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Completed

NCT Number: NCT06492239

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

To compare the door-to-needle time of patients with hyperacute ischemic stroke (within 4.5 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).

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Key information

Conditions

Ischemic Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

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, Beijing Municipality, 100070, China

About this study

Intravenous thrombolysis is an effective reperfusion therapy for patients with acute ischemic stroke. Faster door-to-needle time (DNT) 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-needle time of patients with hyperacute ischemic stroke (within 4.5 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 within 4.5 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 rt-PA/TNK thrombolysis;
  • 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 rt-PA/TNK thrombolysis;
  • 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 (symptoms onset ≤4.5 h) 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 (symptoms onset ≤4.5 h) who are eligible to receive reperfusion therapy will be managed by standard stroke unit process adherent to guidelines.

Primary outcomes

  1. Door-to-needle time

    Time frame: Door-to-needle time

    The time from emergency department arrival to the start of intravenous thrombolysis.

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 utility-weighted modified Rankin Scale (uw-mRS) at 90±7 days.

    Time frame: at 90±7 days.

    The utility-weighted modified Rankin Scale (uw-mRS) at 90±7 days. Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).

  6. Ordinal (shift) analysis of modified Rankin Scale (mRS) at 90±7 days.

    Time frame: at 90±7 days.

    Ordinal (shift) analysis of modified Rankin Scale (mRS) at 90±7 days. Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).

  7. Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90±7 days.

    Time frame: at 90±7 days.

    Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90±7 days. Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).

  8. Good functional outcome (Modified Rankin Scale score, mRS 0-2) at 90±7 days

    Time frame: at 90±7 days.

    Good functional outcome (Modified Rankin Scale score, mRS 0-2) at 90±7 days. Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).

  9. The time from symptoms onset to intravenous thrombolysis decision.

    Time frame: The time from symptoms onset to intravenous thrombolysis decision.

  10. The time from emergency department arrival to intravenous thrombolysis decision.

    Time frame: The time from emergency department arrival to intravenous thrombolysis decision.

  11. 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).

  12. 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).

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

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

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

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

  15. 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).

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2024
Registry last updated
Mar 4, 2025

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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