Emergency Stroke Unit for Acute Cerebrovascular Events--A Prospective, Multicenter, Week-wise Randomized, Controlled Trial ( ESU-ACE-B )
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Ischemic Stroke, Acute
- Sponsor
- Yongjun Wang
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Door-to-puncture time
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
To compare the door-to-puncture time of patients with hyperacute ischemic stroke (between 4.5-6 hours after the onset of symptoms) treated in a standard stroke unit adherent to guidelines versus treated in Emergency Stroke Unit (a new stroke unit based on low-field magnetic resonance imaging).
Detailed Description
Mechanical thrombectomy is an effective reperfusion therapy for patients with acute ischemic stroke due to large vessel occlusion. Faster door-to-puncture time (DPT) 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-puncture time 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).
Investigators
Yongjun Wang
professor
Beijing Tiantan Hospital
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years;
- •Can be treated between 4.5-6 hours of symptoms onset\*(\*Symptom onset is defined by the "last seen normal" principle);
- •Presenting with ischemic stroke symptoms;
- •Pre-stroke mRS score 0-1;
- •Baseline NIHSS score ≥ 5;
- •Eligible for endovascular thrombectomy;
- •Informed consent signed.
Exclusion Criteria
- •Baseline NIHSS score \< 5;
- •Unable to undergo MRI because of claustrophobia;
- •Patients with cardiac pacemaker/brain pacemaker/insulin pump implantation;
- •Definite contraindication for endovascular thrombectomy;
- •Patients with postictal hemiparesis (Todd's paralysis) or those with concomitant neurological/psychiatric conditions who are unable or unwilling to cooperate;
- •Pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of trial;
- •Participation in other interventional randomized clinical trials within 3 months before enrollment;
- •Patients deemed unsuitable for participation in this trial by the investigator or those for whom participation in this trial may result in greater risks.
Outcomes
Primary Outcomes
Door-to-puncture time
Time Frame: Door-to-puncture time
The time from emergency department arrival to the puncture of endovascular thrombectomy.
Secondary Outcomes
- Ordinal (shift) analysis of modified Rankin Scale (mRS) at 14±2 days (or at discharge, whichever occurs first).(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).(at 14±2 days (or at discharge, whichever occurs first).)
- The time from symptoms onset to endovascular thrombectomy decision.(The time from symptoms onset to endovascular thrombectomy decision.)
- Symptomatic intracranial hemorrhages (according to the ECASS III criteria) within 36 hours.(within 36 hours.)
- Door-to-reperfusion time(Door-to-reperfusion time)
- Mortality at 14±2 days (or at discharge, whichever occurs first).(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).(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).(at 14±2 days (or at discharge, whichever occurs first).)
- The time from emergency department arrival to endovascular thrombectomy decision.(The time from emergency department arrival to endovascular thrombectomy decision.)
- Serious adverse events at 14±2 days (or at discharge, whichever occurs first).(at 14±2 days (or at discharge, whichever occurs first).)
- Symptomatic intracranial hemorrhages (according to the ECASS III criteria) 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).)