Emergency Stroke Unit for Acute Cerebrovascular Events ( ESU-ACE-B )

Mechanical thrombectomy is an effective reperfusion therapy for patients with acute ischemic stroke due to large vessel occlusion. Faster door-to-puncture time (DPT) 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-puncture time of patients with hyperacute ischemic stroke (between 4.5-6 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).

• The utility-weighted modified Rankin Scale (uw-mRS) at 14±2 days (or at discharge, whichever occurs first). [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: at 14±2 days (or at discharge, whichever occurs first).]
• The time from symptoms onset to endovascular thrombectomy decision. [Срок оценки: The time from symptoms onset to endovascular thrombectomy decision.]
• The time from emergency department arrival to endovascular thrombectomy decision. [Срок оценки: The time from emergency department arrival to endovascular thrombectomy decision.]
• Door-to-reperfusion time [Срок оценки: Door-to-reperfusion time]
• Symptomatic intracranial hemorrhages (according to the ECASS III criteria) within 36 hours. [Срок оценки: within 36 hours.]
• Symptomatic intracranial hemorrhages (according to the ECASS III criteria) at 14±2 days (or at discharge, whichever occurs first). [Срок оценки: at 14±2 days (or at discharge, whichever occurs first).]
• Mortality at 14±2 days (or at discharge, whichever occurs first). [Срок оценки: at 14±2 days (or at discharge, whichever occurs first).]
• Adverse events at 14±2 days (or at discharge, whichever occurs first). [Срок оценки: at 14±2 days (or at discharge, whichever occurs first).]
• Serious adverse events at 14±2 days (or at discharge, whichever occurs first). [Срок оценки: at 14±2 days (or at discharge, whichever occurs first).]