Emergency Stroke Unit for Acute Cerebrovascular Events--A Prospective, Multicenter, Week-wise Randomized, Controlled Trial ( ESU-ACE-A )
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- Door-to-needle time
研究概览
简要总结
To compare the door-to-needle time of patients with hyperacute ischemic stroke (within 4.5 hours after the onset of symptoms) managed in a standard stroke unit adherent to guidelines versus managed in Emergency Stroke Unit (a new stroke unit based on low-field magnetic resonance imaging).
详细描述
Intravenous thrombolysis is an effective reperfusion therapy for patients with acute ischemic stroke. Faster door-to-needle time (DNT) is associated with significantly better clinical outcomes. With the development of low-field magnetic resonance imaging, it is poised to play an increasingly significant role in the early diagnosis and management of acute ischemic stroke. This prospective, multicenter, week-wise randomized controlled trial will compare the door-to-needle time of patients with hyperacute ischemic stroke (within 4.5 hours after the onset of symptoms) managed in a standard stroke unit adherent to guidelines versus managed in Emergency Stroke Unit (a new stroke unit based on low-field magnetic resonance imaging).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Age ≥ 18 years;
- •Can be treated within 4.5 hours of symptoms onset*(*Symptom onset is defined by the "last seen normal" principle);
- •Presenting with ischemic stroke symptoms;
- •Pre-stroke mRS score 0-1;
- •Baseline NIHSS score ≥ 5;
- •Eligible for rt-PA/TNK thrombolysis;
- •Informed consent signed.
排除标准
- •Baseline NIHSS score < 5;
- •Unable to undergo MRI because of claustrophobia;
- •Patients with cardiac pacemaker/brain pacemaker/insulin pump implantation;
- •Definite contraindication for rt-PA/TNK thrombolysis;
- •Patients with postictal hemiparesis (Todd's paralysis) or those with concomitant neurological/psychiatric conditions who are unable or unwilling to cooperate;
- •Pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of trial;
- •Participation in other interventional randomized clinical trials within 3 months before enrollment;
- •Patients deemed unsuitable for participation in this trial by the investigator or those for whom participation in this trial may result in greater risks.
结局指标
主要结局
Door-to-needle time
时间窗: Door-to-needle time
The time from emergency department arrival to the start of intravenous thrombolysis.
次要结局
- The utility-weighted modified Rankin Scale (uw-mRS) at 14±2 days (or at discharge, whichever occurs first).(at 14±2 days (or at discharge, whichever occurs first).)
- Ordinal (shift) analysis of modified Rankin Scale (mRS) at 14±2 days (or at discharge, whichever occurs first).(at 14±2 days (or at discharge, whichever occurs first).)
- Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 14±2 days (or at discharge, whichever occurs first).(at 14±2 days (or at discharge, whichever occurs first).)
- Good functional outcome (Modified Rankin Scale score, mRS 0-2) at 14±2 days (or at discharge, whichever occurs first).(at 14±2 days (or at discharge, whichever occurs first).)
- The utility-weighted modified Rankin Scale (uw-mRS) at 90±7 days.(at 90±7 days.)
- Ordinal (shift) analysis of modified Rankin Scale (mRS) at 90±7 days.(at 90±7 days.)
- Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90±7 days.(at 90±7 days.)
- Good functional outcome (Modified Rankin Scale score, mRS 0-2) at 90±7 days(at 90±7 days.)
- The time from symptoms onset to intravenous thrombolysis decision.(The time from symptoms onset to intravenous thrombolysis decision.)
- The time from emergency department arrival to intravenous thrombolysis decision.(The time from emergency department arrival to intravenous thrombolysis decision.)
- Symptomatic intracranial hemorrhages (according to the ECASS III criteria) within 36 hours.(within 36 hours.)
- Symptomatic intracranial hemorrhages (according to the ECASS III criteria) at 14±2 days (or at discharge, whichever occurs first).(at 14±2 days (or at discharge, whichever occurs first).)
- Mortality at 14±2 days (or at discharge, whichever occurs first).(at 14±2 days (or at discharge, whichever occurs first).)
- Adverse events at 14±2 days (or at discharge, whichever occurs first).(at 14±2 days (or at discharge, whichever occurs first).)
- Serious adverse events at 14±2 days (or at discharge, whichever occurs first).(at 14±2 days (or at discharge, whichever occurs first).)
研究者
Yongjun Wang
professor
Beijing Tiantan Hospital