Emergency Stroke Unit for Acute Cerebrovascular Events--A Prospective, Multicenter, Week-wise Randomized, Controlled Trial ( ESU-ACE-C )
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,622
- 试验地点
- 1
- 主要终点
- The utility-weighted modified Rankin Scale (uw-mRS) at 90 days (± 7 days).
研究概览
简要总结
To compare the prognosis of patients with hyperacute ischemic stroke (who arrive at the emergency department within 4.5 hours of symptom onset) 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
The first MRI machines in the 1970s and 1980s were low-field due to technological limitations. As technology advanced, the focus shifted to higher field strengths to achieve better image resolution and faster scan times. Recently, there has been renewed interest in low-field MRI due to advancements in hardware and software, making them more viable for specific clinical applications, including acute stroke. Prompt and accurate imaging is crucial for diagnosing ischemic stroke and determining the appropriate treatment (e.g., thrombolysis or thrombectomy). Research has demonstrated that low-field MRI can effectively detect acute ischemic changes and distinguish between ischemic and hemorrhagic stroke. By providing accessible, cost-effective, and safe imaging, it can facilitate timely and accurate treatment, particularly in settings where high-field MRI is not readily available. This prospective, multicenter, week-wise randomized controlled trial will compare the prognosis of patients with hyperacute ischemic stroke (who arrive at the emergency department within 4.5 hours of symptom onset) 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;
- •Patients who arrive at the emergency department within 4.5 hours of symptom 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
The utility-weighted modified Rankin Scale (uw-mRS) at 90 days (± 7 days).
时间窗: at 90 days (± 7 days)
The utility-weighted modified Rankin Scale (uw-mRS) at 90 days (± 7 days). Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).
次要结局
- The time from symptoms onset to intravenous thrombolysis decision.(up to 4.5 hours from symptom onset)
- The time from emergency department arrival to intravenous thrombolysis decision.(up to 4.5 hours from symptom onset.)
- Ordinal (shift) analysis of modified Rankin Scale (mRS) at 90 days (± 7 days).(at 90 days (± 7 days))
- Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90 days (± 7 days).(at 90 days (± 7 days))
- Good functional outcome (Modified Rankin Scale score, mRS 0-2) at 90 days (± 7 days).(at 90 days (± 7 days))
- A 30% reduction (improvement) from baseline to 24 hours in the NIHSS score.(from baseline to 24 hours in the NIHSS score.)
- Proportion of participants ultimately treated with reperfusion therapy (separated rate of intravenous thrombolysis / endovascular thrombectomy / bridging therapy).(up to 6 hours from symptom onset.)
- The time from emergency department arrival to the start of intravenous thrombolysis.(up to 4.5 hours from symptom onset)
- The cost-effectiveness analysis.(up to 3 months from enrollment.)
- 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 90 days (± 7 days).(at 90 days (± 7 days).)
- Adverse events at 90 days (± 7 days).(at 90 days (± 7 days).)
- Serious adverse events at 90 days (± 7 days).(at 90 days (± 7 days).)
- Ordinal (shift) analysis of modified Rankin Scale (mRS) at 90 days (± 7 days).(at 90 days (± 7 days))
- Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90 days (± 7 days).(at 90 days (± 7 days))
- Good functional outcome (Modified Rankin Scale score, mRS 0-2) at 90 days (± 7 days).(at 90 days (± 7 days))
- A 30% reduction (improvement) from baseline to 24 hours in the NIHSS score.(from baseline to 24 hours in the NIHSS score.)
- The time from symptoms onset to intravenous thrombolysis decision.(up to 4.5 hours from symptom onset)
- The time from emergency department arrival to intravenous thrombolysis decision.(up to 4.5 hours from symptom onset.)
- Proportion of participants ultimately treated with reperfusion therapy (separated rate of intravenous thrombolysis / endovascular thrombectomy / bridging therapy).(up to 6 hours from symptom onset.)
- The time from emergency department arrival to the start of intravenous thrombolysis.(up to 4.5 hours from symptom onset)
- The cost-effectiveness analysis.(up to 3 months from enrollment.)
- 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 90 days (± 7 days).(at 90 days (± 7 days).)
- Mortality at 90 days (± 7 days).(at 90 days (± 7 days).)
- Adverse events at 90 days (± 7 days).(at 90 days (± 7 days).)
- Serious adverse events at 90 days (± 7 days).(at 90 days (± 7 days).)
研究者
Yongjun Wang
professor
Beijing Tiantan Hospital