Emergency Stroke Unit for Acute Cerebrovascular Events ( ESU-ACE-C )
NCT Number: NCT06522269
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
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: 1622
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-08
Completion Date: 2025-07-01
Locations: Beijing Tiantan Hospital, Capital Medical University, Beijing, China

Summary:
To compare the prognosis 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: The utility-weighted modified Rankin Scale (uw-mRS) 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)., at 90 days (± 7 days)
Secondary Outcome Measures: Ordinal (shift) analysis of modified Rankin Scale (mRS) at 90 days (± 7 days)., Ordinal (shift) analysis of modified Rankin Scale (mRS) at 90 days (± 7 days). Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death)., at 90 days (± 7 days)|Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90 days (± 7 days)., Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90 days (± 7 days). Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death)., at 90 days (± 7 days)|Good functional outcome (Modified Rankin Scale score, mRS 0-2) at 90 days (± 7 days)., Good functional outcome (Modified Rankin Scale score, mRS 0-2) at 90 days (± 7 days). Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death)., at 90 days (± 7 days)|A 30% reduction (improvement) from baseline to 24 hours in the NIHSS score., A 30% reduction (improvement) from baseline to 24 hours in the NIHSS score. Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating greater neurological deficits., from baseline to 24 hours in the NIHSS score.|The time from symptoms onset to intravenous thrombolysis decision., The time from symptoms onset to intravenous thrombolysis decision, assessed up to 4.5 hours from symptom onset., up to 4.5 hours from symptom onset.|The time from emergency department arrival to intravenous thrombolysis decision., The time from emergency department arrival to intravenous thrombolysis decision, assessed up to 4.5 hours from symptom onset., 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)., Proportion of participants ultimately treated with reperfusion therapy (separated rate of intravenous thrombolysis / endovascular thrombectomy / bridging therapy), assessed up to 6 hours from symptom onset., up to 6 hours from symptom onset.|The time from emergency department arrival to the start of intravenous thrombolysis., The time from emergency department arrival to the start of intravenous thrombolysis, assessed up to 4.5 hours from symptom onset., up to 4.5 hours from symptom onset.|The cost-effectiveness analysis., Cost Effectiveness as measured by average patient QALYs, post-stroke healthcare utilization, incremental fixed costs associated with the ESU., up to 3 months from enrollment.|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 90 days (± 7 days)., Symptomatic intracranial hemorrhages at 90 days (± 7 days) (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 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).