A Phase 2 interventional study of Emergency Stroke Unit based on 0.23-T MRI and Standard stroke unit adherent to guidelines in Ischemic Stroke, Acute, sponsored by Beijing Tiantan Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-04.
Sponsored by Beijing Tiantan Hospital · Phase 2, Interventional, and Treatment
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).
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).
7,287 studies on the registry are indexed under Stroke; 2,006 are open to participants now.
This study's enrollment of 218 is above the median of 50 across 5,370 interventional studies indexed under Stroke.
Browse Stroke studies →Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 281 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Combination Product: Emergency Stroke Unit based on 0.23-T MRI
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.
Combination Product: Standard stroke unit adherent to guidelines
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.
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.
Door-to-needle time
The time from emergency department arrival to the start of intravenous thrombolysis.
Time frame: Door-to-needle time
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).
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).
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).
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).
The utility-weighted modified Rankin Scale (uw-mRS) 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).
Time frame: at 90±7 days.
Ordinal (shift) analysis of modified Rankin Scale (mRS) 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).
Time frame: at 90±7 days.
Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) 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).
Time frame: at 90±7 days.
Good functional outcome (Modified Rankin Scale score, mRS 0-2) 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).
Time frame: at 90±7 days.
The time from symptoms onset to intravenous thrombolysis decision.
Time frame: The time from symptoms onset to intravenous thrombolysis decision.
The time from emergency department arrival to intravenous thrombolysis decision.
Time frame: The time from emergency department arrival to intravenous thrombolysis decision.
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.
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).
Mortality at 14±2 days (or at discharge, whichever occurs first).
Time frame: at 14±2 days (or at discharge, whichever occurs first).
Adverse events at 14±2 days (or at discharge, whichever occurs first).
Time frame: at 14±2 days (or at discharge, whichever occurs first).
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).
Plan to share: No
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Beijing Tiantan Hospital