Ischemic StrokeESU-ACE-ENCT06728592
Emergency Stroke Unit for Acute Cerebrovascular Events: A Prospective, Single-arm Trial With a Historical Control Group
A study testing Portable Magnetic Resonance Imaging in people with Ischemic Stroke and Intracerebral Hemorrhage, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ischemic Stroke, Intracerebral Hemorrhage, Stroke
- What is being tested?
- Portable Magnetic Resonance Imaging
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Dec 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Chinese University of Hong Kong
Hong Kong
Thomas Wai Hong LEUNG, MD, 852-28902002, drtleung@cuhk.edu.hk
Xinyi LENG, PhD, 852-28953968, xinyi_leng@cuhk.edu.hk
About this study
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.
Read the 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 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 60 adult AIS patients presenting during working hours, who are 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 120 patients managed by standard workflow (using CT brain for imaging assessment), in the 3 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.
- Conditions
- Ischemic Stroke, Intracerebral Hemorrhage, Stroke, Stroke, Acute, Stroke, Ischemic, Stroke Hemorrhagic
- Being tested
- Portable Magnetic Resonance Imaging
- Medical subject headings
- Ischemic Stroke, Cerebral Hemorrhage, Stroke, Hemorrhagic Stroke, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable Magnetic Resonance ImagingDevice
Also called Low-field Magnetic Resonance Imaging
0.23T Low-field Magnetic Resonance Imaging
| Study group | Role | What they receive |
|---|---|---|
| Acute ischemic stroke patients , eligible for IVT and/or EVT | Experimental | Acute ischemic stroke patients who are 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. Receives: Device: Portable Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Door-to-Needle time(min) for intravenous thrombolysis
Reduction in the Door-to-Needle time(min) for intravenous thrombolysis
Measured: Day 0
Secondary outcomes (6)
Door-to-Groin Puncture time (min) for endovascular thrombectomy (EVT)
Reduction in the Door-to-Groin Puncture time (min) for endovascular thrombectomy
Measured: Day 0
Time from symptom onset to decision for IVT/EVT (min)
Reduction in time from symptom onset to decision for IVT/EVT (min)
Measured: Day 0
Time from admission to decision for IVT/EVT (min)
Reduction in time from admission to decision for IVT/EVT (min)
Measured: Day 0
Improvement in NIHSS score at 24 hours compared to baseline
30% improvement in NIHSS score at 24 hours compared to baseline
Measured: 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
Measured: From Day 0 post treatment, up to 90 Days.
Door-to-reperfusion time (min) in EVT
Door-to-reperfusion time (min) in EVT
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start2 Dec 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Principal investigator, Leung Wai Hong Thomas, Chinese University of Hong Kong
- Investigators
- Thomas Wai Hong LEUNG, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728592
- Sponsor's protocol ID
- Crec No. 2024.400T
- Acronym
- ESU-ACE-E
- Status last verified
- Sep 2026
- First submitted
- 5 Dec 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Stroke Unit for Acute Cerebrovascular Events: A Prospective, Single-arm Trial With a Historical Control Group
- ClinicalTrials.gov ID
- NCT06728592
- Acronym / sponsor ID
- ESU-ACE-E / Crec No. 2024.400T
- Conditions
- Ischemic Stroke, Intracerebral Hemorrhage, Stroke, Stroke, Acute, Stroke, Ischemic, Stroke Hemorrhagic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 60 adult AIS patients presenting during working hours, who are 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 120 patients managed by standard workflow (using CT brain for imaging assessment), in the 3 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute ischemic stroke patients , eligible for IVT and/or EVT | Experimental | Device: Portable Magnetic Resonance ImagingAcute ischemic stroke patients who are 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portable Magnetic Resonance ImagingAlso: Low-field Magnetic Resonance Imaging0.23T Low-field Magnetic Resonance Imaging | Device | Acute ischemic stroke patients , eligible for IVT and/or EVT |
Primary outcome
Door-to-Needle time(min) for intravenous thrombolysis
Time frame: Day 0
Reduction in the Door-to-Needle time(min) for intravenous thrombolysis
6 secondary outcomes
Door-to-Groin Puncture time (min) for endovascular thrombectomy (EVT)
Time frame: Day 0
Time from symptom onset to decision for IVT/EVT (min)
Time frame: Day 0
Time from admission to decision for IVT/EVT (min)
Time frame: Day 0
Improvement in NIHSS score at 24 hours compared to baseline
Time frame: From Day 0, post treatment, to Day 1.
modified Rankin Scale (mRS)
Time frame: From Day 0 post treatment, up to 90 Days.
Door-to-reperfusion time (min) in EVT
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Wai Hong LEUNG, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portable Magnetic Resonance Imaging in people with Ischemic Stroke and Intracerebral Hemorrhage, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Wai Hong LEUNG, MD (852-28902002, drtleung@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Door-to-Needle time(min) for intravenous thrombolysis (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.