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

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).

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke, Acute
• Intervention / Treatment: Combination product: Emergency Stroke Unit based on 0.23-T MRI; Combination product: Standard stroke unit

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 Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jing Jing; Phone Number: 15810312511; Email: jingj_bjttyy@163.com
• Study Contact Backup: Name: Yongjun Wang; Phone Number: 59978555; Email: yongjunwang111@aliyun.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Tiantan Hospital, Capital Medical University
    • Contact: Yongjun Wang, Dr.

Participation Criteria

Eligibility Criteria

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

Description

1. Age ≥ 18 years;
2. Patients who arrive at the emergency department between 4.5-6 hours of symptom onset* (*Symptom onset is defined by the "last seen normal" principle);
3. Presenting with ischemic stroke symptoms;
4. Pre-stroke mRS score 0-1;
5. Baseline NIHSS score ≥ 5;
6. Eligible for endovascular thrombectomy;
7. Informed consent signed.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Combination product: 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.
Placebo Comparator: Standard stroke unit adherent to guidelines; 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.	Combination product: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	at 90 days (± 7 days).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	from baseline to 24 hours in the NIHSS score
The cost-effectiveness analysis.	Cost Effectiveness as measured by average patient QALYs, post-stroke healthcare utilization, incremental fixed costs associated with the ESU.	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).	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).	at 90 days (± 7 days)
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).
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).	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).	at 90 days (± 7 days).
The time from symptoms onset to endovascular thrombectomy decision.	The time from symptoms onset to endovascular thrombectomy decision.	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.	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).	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]).	from baseline to reperfusion therapy

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Study Director: Yongjun Wang, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 27, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Reperfusion therapy; Emergency stroke unit; Low-field magnetic resonance imaging
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Stroke; Emergencies; Ischemic Stroke
• Other Study ID Numbers: KY2024-131-02-D

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
• product manufactured in and exported from the U.S.: No