ClinicalTrials.Veeva

Menu

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

Y

Yongjun Wang

Status and phase

Enrolling
Phase 2

Conditions

Ischemic Stroke, Acute

Treatments

Combination Product: Standard stroke unit adherent to guidelines
Combination Product: Emergency Stroke Unit based on 0.23-T MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT06492265
KY2024-131-02-B

Details and patient eligibility

About

To compare the door-to-puncture time of patients with hyperacute ischemic stroke (between 4.5-6 hours after the onset of symptoms) treated in a standard stroke unit adherent to guidelines versus treated in Emergency Stroke Unit (a new stroke unit based on low-field magnetic resonance imaging).

Full description

Mechanical thrombectomy is an effective reperfusion therapy for patients with acute ischemic stroke due to large vessel occlusion. Faster door-to-puncture time (DPT) 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-puncture time of patients with hyperacute ischemic stroke (between 4.5-6 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).

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age ≥ 18 years;
  2. Can be treated between 4.5-6 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 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups, including a placebo group

Emergency Stroke Unit based on 0.23-T MRI
Experimental group
Description:
The participants with hyperacute ischemic stroke (between 4.5-6 hours after onset of symptoms) who are eligible to receive reperfusion therapy will be managed by Emergency Stroke Unit process based on low-field magnetic resonance imaging.
Treatment:
Combination Product: Emergency Stroke Unit based on 0.23-T MRI
Standard stroke unit adherent to guidelines
Placebo Comparator group
Description:
The participants with hyperacute ischemic stroke (between 4.5-6 hours after onset of symptoms) who are eligible to receive reperfusion therapy will be managed by standard stroke unit process adherent to guidelines.
Treatment:
Combination Product: Standard stroke unit adherent to guidelines

Trial contacts and locations

1

Loading...

Central trial contact

Yongjun Wang; Jing Jing

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems