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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 potentially 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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Age ≥18 years;

• Diagnosed as ischemic stroke;

• 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);

• 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.

Locations
Other Locations
Hong Kong Special Administrative Region
Chinese University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
Thomas Wai Hong LEUNG, MD
drtleung@cuhk.edu.hk
852-28902002
Backup
Xinyi LENG, PhD
xinyi_leng@cuhk.edu.hk
852-28953968
Time Frame
Start Date: 2024-12-02
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 100
Treatments
Experimental: Acute ischemic stroke patients , potentially eligible for IVT and/or EVT
Acute ischemic stroke patients who are potentially eligible for IVT and/or EVT therapies and can be treated within 6 hours of symptom onset, will be triaged for intravenous thrombolysis (IVT) and/or endovascular thrombectomy (EVT) in Emergency Stroke Unit (ESU) based on lfMRI for diagnosis of ischemic stroke, differentiation of intracerebral hemorrhage (ICH) and identification of large vessel occlusion (LVO). Other screening and assessment procedures for IVT/EVT, and clinical management of the patients, are the same with standard practice as recommended by contemporary guidelines. In the historical control group, patients were triaged for IVT and/or EVT by standard practice, using plain CT and CTA for imaging triage.
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong
Collaborators: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov

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