Ischemic Stroke, AcutePhase 3NCT06522282
Emergency Stroke Unit for Acute Cerebrovascular Events ( ESU-ACE-D )
A Phase 3 study testing Emergency Stroke Unit based on 0.23-T MRI and Standard stroke unit in people with Ischemic Stroke, Acute, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
To compare the prognosis of patients with hyperacute ischemic stroke (arriving at the emergency department between 4.5-6 hours of symptom onset) managed in a standard stroke unit adherent to guidelines versus managed in Emergency Stroke Unit (a new stroke unit based on low-field magnetic resonance imaging). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Acute
- What is being tested?
- Emergency Stroke Unit based on 0.23-T MRI and Standard stroke unit
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2024to 1 Mar 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Baseline NIHSS score < 5;
- Unable to undergo MRI because of claustrophobia;
- Patients with cardiac pacemaker/brain pacemaker/insulin pump implantation;
- Definite contraindication for endovascular thrombectomy;
- Patients with postictal hemiparesis (Todd's paralysis) or those with concomitant neurological/psychiatric conditions who are unable or unwilling to cooperate;
- Pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of trial;
- Participation in other interventional randomized clinical trials within 3 months before enrollment;
- Patients deemed unsuitable for participation in this trial by the investigator or those for whom participation in this trial may result in greater risks.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing
Yongjun Wang, Dr.
About this study
Official title: Emergency Stroke Unit for Acute Cerebrovascular Events--A Prospective, Multicenter, Week-wise Randomized, Controlled Trial ( ESU-ACE-D )
To compare the prognosis of patients with hyperacute ischemic stroke (arriving at the emergency department between 4.5-6 hours of symptom onset) managed in a standard stroke unit adherent to guidelines versus managed in Emergency Stroke Unit (a new stroke unit based on low-field magnetic resonance imaging).
Read the detailed description
The first MRI machines in the 1970s and 1980s were low-field due to technological limitations. As technology advanced, the focus shifted to higher field strengths to achieve better image resolution and faster scan times. Recently, there has been renewed interest in low-field MRI due to advancements in hardware and software, making them more viable for specific clinical applications, including acute stroke. Prompt and accurate imaging is crucial for diagnosing ischemic stroke and determining the appropriate treatment (e.g., thrombolysis or thrombectomy). Research has demonstrated that low-field MRI can effectively detect acute ischemic changes and distinguish between ischemic and hemorrhagic stroke. By providing accessible, cost-effective, and safe imaging, it can facilitate timely and accurate treatment, particularly in settings where high-field MRI is not readily available. This prospective, multicenter, week-wise randomized controlled trial will compare the prognosis of patients with hyperacute ischemic stroke (arriving at the emergency department between 4.5-6 hours of symptom onset) managed in a standard stroke unit adherent to guidelines versus managed in Emergency Stroke Unit (a new stroke unit based on low-field magnetic resonance imaging).
- Conditions
- Ischemic Stroke, Acute
- Being tested
- Emergency Stroke Unit based on 0.23-T MRI, Standard stroke unit
- Keywords
- Emergency stroke unit, Low-field magnetic resonance imaging, Reperfusion therapy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency Stroke Unit based on 0.23-T MRICombination product
The participants with hyperacute ischemic stroke (arriving at the emergency department between 4.5-6 hours of symptom onset) who are eligible to receive reperfusion therapy will be managed by Emergency Stroke Unit process based on low-field magnetic resonance imaging.
Standard stroke unitCombination product
The participants with hyperacute ischemic stroke (arriving at the emergency department between 4.5-6 hours of symptom onset) who are eligible to receive reperfusion therapy will be managed by standard stroke unit process adherent to guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Emergency Stroke Unit based on 0.23-T MRI | Experimental | The participants with hyperacute ischemic stroke (arriving at the emergency department between 4.5-6 hours of symptom onset) who are eligible to receive reperfusion therapy will be managed by Emergency Stroke Unit process based on low-field magnetic resonance imaging. Receives: Combination Product: Emergency Stroke Unit based on 0.23-T MRI |
| Standard stroke unit adherent to guidelines | Placebo comparator | The participants with hyperacute ischemic stroke (arriving at the emergency department between 4.5-6 hours of symptom onset) who are eligible to receive reperfusion therapy will be managed by standard stroke unit process adherent to guidelines. Receives: Combination Product: Standard stroke unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
The utility-weighted modified Rankin Scale (uw-mRS) at 90 days (± 7 days).
The utility-weighted modified Rankin Scale (uw-mRS) at 90 days (± 7 days). Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).
Measured: at 90 days (± 7 days).
Secondary outcomes (14)
Ordinal (shift) analysis of modified Rankin Scale (mRS) at 90 days (± 7 days).
Ordinal (shift) analysis of modified Rankin Scale (mRS) at 90 days (± 7 days). Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).
Measured: at 90 days (± 7 days).
Excellent functional outcome (modified Rankin Scale score, mRS 0-1) at 90 days (± 7 days).
Excellent functional outcome (modified Rankin Scale score, mRS 0-1) at 90 days (± 7 days). Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).
Measured: at 90 days (± 7 days)
Good functional outcome (Modified Rankin Scale score, mRS 0-2) at 90 days (± 7 days).
Good functional outcome (modified Rankin Scale score, mRS 0-2) at 90 days (± 7 days). Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).
Measured: at 90 days (± 7 days).
A 30% reduction (improvement) from baseline to 24 hours in the NIHSS score.
A 30% reduction (improvement) from baseline to 24 hours in the NIHSS score. Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating greater neurological deficits.
Measured: from baseline to 24 hours in the NIHSS score
The time from symptoms onset to endovascular thrombectomy decision.
The time from symptoms onset to endovascular thrombectomy decision.
Measured: from baseline to reperfusion therapy
The time from emergency department arrival to endovascular thrombectomy decision.
The time from emergency department arrival to endovascular thrombectomy decision.
Measured: from baseline to reperfusion therapy
Proportion of participants ultimately treated with reperfusion therapy.
Proportion of participants ultimately treated with reperfusion therapy (separated rate of intravenous thrombolysis / endovascular thrombectomy[within 6 hours from symptom onset to treatment; all] / bridging therapy).
Measured: from baseline to reperfusion therapy
The time from emergency department arrival to the puncture of endovascular thrombectomy.
The time from emergency department arrival to the puncture of endovascular thrombectomy (Door-to-puncture time [DPT]).
Measured: from baseline to reperfusion therapy
The cost-effectiveness analysis.
Cost Effectiveness as measured by average patient QALYs, post-stroke healthcare utilization, incremental fixed costs associated with the ESU.
Measured: up to 3 months from enrollment.
Symptomatic intracranial hemorrhages (according to the ECASS III criteria) within 36 hours.
Symptomatic intracranial hemorrhages within 36 hours (sICH definition: according to the ECASS III criteria: any apparently extravascular blood in the brain or within the cranium that was associated with clinical deterioration, as defined by an increase of 4 points or more in the score on the NIHSS, or that led to death and that was identified as the predominant cause of the neurological deterioration).
Measured: within 36 hours
Symptomatic intracranial hemorrhages (according to the ECASS III criteria) at 90 days (± 7 days).
Symptomatic intracranial hemorrhages at 90 days (± 7 days) (sICH definition: according to the ECASS III criteria: any apparently extravascular blood in the brain or within the cranium that was associated with clinical deterioration, as defined by an increase of 4 points or more in the score on the NIHSS, or that led to death and that was identified as the predominant cause of the neurological deterioration).
Measured: at 90 days (± 7 days)
Mortality at 90 days (± 7 days).
Measured: at 90 days (± 7 days).
Adverse events at 90 days (± 7 days).
Measured: at 90 days (± 7 days).
Serious adverse events at 90 days (± 7 days).
Measured: at 90 days (± 7 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start10 Aug 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongjun Wang, Beijing Tiantan Hospital
- Investigators
- Yongjun Wang, Study director, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522282
- Sponsor's protocol ID
- KY2024-131-02-D
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Stroke Unit for Acute Cerebrovascular Events--A Prospective, Multicenter, Week-wise Randomized, Controlled Trial ( ESU-ACE-D )
- ClinicalTrials.gov ID
- NCT06522282
- Acronym / sponsor ID
- KY2024-131-02-D
- Conditions
- Ischemic Stroke, Acute
- Keywords
- Emergency stroke unit, Low-field magnetic resonance imaging, Reperfusion therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 26 Jul 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.
To compare the prognosis of patients with hyperacute ischemic stroke (arriving at the emergency department between 4.5-6 hours of symptom onset) managed in a standard stroke unit adherent to guidelines versus managed in Emergency Stroke Unit (a new stroke unit based on low-field magnetic resonance imaging).
Detailed description
The first MRI machines in the 1970s and 1980s were low-field due to technological limitations. As technology advanced, the focus shifted to higher field strengths to achieve better image resolution and faster scan times. Recently, there has been renewed interest in low-field MRI due to advancements in hardware and software, making them more viable for specific clinical applications, including acute stroke. Prompt and accurate imaging is crucial for diagnosing ischemic stroke and determining the appropriate treatment (e.g., thrombolysis or thrombectomy). Research has demonstrated that low-field MRI can effectively detect acute ischemic changes and distinguish between ischemic and hemorrhagic stroke. By providing accessible, cost-effective, and safe imaging, it can facilitate timely and accurate treatment, particularly in settings where high-field MRI is not readily available. This prospective, multicenter, week-wise randomized controlled trial will compare the prognosis of patients with hyperacute ischemic stroke (arriving at the emergency department between 4.5-6 hours of symptom onset) managed in a standard stroke unit adherent to guidelines versus managed in Emergency Stroke Unit (a new stroke unit based on low-field magnetic resonance imaging).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emergency Stroke Unit based on 0.23-T MRI | Experimental | Combination Product: Emergency Stroke Unit based on 0.23-T MRIThe participants with hyperacute ischemic stroke (arriving at the emergency department between 4.5-6 hours of symptom onset) who are eligible to receive reperfusion therapy will be managed by Emergency Stroke Unit process based on low-field magnetic resonance imaging. |
| Standard stroke unit adherent to guidelines | Placebo comparator | Combination Product: Standard stroke unitThe participants with hyperacute ischemic stroke (arriving at the emergency department between 4.5-6 hours of symptom onset) who are eligible to receive reperfusion therapy will be managed by standard stroke unit process adherent to guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Baseline NIHSS score < 5;
- Unable to undergo MRI because of claustrophobia;
- Patients with cardiac pacemaker/brain pacemaker/insulin pump implantation;
- Definite contraindication for endovascular thrombectomy;
- Patients with postictal hemiparesis (Todd's paralysis) or those with concomitant neurological/psychiatric conditions who are unable or unwilling to cooperate;
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 |
|---|---|---|
| Emergency Stroke Unit based on 0.23-T MRIThe participants with hyperacute ischemic stroke (arriving at the emergency department between 4.5-6 hours of symptom onset) who are eligible to receive reperfusion therapy will be managed by Emergency Stroke Unit process based on low-field magnetic resonance imaging. | Combination product | Emergency Stroke Unit based on 0.23-T MRI |
| Standard stroke unitThe participants with hyperacute ischemic stroke (arriving at the emergency department between 4.5-6 hours of symptom onset) who are eligible to receive reperfusion therapy will be managed by standard stroke unit process adherent to guidelines. | Combination product | Standard stroke unit adherent to guidelines |
Primary outcome
The utility-weighted modified Rankin Scale (uw-mRS) at 90 days (± 7 days).
Time frame: at 90 days (± 7 days).
The utility-weighted modified Rankin Scale (uw-mRS) at 90 days (± 7 days). Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).
14 secondary outcomes
Ordinal (shift) analysis of modified Rankin Scale (mRS) at 90 days (± 7 days).
Time frame: at 90 days (± 7 days).
Excellent functional outcome (modified Rankin Scale score, mRS 0-1) at 90 days (± 7 days).
Time frame: at 90 days (± 7 days)
Good functional outcome (Modified Rankin Scale score, mRS 0-2) at 90 days (± 7 days).
Time frame: at 90 days (± 7 days).
A 30% reduction (improvement) from baseline to 24 hours in the NIHSS score.
Time frame: from baseline to 24 hours in the NIHSS score
The time from symptoms onset to endovascular thrombectomy decision.
Time frame: from baseline to reperfusion therapy
The time from emergency department arrival to endovascular thrombectomy decision.
Time frame: from baseline to reperfusion therapy
Proportion of participants ultimately treated with reperfusion therapy.
Time frame: from baseline to reperfusion therapy
The time from emergency department arrival to the puncture of endovascular thrombectomy.
Time frame: from baseline to reperfusion therapy
The cost-effectiveness analysis.
Time frame: up to 3 months from enrollment.
Symptomatic intracranial hemorrhages (according to the ECASS III criteria) within 36 hours.
Time frame: within 36 hours
Symptomatic intracranial hemorrhages (according to the ECASS III criteria) at 90 days (± 7 days).
Time frame: at 90 days (± 7 days)
Mortality at 90 days (± 7 days).
Time frame: at 90 days (± 7 days).
Adverse events at 90 days (± 7 days).
Time frame: at 90 days (± 7 days).
Serious adverse events at 90 days (± 7 days).
Time frame: at 90 days (± 7 days).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- 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. This study is not recruiting at the moment.
Yongjun Wang study director
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Emergency Stroke Unit based on 0.23-T MRI and Standard stroke unit in people with Ischemic Stroke, Acute, run by Beijing Tiantan Hospital at 1 site in China.
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 0 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 1 Oct 2024. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongjun Wang (59978555, yongjunwang111@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The utility-weighted modified Rankin Scale (uw-mRS) at 90 days (± 7 days). (time frame: at 90 days (± 7 days).). 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 1 Oct 2024.