Emergency Stroke Unit for treating acute strokes
Emergency Stroke Unit for Acute Cerebrovascular Events: A Prospective, Single-arm Trial With a Historical Control Group
This study is testing a new Emergency Stroke Unit that uses a mobile MRI to see if it can help treat stroke patients faster and improve their recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06728592 on ClinicalTrials.gov |
What this trial studies
This study evaluates the Emergency Stroke Unit (ESU) concept, which is designed to improve the management of acute ischemic stroke patients by utilizing a mobile low-field MRI scanner for rapid diagnosis and treatment. The ESU is located in the Accident and Emergency Department and aims to reduce delays in administering reperfusion therapies such as intravenous thrombolysis (IVT) and endovascular thrombectomy (EVT). By comparing outcomes with a historical control group, the study seeks to demonstrate improvements in treatment times and functional outcomes for patients treated within six hours of symptom onset.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with ischemic stroke and can be treated within six hours of symptom onset.
Not a fit: Patients with unstable vital signs or contraindications for IVT or EVT will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients experiencing acute ischemic strokes.
How similar studies have performed: While the concept of an Emergency Stroke Unit is innovative, similar studies have shown promise in improving treatment times and outcomes for stroke patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years; 2. Diagnosed as ischemic stroke; 3. Potentially 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.
Where this trial is running
Hong Kong
- Chinese University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Thomas Wai Hong LEUNG, MD — Chinese University of Hong Kong
- Study coordinator: Thomas Wai Hong LEUNG, MD
- Email: drtleung@cuhk.edu.hk
- Phone: 852-28902002
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.