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NCT Number: NCT06492265

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, China

Location status: Recruiting

Location contact

Yongjun Wang, Dr.

CONTACT

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years;
  • Can be treated between 4.5-6 hours of symptoms 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 criteria

  • 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.

Treatment and study plan

Emergency Stroke Unit based on 0.23-T MRI

Combination Product

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.

Standard stroke unit adherent to guidelines

Combination Product

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.

Primary outcomes

  1. Door-to-puncture time

    Time frame: Door-to-puncture time

    The time from emergency department arrival to the puncture of endovascular thrombectomy.

Secondary outcomes

  1. The utility-weighted modified Rankin Scale (uw-mRS) at 14±2 days (or at discharge, whichever occurs first).

    Time frame: at 14±2 days (or at discharge, whichever occurs first).

    The utility-weighted modified Rankin Scale (uw-mRS) at 14±2 days (or at discharge, whichever occurs first). Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).

  2. Ordinal (shift) analysis of modified Rankin Scale (mRS) at 14±2 days (or at discharge, whichever occurs first).

    Time frame: at 14±2 days (or at discharge, whichever occurs first).

    Ordinal (shift) analysis of modified Rankin Scale (mRS) at 14±2 days (or at discharge, whichever occurs first). Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).

  3. Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 14±2 days (or at discharge, whichever occurs first).

    Time frame: at 14±2 days (or at discharge, whichever occurs first).

    Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 14±2 days (or at discharge, whichever occurs first). Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).

  4. Good functional outcome (Modified Rankin Scale score, mRS 0-2) at 14±2 days (or at discharge, whichever occurs first).

    Time frame: at 14±2 days (or at discharge, whichever occurs first).

    Good functional outcome (Modified Rankin Scale score, mRS 0-2) at 14±2 days (or at discharge, whichever occurs first). Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).

  5. The time from symptoms onset to endovascular thrombectomy decision.

    Time frame: The time from symptoms onset to endovascular thrombectomy decision.

  6. The time from emergency department arrival to endovascular thrombectomy decision.

    Time frame: The time from emergency department arrival to endovascular thrombectomy decision.

  7. Door-to-reperfusion time

    Time frame: Door-to-reperfusion time

    The interval between emergency department arrival and the vascular recanalization.

  8. Symptomatic intracranial hemorrhages (according to the ECASS III criteria) within 36 hours.

    Time frame: within 36 hours.

    Symptomatic intracranial hemorrhages within 36 hours (sICH definition: according to the ECASS III criteria: any apparently extravascular blood in the brain or within the cranium that was associated with clinical deterioration, as defined by an increase of 4 points or more in the score on the NIHSS, or that led to death and that was identified as the predominant cause of the neurological deterioration).

  9. Symptomatic intracranial hemorrhages (according to the ECASS III criteria) at 14±2 days (or at discharge, whichever occurs first).

    Time frame: at 14±2 days (or at discharge, whichever occurs first).

    Symptomatic intracranial hemorrhages at 14±2 days (or at discharge, whichever occurs first) (sICH definition: according to the ECASS III criteria: any apparently extravascular blood in the brain or within the cranium that was associated with clinical deterioration, as defined by an increase of 4 points or more in the score on the NIHSS, or that led to death and that was identified as the predominant cause of the neurological deterioration).

  10. Mortality at 14±2 days (or at discharge, whichever occurs first).

    Time frame: at 14±2 days (or at discharge, whichever occurs first).

  11. Adverse events at 14±2 days (or at discharge, whichever occurs first).

    Time frame: at 14±2 days (or at discharge, whichever occurs first).

  12. Serious adverse events at 14±2 days (or at discharge, whichever occurs first).

    Time frame: at 14±2 days (or at discharge, whichever occurs first).

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Jing

CONTACT

[email protected]

15810312511

Yongjun Wang

CONTACT

[email protected]

59978555

Sponsors and collaborators

Lead sponsor

yongjun wang

Other Gov

Registry information

Official study title

Emergency Stroke Unit for Acute Cerebrovascular Events--A Prospective, Multicenter, Week-wise Randomized, Controlled Trial ( ESU-ACE-B )

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2024
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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