Emergency Stroke Unit for Acute Cerebrovascular Events ( ESU-ACE-B )
- Conditions
- Ischemic Stroke, Acute
- Interventions
- Combination Product: Standard stroke unit adherent to guidelinesCombination Product: Emergency Stroke Unit based on 0.23-T MRI
- Registration Number
- NCT06492265
- Lead Sponsor
- Yongjun Wang
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard stroke unit adherent to guidelines Standard stroke unit adherent to guidelines The participants with hyperacute ischemic stroke (between 4.5-6 hours after onset of symptoms) who are eligible to receive reperfusion therapy will be managed by standard stroke unit process adherent to guidelines. Emergency Stroke Unit based on 0.23-T MRI Emergency Stroke Unit based on 0.23-T MRI The participants with hyperacute ischemic stroke (between 4.5-6 hours after onset of symptoms) who are eligible to receive reperfusion therapy will be managed by Emergency Stroke Unit process based on low-field magnetic resonance imaging.
- Primary Outcome Measures
Name Time Method Door-to-puncture time Door-to-puncture time The time from emergency department arrival to the puncture of endovascular thrombectomy.
- Secondary Outcome Measures
Name Time Method 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). 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).
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). 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).
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. 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).
Door-to-reperfusion time Door-to-reperfusion time The interval between emergency department arrival and the vascular recanalization.
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). 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).
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). 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).
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). 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).
Adverse events at 14±2 days (or at discharge, whichever occurs first). at 14±2 days (or at discharge, whichever occurs first).
Trial Locations
- Locations (1)
Beijing Tiantan Hospital, Capital Medical University
🇨🇳Beijing, China