NCT06522282

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the prognosis of patients with hyperacute ischemic stroke (arriving at the emergency department between 4.5-6 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).

Detailed description

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 (arriving at the emergency department between 4.5-6 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).

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 (arriving at the emergency department between 4.5-6 hours of symptom onset) 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	The participants with hyperacute ischemic stroke (arriving at the emergency department between 4.5-6 hours of symptom onset) who are eligible to receive reperfusion therapy will be managed by standard stroke unit process adherent to guidelines.

Timeline

• Start date: 2024-08-10
• Primary completion: 2025-12-01
• Completion: 2026-03-01
• First posted: 2024-07-26
• Last updated: 2024-10-01

Locations

1 site across 1 country: China