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-label, non-randomized, single-arm study aims to evaluate the safety and efficacy of the ESU workflow using lfMRI in shortening the DNT/DPT and improving functional outcomes in AIS patients, who are eligible for IVT and/or EVT and can be treated within 6 hours after onset, compared with standard practice in Hong Kong; to reveal the changes in the ischemic lesions over a few days after IVT/EVT in these patients, with serial follow-up lfMRI exams.
Age ≥18 years;
Diagnosed as ischemic stroke;
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);
Presenting to AED during working hours (8AM to 6PM, weekdays);
Patients with unstable vital signs who need urgent medical interventions/care;
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;
Claustrophobia or other conditions that are contraindicated for MRI;
Patients with pacemakers, brain stimulators or insulin pumps;
Single group
Portable Magnetic Resonance Imaging
Device0.23T Low-field Magnetic Resonance Imaging
Door-to-Needle time(min) for intravenous thrombolysis
Reduction in the Door-to-Needle time(min) for intravenous thrombolysis
Door-to-Groin Puncture time (min) for endovascular thrombectomy (EVT)
Reduction in the Door-to-Groin Puncture time (min) for endovascular thrombectomy
Time from symptom onset to decision for IVT/EVT (min)
Reduction in time from symptom onset to decision for IVT/EVT (min)
Time from admission to decision for IVT/EVT (min)
Reduction in time from admission to decision for IVT/EVT (min)
Improvement in NIHSS score at 24 hours compared to baseline
30% improvement in NIHSS score at 24 hours compared to baseline
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Chinese University of Hong Kong
Lead sponsor
Beijing Tiantan Hospital
Collaborator