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

What this Trial Is About

Researchers are evaluating a new Emergency Stroke Unit (ESU) located in the Accident and Emergency Department, equipped with a mobile low-field MRI scanner. This approach aims to speed up diagnosis of acute ischemic stroke (AIS), differentiate intracranial hemorrhage, and identify large vessel occlusion. The study compares this ESU workflow with standard practice in Hong Kong to see if it shortens treatment times and improves patient outcomes for those eligible for intravenous thrombolysis (IVT) and/or endovascular thrombectomy (EVT) within 6 hours of stroke onset. The study is a prospective, single-center, open-label, non-randomized, single-arm trial with a historical control group. Eligible patients presenting during working hours will be triaged at the ESU using the low-field MRI for diagnosis and treatment decisions, while all other clinical management follows standard guidelines. A historical group of patients treated with standard CT imaging will serve as a comparison. Patients will receive follow-up MRI scans over the first two weeks to track changes in ischemic lesions after treatment. Participants will undergo clinical assessments at baseline, 24 hours, 72 hours, 5 days, 7 days, discharge (or day 14), and at 90 days. Imaging exams with the low-field MRI will also be done at several time points during the first two weeks. Researchers will measure treatment times such as door-to-needle and door-to-groin puncture times, functional outcomes using scales like the modified Rankin Scale and NIH Stroke Scale, safety outcomes including bleeding and adverse events, and analyze cost-effectiveness. Follow-up will continue for 90 days post-treatment.

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