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

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

Recruiting
18 years and older
All
Phase 3

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Overview

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).

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).

Eligibility

  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 details
    Ischemic Stroke
    Acute

NCT06522282

Beijing Tiantan Hospital

31 August 2025

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