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

Last updated: September 27, 2024
Sponsor: Beijing Tiantan Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Blood Clots

Stroke

Thrombosis

Treatment

Emergency Stroke Unit based on 0.23-T MRI

Standard stroke unit

Clinical Study ID

NCT06522282
KY2024-131-02-D
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

  1. Age ≥ 18 years;

  2. Patients who arrive at the emergency department between 4.5-6 hours of symptomonset* (*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

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 concomitantneurological/psychiatric conditions who are unable or unwilling to cooperate;

  6. Pregnant women, nursing mothers, or reluctance to use effective contraceptivemeasures during the period of trial;

  7. Participation in other interventional randomized clinical trials within 3 monthsbefore enrollment;

  8. Patients deemed unsuitable for participation in this trial by the investigator orthose for whom participation in this trial may result in greater risks.

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: Emergency Stroke Unit based on 0.23-T MRI
Phase: 3
Study Start date:
August 10, 2024
Estimated Completion Date:
March 01, 2026

Study 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).

Connect with a study center

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing,
    China

    Active - Recruiting

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