NCT06492239

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

Emergency Stroke Unit for Acute Cerebrovascular Events--A Prospective, Multicenter, Week-wise Randomized, Controlled Trial ( ESU-ACE-A )

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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).

Conditions

• Ischemic Stroke, Acute

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Emergency Stroke Unit based on 0.23-T MRI	The participants with hyperacute ischemic stroke (symptoms onset ≤4.5 h) who are eligible to receive reperfusion therapy will be managed by Emergency Stroke Unit process based on low-field magnetic resonance imaging.
COMBINATION_PRODUCT	Standard stroke unit adherent to guidelines	The participants with hyperacute ischemic stroke (symptoms onset ≤4.5 h) who are eligible to receive reperfusion therapy will be managed by standard stroke unit process adherent to guidelines.

Timeline

• Start date: 2024-07-26
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2024-07-09
• Last updated: 2025-03-04

Locations

1 site across 1 country: China