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

NCT ID: NCT06492239

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-26
• Study Completion Date: 2025-01-31

Brief Summary

To compare the door-to-needle time of patients with hyperacute ischemic stroke (within 4.5 hours after the onset of symptoms) 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

Intravenous thrombolysis is an effective reperfusion therapy for patients with acute ischemic stroke. Faster door-to-needle time (DNT) is associated with significantly better clinical outcomes. With the development of low-field magnetic resonance imaging, it is poised to play an increasingly significant role in the early diagnosis and management of acute ischemic stroke. This prospective, multicenter, week-wise randomized controlled trial will compare the door-to-needle time of patients with hyperacute ischemic stroke (within 4.5 hours after the onset of symptoms) 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Emergency Stroke Unit based on 0.23-T MRI

The participants with hyperacute ischemic stroke (symptoms onset ≤4.5 h) who are eligible to receive reperfusion therapy will be managed by Emergency Stroke Unit process based on low-field magnetic resonance imaging.

Group Type: EXPERIMENTAL

Emergency Stroke Unit based on 0.23-T MRI

Intervention Type: COMBINATION_PRODUCT

The participants with hyperacute ischemic stroke (symptoms onset ≤4.5 h) 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

The participants with hyperacute ischemic stroke (symptoms onset ≤4.5 h) who are eligible to receive reperfusion therapy will be managed by standard stroke unit process adherent to guidelines.

Group Type: PLACEBO_COMPARATOR

Standard stroke unit adherent to guidelines

Intervention Type: COMBINATION_PRODUCT

The participants with hyperacute ischemic stroke (symptoms onset ≤4.5 h) who are eligible to receive reperfusion therapy will be managed by standard stroke unit process adherent to guidelines.

Interventions

Emergency Stroke Unit based on 0.23-T MRI

The participants with hyperacute ischemic stroke (symptoms onset ≤4.5 h) who are eligible to receive reperfusion therapy will be managed by Emergency Stroke Unit process based on low-field magnetic resonance imaging.

Intervention Type: COMBINATION_PRODUCT

Standard stroke unit adherent to guidelines

The participants with hyperacute ischemic stroke (symptoms onset ≤4.5 h) who are eligible to receive reperfusion therapy will be managed by standard stroke unit process adherent to guidelines.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years;

2. Can be treated within 4.5 hours of symptoms 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 rt-PA/TNK thrombolysis;

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 rt-PA/TNK thrombolysis;

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yongjun Wang

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yongjun Wang

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

KY2024-131-02-A

Identifier Type: -

Identifier Source: org_study_id