consent
排除标准
- •Previously documented atrial fibrillation
- •Untreated hyperthyroidism
- •Pacemaker or implantable cardioverter defibrillator implanted or planned to implant
- •Estimated life expectancy < 12 months
- •Examination of seven-day Holter ECG not applicable within 3 months after stroke onset.
- •Patients considered inappropriate to participate in the study
结局指标
主要结局
Detection of any atrial fibrillation
时间窗: After examination of 7-day Holter monitoring (within 90 days of stroke onset)
次要结局
- Change of antithrombotic drugs(After the examination of 7-day Holter monitoring)
- Any adverse event related to 7-day Holter monitoring(After the examination of 7-day Holter monitoring)
- Time to detection of atrial fibrillation on 7-day Holter monitoring(After the examination of 7-day Holter monitoring)
- Any ischemic or hemorrhagic event(365 days after index stroke)
- Atrial fibrillation burden(After the examination of 7-day Holter monitoring)
研究者
Yuichi Miyazaki
Principal Investigator
National Cerebral and Cardiovascular Center, Japan