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

Browse trials for

• Stroke 7,286
• Ischemic Stroke 2,593
• Emergencies 1,692

Keywords

• Emergency stroke unit
• Low-field magnetic resonance imaging
• Reperfusion therapy
• Endovascular therapy

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 100 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Lead sponsor

Yongjun Wang is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Study arms

• Experimental
  Emergency Stroke Unit based on 0.23-T MRI

  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.

  Combination Product: Emergency Stroke Unit based on 0.23-T MRI

• Placebo comparator
  Standard stroke unit adherent to guidelines

  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.

  Combination Product: Standard stroke unit adherent to guidelines

Interventions

• Combination productEmergency Stroke Unit based on 0.23-T MRI

  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.

• Combination productStandard stroke unit adherent to guidelines

  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

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

   Time frame: Door-to-puncture time

Secondary outcomes

1. The utility-weighted modified Rankin Scale (uw-mRS) 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).

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

2. Ordinal (shift) analysis of modified Rankin Scale (mRS) 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).

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

3. Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) 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).

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

4. Good functional outcome (Modified Rankin Scale score, mRS 0-2) 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).

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

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

   The interval between emergency department arrival and the vascular recanalization.

   Time frame: Door-to-reperfusion time

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

   Time frame: within 36 hours.

9. Symptomatic intracranial hemorrhages (according to the ECASS III criteria) 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).

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

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).

Individual participant data

Plan to share: No