RecruitingPhase 3NCT06522282

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 )


Sponsor

Beijing Tiantan Hospital

Enrollment

600 participants

Start Date

Aug 10, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • Age ≥ 18 years;
  • 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);
  • Presenting with ischemic stroke symptoms;
  • Pre-stroke mRS score 0-1;
  • Baseline NIHSS score ≥ 5;
  • Eligible for endovascular thrombectomy;
  • Informed consent signed.

Exclusion Criteria8

  • Baseline NIHSS score < 5;
  • Unable to undergo MRI because of claustrophobia;
  • Patients with cardiac pacemaker/brain pacemaker/insulin pump implantation;
  • Definite contraindication for endovascular thrombectomy;
  • 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.

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Interventions

COMBINATION_PRODUCTEmergency 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_PRODUCTStandard 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.


Locations(1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, China

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NCT06522282


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