NCT06728592 Emergency Stroke Unit for Acute Cerebrovascular Events: A Prospective, Single-arm Trial With a Historical Control Group
| NCT ID | NCT06728592 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-12-02 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-12-02 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Thomas Wai Hong LEUNG, MD
PRINCIPAL INVESTIGATOR
Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT06728592 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06728592 currently recruiting?
Yes, NCT06728592 is actively recruiting participants. Contact the research team at drtleung@cuhk.edu.hk for enrollment information.
Where is the NCT06728592 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT06728592 clinical trial?
NCT06728592 is sponsored by Chinese University of Hong Kong. The principal investigator is Thomas Wai Hong LEUNG, MD at Chinese University of Hong Kong. The trial plans to enroll 60 participants.
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