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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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Chinese University of Hong Kong
Coordinator of this site? Confirm its status
Hong KongHong KongRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.