Emergency Stroke Unit for Acute Cerebrovascular Events ( ESU-ACE-D )
NCT Number: NCT06522282
Status: NOT_YET_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
Sponsor: Beijing Tiantan Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-20
Completion Date: 2025-03-01

Summary:
To compare the prognosis 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).

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 endovascular thrombectomy decision., The time from symptoms onset to endovascular thrombectomy decision, assessed up to 6 hours from symptom onset., up to 6 hours from symptom onset|The time from emergency department arrival to endovascular thrombectomy decision., The time from emergency department arrival to endovascular thrombectomy decision, assessed up to 6 hours from symptom onset., up to 6 hours from symptom onset.|Proportion of participants ultimately treated with reperfusion 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 puncture of endovascular thrombectomy., The time from emergency department arrival to the puncture of endovascular thrombectomy (Door-to-puncture time \[DPT\]), assessed up to 6 hours from symptom onset., up to 6 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).