Clinical trial NCT06492239: Emergency Stroke Unit for Acute Cerebrovascular Events ( ESU-ACE-A )
Official title: Emergency Stroke Unit for Acute Cerebrovascular Events--A Prospective, Multicenter, Week-wise Randomized, Controlled Trial ( ESU-ACE-A )
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ischemic Stroke, Acute
Keywords: Emergency stroke unit
Low-field magnetic resonance imaging
Reperfusion therapy
Intravenous thrombolysis
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years;
2. Can be treated within 4.5 hours of symptoms onset\*(\*Symptom onset is defined by the "last seen normal" principle);
3. Presenting with ischemic stroke symptoms;
4. Pre-stroke mRS score 0-1;
5. Baseline NIHSS score ≥ 5;
6. Eligible for rt-PA/TNK thrombolysis;
7. Informed consent signed.

Exclusion Criteria:

1. Baseline NIHSS score \< 5;
2. Unable to undergo MRI because of claustrophobia;
3. Patients with cardiac pacemaker/brain pacemaker/insulin pump implantation;
4. Definite contraindication for rt-PA/TNK thrombolysis;
5. Patients with postictal hemiparesis (Todd's paralysis) or those with concomitant neurological/psychiatric conditions who are unable or unwilling to cooperate;
6. Pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of trial;
7. Participation in other interventional randomized clinical trials within 3 months before enrollment;
8. Patients deemed unsuitable for participation in this trial by the investigator or those for whom participation in this trial may result in greater risks.

Primary outcomes:
measure: Door-to-needle time
timeFrame: Door-to-needle time
Secondary outcomes:
measure: The utility-weighted modified Rankin Scale (uw-mRS) at 14±2 days (or at discharge, whichever occurs first).
timeFrame: at 14±2 days (or at discharge, whichever occurs first).
measure: Ordinal (shift) analysis of modified Rankin Scale (mRS) at 14±2 days (or at discharge, whichever occurs first).
timeFrame: at 14±2 days (or at discharge, whichever occurs first).
measure: Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 14±2 days (or at discharge, whichever occurs first).
timeFrame: at 14±2 days (or at discharge, whichever occurs first).
measure: Good functional outcome (Modified Rankin Scale score, mRS 0-2) at 14±2 days (or at discharge, whichever occurs first).
timeFrame: at 14±2 days (or at discharge, whichever occurs first).
measure: The utility-weighted modified Rankin Scale (uw-mRS) at 90±7 days.
timeFrame: at 90±7 days.
measure: Ordinal (shift) analysis of modified Rankin Scale (mRS) at 90±7 days.
timeFrame: at 90±7 days.
measure: Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90±7 days.
timeFrame: at 90±7 days.
measure: Good functional outcome (Modified Rankin Scale score, mRS 0-2) at 90±7 days
timeFrame: at 90±7 days.
measure: The time from symptoms onset to intravenous thrombolysis decision.
timeFrame: The time from symptoms onset to intravenous thrombolysis decision.
measure: The time from emergency department arrival to intravenous thrombolysis decision.
timeFrame: The time from emergency department arrival to intravenous thrombolysis decision.
measure: Symptomatic intracranial hemorrhages (according to the ECASS III criteria) within 36 hours.
timeFrame: within 36 hours.
measure: Symptomatic intracranial hemorrhages (according to the ECASS III criteria) at 14±2 days (or at discharge, whichever occurs first).
timeFrame: at 14±2 days (or at discharge, whichever occurs first).
measure: Mortality at 14±2 days (or at discharge, whichever occurs first).
timeFrame: at 14±2 days (or at discharge, whichever occurs first).
measure: Adverse events at 14±2 days (or at discharge, whichever occurs first).
timeFrame: at 14±2 days (or at discharge, whichever occurs first).
measure: Serious adverse events at 14±2 days (or at discharge, whichever occurs first).
timeFrame: at 14±2 days (or at discharge, whichever occurs first).
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Yongjun Wang
role: PRINCIPAL_INVESTIGATOR
References: