Ischemic Stroke, AcutePhase 3NCT06522269

Emergency Stroke Unit for Acute Cerebrovascular Events ( ESU-ACE-C )

A Phase 3 study testing Emergency Stroke Unit based on 0.23-T MRI and Standard stroke unit adherent to guidelines in people with Ischemic Stroke, Acute, run by Beijing Tiantan Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To compare the prognosis of patients with hyperacute ischemic stroke (who arrive at the emergency department within 4.5 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 adherent to guidelines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,622 participants
Where: 1 siteChina
Study dates: 8 Aug 2024to 15 Aug 2025
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

Age ≥ 18 years;
Patients who arrive at the emergency department within 4.5 hours of symptom onset* (*Symptom onset is defined by the "last seen normal" principle);
Presenting with ischemic stroke symptoms;
Pre-stroke mRS score 0-1;
Baseline NIHSS score ≥ 5;
Eligible for rt-PA/TNK thrombolysis;
Informed consent signed.

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 rt-PA/TNK thrombolysis;
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

Beijing Tiantan Hospital, Capital Medical University
Beijing

Other trials in China

About this study

Official title: Emergency Stroke Unit for Acute Cerebrovascular Events--A Prospective, Multicenter, Week-wise Randomized, Controlled Trial ( ESU-ACE-C )

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 (who arrive at the emergency department within 4.5 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 adherent to guidelines
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 within 4.5 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 guidelinesCombination product
The participants with hyperacute ischemic stroke (arriving at the emergency department within 4.5 hours of symptom onset) who are eligible to receive reperfusion therapy will be managed by standard stroke unit process adherent to guidelines.

Study groups in NCT06522269
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 within 4.5 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 within 4.5 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 adherent to guidelines

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 intravenous thrombolysis decision.
The time from symptoms onset to intravenous thrombolysis decision.
Measured: up to 4.5 hours from symptom onset
The time from emergency department arrival to intravenous thrombolysis decision.
The time from emergency department arrival to intravenous thrombolysis decision.
Measured: up to 4.5 hours from symptom onset.
Proportion of participants ultimately treated with reperfusion therapy (separated rate of intravenous thrombolysis / endovascular thrombectomy / bridging therapy).
Proportion of participants ultimately treated with reperfusion therapy (separated rate of intravenous thrombolysis / endovascular thrombectomy [within 6 hours from symptom onset / all patients] / bridging therapy).
Measured: up to 6 hours from symptom onset.
The time from emergency department arrival to the start of intravenous thrombolysis.
The time from emergency department arrival to the start of intravenous thrombolysis.
Measured: up to 4.5 hours from symptom onset
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.

8 Aug 202415 Aug 2025

First posted26 Jul 2024
Study start8 Aug 2024
Primary completion15 Aug 2025
Study completion15 Aug 2025

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: 1,622 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06522269
Sponsor's protocol ID: KY2024-131-02-C
Status last verified: Aug 2024
First submitted: 26 Jun 2024
Last updated: 22 Aug 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2025. 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-C )
ClinicalTrials.gov ID: NCT06522269
Acronym / sponsor ID: KY2024-131-02-C
Conditions: Ischemic Stroke, Acute
Keywords: Emergency stroke unit, Low-field magnetic resonance imaging, Reperfusion therapy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,622 participants (actual)
Lead sponsor: Beijing Tiantan HospitalUniversity, hospital or other
Study start: 8 Aug 2024 (actual)
Primary completion: 15 Aug 2025 (actual)
Study completion: 15 Aug 2025 (actual)
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.

Detailed description

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 within 4.5 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 unit adherent to guidelinesThe participants with hyperacute ischemic stroke (arriving at the emergency department within 4.5 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 (7 listed)

Age ≥ 18 years;
Patients who arrive at the emergency department within 4.5 hours of symptom onset* (*Symptom onset is defined by the "last seen normal" principle);
Presenting with ischemic stroke symptoms;
Pre-stroke mRS score 0-1;
Baseline NIHSS score ≥ 5;

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 rt-PA/TNK thrombolysis;
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 within 4.5 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 unit adherent to guidelinesThe participants with hyperacute ischemic stroke (arriving at the emergency department within 4.5 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 intravenous thrombolysis decision.
Time frame: up to 4.5 hours from symptom onset
The time from emergency department arrival to intravenous thrombolysis decision.
Time frame: up to 4.5 hours from symptom onset.
Proportion of participants ultimately treated with reperfusion therapy (separated rate of intravenous thrombolysis / endovascular thrombectomy / bridging therapy).
Time frame: up to 6 hours from symptom onset.
The time from emergency department arrival to the start of intravenous thrombolysis.
Time frame: up to 4.5 hours from symptom onset
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

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
Individual participant dataSharing planned: No

Related trials for Ischemic Stroke, Acute

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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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RecruitingObservational study
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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?

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 7 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: finished, as of the sponsor's last update on 22 Aug 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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?

On the ClinicalTrials.gov record for NCT06522269.

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 22 Aug 2025.