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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Brain Diseases; Ischemic Stroke; Stroke, Ischemic; Stroke, Acute; Stroke Hemorrhagic; Intracerebral Hemorrhage; Stroke (CVA) or TIA
• Intervention / Treatment: Device: Portable Magnetic Resonance Imaging

Detailed Description

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.

Objectives:

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.

Methods:

This is a prospective, single-center, open-label, non-randomized, single-arm trial with a historical control group (1:2). In the trial group, the investigators will recruit 100 adult AIS patients presenting during working hours, who are potentially eligible for IVT and/or EVT therapies and can be treated within 6 hours of symptom onset; all workflow will be the same with standard care according to contemporary guidelines, except that patient triage procedures related to diagnosis of ischemic stroke, differentiation of intracranial hemorrhage and identification of LVO will be conducted at ESU using lfMRI. A historical control group of 200 patients managed by standard workflow (using CT brain for imaging assessment), in the 2 years before start of this study, will be drawn from our prospective IVT/EVT registry.

The investigators shall collect clinical data at baseline, 24 hours, 72 hours, 5 days, 7 days, discharge (or 14 days if earlier), and 90 days. Patients will also receive follow-up lfMRI exams at 24 hours, 72 hours, 5 days, 7 days, 14 days (or discharge). The primary outcome is DNT (min) for IVT. Main secondary outcomes include DPT (min) for EVT, proportions of patients receiving IVT and/or EVT therapies, door-to-recanalization time for EVT, mRS and NIHSS at discharge (or 14 days), mRS at 90 days, and costeffectiveness analysis. Main safety outcomes include symptomatic intracranial hemorrhage within 36 hours, before discharge (or 14 days) and within 90 days, and mortality, adverse events, severe adverse events within 90 days. Imaging outcomes include changes of infarct volume over time, and changes/emergence of hemorrhagic transformation.

Significance:

Findings from this project and subsequent efforts could help reshape and improve the efficiency of IVT/EVT patient triage at AED, which will ultimately benefit stroke patients and the stroke care system in Hong Kong and elsewhere.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Wai Hong LEUNG, MD; Phone Number: 852-28902002; Email: drtleung@cuhk.edu.hk
• Study Contact Backup: Name: Xinyi LENG, PhD; Phone Number: 852-28953968; Email: xinyi_leng@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Chinese University of Hong Kong
    • Contact: Thomas Wai Hong LEUNG, MD; Phone Number: 852-28902002; Email: drtleung@cuhk.edu.hk
    • Contact: Xinyi LENG, PhD; Phone Number: 852-28953968; Email: xinyi_leng@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Device: Portable Magnetic Resonance Imaging; 0.23T Low-field Magnetic Resonance Imaging; Other Names: Low-field Magnetic Resonance Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Door-to-Needle time(min) for intravenous thrombolysis	Reduction in the Door-to-Needle time(min) for intravenous thrombolysis	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Door-to-Groin Puncture time (min) for endovascular thrombectomy (EVT)	Reduction in the Door-to-Groin Puncture time (min) for endovascular thrombectomy	Day 0
Time from symptom onset to decision for IVT/EVT (min)	Reduction in time from symptom onset to decision for IVT/EVT (min)	Day 0
Time from admission to decision for IVT/EVT (min)	Reduction in time from admission to decision for IVT/EVT (min)	Day 0
Improvement in NIHSS score at 24 hours compared to baseline	30% improvement in NIHSS score at 24 hours compared to baseline	From Day 0, post treatment, to Day 1.
modified Rankin Scale (mRS)	mRS 0-1 at discharge (or 14±2 days), and at 90±7 days ; mRS 0-2 at discharge (or 14±2 days), and at 90±7 days ; mRS distribution at discharge (or 14±2 days), and at 90±7 days	From Day 0 post treatment, up to 90 Days.
Proportion of patients receiving reperfusion therapy (including standalone IVT, standalone EVT and bridging therapy)	Proportion of patients receiving reperfusion therapy (including standalone IVT, standalone EVT and bridging therapy)	Day 0
Door-to-reperfusion time (min) in EVT	Door-to-reperfusion time (min) in EVT	Day 0

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Thomas Wai Hong LEUNG, MD, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: December 7, 2024
• First Posted (Actual): December 11, 2024

Study Record Updates

• Last Update Posted (Actual): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 25, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Intracranial Hemorrhages; Ischemic Stroke; Hemorrhagic Stroke; Stroke; Ischemia; Brain Diseases; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: Crec No. 2024.400T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No