Emergency Stroke Unit for treating acute ischemic stroke

Emergency Stroke Unit for Acute Cerebrovascular Events--A Prospective, Multicenter, Week-wise Randomized, Controlled Trial ( ESU-ACE-B )

This study is testing if treating patients with a recent stroke in a special Emergency Stroke Unit can help them get faster care compared to a regular stroke unit.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Tiantan Hospital (other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06492265 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the door-to-puncture time of patients with hyperacute ischemic stroke treated in a standard stroke unit versus those treated in a newly developed Emergency Stroke Unit utilizing low-field magnetic resonance imaging. The study focuses on patients presenting with ischemic stroke symptoms between 4.5 to 6 hours after symptom onset. By employing a multicenter, week-wise randomized controlled trial design, the research seeks to determine if the Emergency Stroke Unit can improve timely access to reperfusion therapy, which is critical for better clinical outcomes. The trial will assess the effectiveness of this innovative approach in managing acute cerebrovascular events.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who present with ischemic stroke symptoms and can be treated within 4.5 to 6 hours of symptom onset.

Not a fit: Patients with a baseline NIHSS score below 5 or those unable to undergo MRI due to claustrophobia or other contraindications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to faster treatment times for patients suffering from acute ischemic stroke, potentially improving recovery outcomes.

How similar studies have performed: Other studies have shown promising results with similar approaches, particularly in improving treatment times for acute ischemic stroke.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years;
2. Can be treated between 4.5-6 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 endovascular thrombectomy;
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 endovascular thrombectomy;
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.

Where this trial is running

Beijing

• Beijing Tiantan Hospital, Capital Medical University — Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Yongjun Wang, MD, PhD — Beijing Tiantan Hospital
• Study coordinator: Yongjun Wang

Conditions: Ischemic Stroke, Acute, Emergency stroke unit, Low-field magnetic resonance imaging, Reperfusion therapy, Endovascular therapy