NCT06728592Recruiting
Emergency Stroke Unit for Acute Cerebrovascular Events: A Prospective, Single-arm Trial With a Historical Control Group
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 5 Dec 2024
- Start date
- 2 Dec 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Stroke
- NCT number
- NCT06728592
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 2 Dec 2024 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in other clinical trials within 3 months before screening.
Other illness
- 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 medical or other conditions that prevent cooperation with the procedures;
Other
- Patients with unstable vital signs who need urgent medical interventions/care;
- Patients with pacemakers, brain stimulators or insulin pumps;
- Pregnant or breastfeeding women;
Who the study is looking for
- 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);
- Written informed consent from patients or representatives, who understand Cantonese, to participate in this study.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | Hong Kong | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.