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临床试验/NCT02578979
NCT02578979已完成不适用

Serial Electrocardiogram Versus Holter to Detect Atrial Fibrillation in Elderly Patients With Acute Ischemic Stroke: Study Protocol of a Randomized Controlled Trial

Chang Gung Memorial Hospital12 个研究点 分布在 1 个国家目标入组 826 人开始时间: 2015年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
826
试验地点
12
主要终点
Number of atrial fibrillation detected

研究概览

简要总结

Paroxysmal atrial fibrillation is often undetected because characteristics such as short duration, episodic, and frequently asymptomatic nature make it challenging to diagnose at the bedside, leading to suboptimal secondary prevention. It is not uncommon for paroxysmal atrial fibrillation to be undetected in a single electrocardiogram (ECG) on admission. Conventional 24-hour Holter monitoring is often used to detect paroxysmal atrial fibrillation. However, systematic review suggests Holter monitoring will identify atrial fibrillation in only an additional 4.6% of patients, no better than detection rates observed in groups lacking routine monitoring. On the other hand, for ischemic stroke patients with sinus rhythm at baseline but paroxysmal atrial fibrillation still suspected, no recommendation beyond repeated 12-lead ECGs is made in the United Kingdom guideline. Serial 12-lead ECG has been used to detect possible paroxysmal atrial fibrillation among acute ischemic stroke patients and found 15 new cases of atrial fibrillation in 133 acute ischemic stroke patients (11.3%) without atrial fibrillation at baseline. The optimal investigation strategy, including modality, duration of investigation, and patient subgroup remains undefined, not only for efficacy in the detection of atrial fibrillation, but also cost-effectiveness in healthcare systems. The objective of this project is to conduct a pragmatic multicenter randomized controlled trial for the comparison of serial 12-lead ECG once daily for 5 days and 24-hour Holter to detect paroxysmal atrial fibrillation in acute ischemic stroke patients without atrial fibrillation identified by baseline ECG or history.

详细描述

Investigators plan to enroll 900 participants from six hospitals in Taiwan. Patients will be eligible for enrollment if they are admitted due to acute ischemic stroke within 2 days, with 65 years of age or older, do not have known atrial fibrillation on history or baseline ECG at admission. Investigators will randomly assigned participants in a 1:1 ratio to undergo daily 12-lead ECG once daily for 5 days (intervention group) or 24-hour Holter monitoring (control group).

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cerebral ischemia defined as stroke (sudden focal neurologic deficit lasting >24 h consistent with the territory of a major cerebral artery and categorized as ischemic) and/or a corresponding lesion on brain imaging
  • Stroke symptoms within 2 days
  • Age ≥65 years

排除标准

  • History of atrial fibrillation or documented atrial fibrillation prior to randomization
  • Indication for oral anticoagulation at randomization
  • Absolute contraindication for oral anticoagulation at randomization
  • Intracerebral hemorrhage in medical history
  • Implanted pacemaker device or cardioverter/defibrillator
  • End stage renal disease

研究组 & 干预措施

ECG for 5 days

Experimental

Patients will receive 12-lead electrocardiogram for 5 days during their hospitalization.

干预措施: Electrocardiogram (Device)

24-h Holter

Active Comparator

Patients will receive a 24-h Holter during their hospitalization.

干预措施: Holter (Device)

结局指标

主要结局

Number of atrial fibrillation detected

时间窗: within 3 month of stroke onset

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Meng Lee

Associate Professor

Chang Gung Memorial Hospital

研究点 (12)

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