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

NCT06728592 | Recruiting

• 1 other identifier: Crec No. 2024.400T
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Ischemic Stroke; Intracerebral Hemorrhage; Stroke; Stroke, Acute; Stroke, Ischemic; Stroke Hemorrhagic; Stroke (CVA) or TIA; Brain Diseases

Outcome Measures

Primary Outcomes (1)

• Door-to-Needle time(min) for intravenous thrombolysis

  Reduction in the Door-to-Needle time(min) for intravenous thrombolysis

  Day 0

Secondary Outcomes (7)

• Door-to-Groin Puncture time (min) for endovascular thrombectomy (EVT)

  Day 0

• Time from symptom onset to decision for IVT/EVT (min)

  Day 0

• Time from admission to decision for IVT/EVT (min)

  Day 0

• Improvement in NIHSS score at 24 hours compared to baseline

  From Day 0, post treatment, to Day 1.

• modified Rankin Scale (mRS)

  From Day 0 post treatment, up to 90 Days.

Study Arms (1)

Acute ischemic stroke patients , potentially eligible for IVT and/or EVT

EXPERIMENTAL

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.

Device: Portable Magnetic Resonance Imaging

Interventions

Portable Magnetic Resonance Imaging DEVICE

0.23T Low-field Magnetic Resonance Imaging

Also known as: Low-field Magnetic Resonance Imaging

Acute ischemic stroke patients , potentially eligible for IVT and/or EVT

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with unstable vital signs who need urgent medical interventions/care;
• 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 pacemakers, brain stimulators or insulin pumps;
• Patients with medical or other conditions that prevent cooperation with the procedures;
• Pregnant or breastfeeding women;
• Participation in other clinical trials within 3 months before screening.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Beijing Tiantan Hospital: collaborator

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Cerebral Hemorrhage; Stroke; Hemorrhagic Stroke; Brain Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Wai Hong LEUNG, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Wai Hong LEUNG, MD

CONTACT

852-28902002; drtleung@cuhk.edu.hk

Xinyi LENG, PhD

CONTACT

852-28953968; xinyi_leng@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 11, 2024
• Study Start: December 2, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)