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

Phase 3

Recruiting

• Conditions: Ischemic Stroke, Acute
• Interventions: Combination Product: Emergency Stroke Unit based on 0.23-T MRI; Combination Product: Standard stroke unit

• Registration Number: NCT06522282
• Lead Sponsor: Beijing Tiantan Hospital

Brief 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).

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 Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-22
• Study First Posted: 2024-07-26
• Study Start: 2024-08-10
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-10-01
• Primary Completion: 2025-12-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

1. Baseline NIHSS score < 5;
2. Unable to undergo MRI because of claustrophobia;
3. Patients with cardiac pacemaker/brain pacemaker/insulin pump implantation;
4. Definite contraindication for endovascular thrombectomy;
5. Patients with postictal hemiparesis (Todd's paralysis) or those with concomitant neurological/psychiatric conditions who are unable or unwilling to cooperate;
6. Pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of trial;
7. Participation in other interventional randomized clinical trials within 3 months before enrollment;
8. Patients deemed unsuitable for participation in this trial by the investigator or those for whom participation in this trial may result in greater risks.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Emergency Stroke Unit based on 0.23-T MRI	Emergency Stroke Unit based on 0.23-T MRI	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 unit adherent to guidelines	Standard stroke unit	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.

Primary Outcome Measures

Name	Time	Method
The utility-weighted modified Rankin Scale (uw-mRS) at 90 days (± 7 days).	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).

Secondary Outcome Measures

Name	Time	Method
Ordinal (shift) analysis of modified Rankin Scale (mRS) at 90 days (± 7 days).	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).
Excellent functional outcome (modified Rankin Scale score, mRS 0-1) at 90 days (± 7 days).	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).
Good functional outcome (Modified Rankin Scale score, mRS 0-2) at 90 days (± 7 days).	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).
A 30% reduction (improvement) from baseline to 24 hours in the NIHSS score.	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.
The time from symptoms onset to endovascular thrombectomy decision.	from baseline to reperfusion therapy	The time from symptoms onset to endovascular thrombectomy decision.
The time from emergency department arrival to endovascular thrombectomy decision.	from baseline to reperfusion therapy	The time from emergency department arrival to endovascular thrombectomy decision.
Proportion of participants ultimately treated with reperfusion therapy.	from baseline to 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).
The time from emergency department arrival to the puncture of endovascular thrombectomy.	from baseline to reperfusion therapy	The time from emergency department arrival to the puncture of endovascular thrombectomy (Door-to-puncture time \[DPT\]).
The cost-effectiveness analysis.	up to 3 months from enrollment.	Cost Effectiveness as measured by average patient QALYs, post-stroke healthcare utilization, incremental fixed costs associated with the ESU.
Symptomatic intracranial hemorrhages (according to the ECASS III criteria) within 36 hours.	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).
Symptomatic intracranial hemorrhages (according to the ECASS III criteria) at 90 days (± 7 days).	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).
Mortality at 90 days (± 7 days).	at 90 days (± 7 days).
Adverse events at 90 days (± 7 days).	at 90 days (± 7 days).
Serious adverse events at 90 days (± 7 days).	at 90 days (± 7 days).

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, China