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Emergency Stroke Unit for Acute Cerebrovascular Events: A Prospective, Single-arm Trial With a Historical Control Group

RecruitingNAAges 18 Years - 100 YearsAllChinese University of Hong Kong
NCT06728592 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background Reperfusion therapies, i.e., intravenous thrombolysis (IVT) and/or endovascular thrombectomy (EVT), are most effective treatments in the management of acute ischemic stroke (AIS) patients. The benefits of reperfusion therapies, however, may be reduced by treatment delays due to tests and examinations and logistic issues. Emergency Stroke Unit (ESU), a new concept of stroke unit locating at the Accident and Emergency Department (AED), equipped with a mobile, low-field MR imaging (lfMRI) scanner for fast diagnosis of ischemic stroke, differentiation of intracranial hemorrhage and identification of large vessel occlusion (LVO), is being tested in Mainland China. It may shorten the door-to-needle time (DNT) for IVT and door-to-groin puncture time (DPT) for EVT, which may hance associate with improved functional outcomes of AIS patients. This is a prospective, single-center, open-

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age ≥18 years; 2. Diagnosed as ischemic stroke; 3. Eligible for IVT and/or EVT and can be treated within 6 hours of symptom onset (time of symptom onset is defined as the last known normal time); 4. Presenting to AED during working hours (8AM to 6PM, weekdays); 5. Written informed consent from patients or representatives, who understand Cantonese, to participate in this study. Exclusion Criteria: 1. Patients with unstable vital signs who need urgent medical interventions/care; 2. Confirmed contraindications for IVT or EVT by initial assessment (e.g., unstable vital signs, history of severe head trauma within 3 months, known bleeding tendency), before starting brain imaging exams; 3. Claustrophobia or other conditions that are contraindicated for MRI; 4. Patients with pacemakers, brain stimulators or insulin pumps; 5. Patients with medical or other conditions that prevent cooperation with the procedures; 6. Pregnant or breastfeeding women; 7. Participation in other clinical trials within 3 months before screening.
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What it tests

  • Portable Magnetic Resonance Imaging
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Where

1 site
Chinese University of Hong Kong
Hong Kong, Hong Kong
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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