Emergency Stroke Unit for Acute Cerebrovascular Events ( ESU-ACE-A )
NCT Number: NCT06492239
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Ischemic Stroke, Acute
Interventions: COMBINATION_PRODUCT: Emergency Stroke Unit based on 0.23-T MRI|COMBINATION_PRODUCT: Standard stroke unit adherent to guidelines
Sponsor: Beijing Tiantan Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-26
Completion Date: 2025-08-01
Locations: Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing, 100070, China

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).

Primary Outcome Measures: Door-to-needle time, The time from emergency department arrival to the start of intravenous thrombolysis., Door-to-needle time
Secondary Outcome Measures: The utility-weighted modified Rankin Scale (uw-mRS) at 14±2 days (or at discharge, whichever occurs first)., The utility-weighted modified Rankin Scale (uw-mRS) at 14±2 days (or at discharge, whichever occurs first). Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death)., 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)., Ordinal (shift) analysis of modified Rankin Scale (mRS) at 14±2 days (or at discharge, whichever occurs first). Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death)., 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)., Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 14±2 days (or at discharge, whichever occurs first). Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death)., 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)., Good functional outcome (Modified Rankin Scale score, mRS 0-2) at 14±2 days (or at discharge, whichever occurs first). Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death)., at 14±2 days (or at discharge, whichever occurs first).|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., Symptomatic intracranial hemorrhages within 36 hours (sICH definition: according to the ECASS III criteria: any apparently extravascular blood in the brain or within the cranium that was associated with clinical deterioration, as defined by an increase of 4 points or more in the score on the NIHSS, or that led to death and that was identified as the predominant cause of the neurological deterioration)., within 36 hours.|Symptomatic intracranial hemorrhages (according to the ECASS III criteria) at 14±2 days (or at discharge, whichever occurs first)., Symptomatic intracranial hemorrhages at 14±2 days (or at discharge, whichever occurs first) (sICH definition: according to the ECASS III criteria: any apparently extravascular blood in the brain or within the cranium that was associated with clinical deterioration, as defined by an increase of 4 points or more in the score on the NIHSS, or that led to death and that was identified as the predominant cause of the neurological deterioration)., 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).