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NCT Number: NCT06522282

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, China

Location status: Recruiting

Location contact

Yongjun Wang, Dr.

CONTACT

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

  • 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 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 (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.

Standard stroke unit

Combination Product

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.

Primary outcomes

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

    Time frame: at 90 days (± 7 days).

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

Secondary outcomes

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

    Time frame: at 90 days (± 7 days).

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

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

    Time frame: at 90 days (± 7 days)

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

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

    Time frame: at 90 days (± 7 days).

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

  4. A 30% reduction (improvement) from baseline to 24 hours in the NIHSS score.

    Time frame: from baseline to 24 hours in the NIHSS score

    A 30% reduction (improvement) from baseline to 24 hours in the NIHSS score. Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating greater neurological deficits.

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

    Time frame: from baseline to reperfusion therapy

    The time from symptoms onset to endovascular thrombectomy decision.

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

    Time frame: from baseline to reperfusion therapy

    The time from emergency department arrival to endovascular thrombectomy decision.

  7. Proportion of participants ultimately treated with reperfusion therapy.

    Time frame: from baseline to reperfusion therapy

    Proportion of participants ultimately treated with reperfusion therapy (separated rate of intravenous thrombolysis / endovascular thrombectomy[within 6 hours from symptom onset to treatment; all] / bridging therapy).

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

    Time frame: from baseline to reperfusion therapy

    The time from emergency department arrival to the puncture of endovascular thrombectomy (Door-to-puncture time [DPT]).

  9. The cost-effectiveness analysis.

    Time frame: up to 3 months from enrollment.

    Cost Effectiveness as measured by average patient QALYs, post-stroke healthcare utilization, incremental fixed costs associated with the ESU.

  10. 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).

  11. Symptomatic intracranial hemorrhages (according to the ECASS III criteria) at 90 days (± 7 days).

    Time frame: at 90 days (± 7 days)

    Symptomatic intracranial hemorrhages at 90 days (± 7 days) (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. Mortality at 90 days (± 7 days).

    Time frame: at 90 days (± 7 days).

  13. Adverse events at 90 days (± 7 days).

    Time frame: at 90 days (± 7 days).

  14. Serious adverse events at 90 days (± 7 days).

    Time frame: at 90 days (± 7 days).

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

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-D )

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 26, 2024
Registry last updated
Oct 1, 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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