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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emergency Stroke Unit based on 0.23-T MRI | Experimental | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Door-to-needle time | The time from emergency department arrival to the start of intravenous thrombolysis. | Door-to-needle time |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | at 14±2 days (or at discharge, whichever occurs first). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yongjun Wang | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Capital Medical University | Beijing | Beijing Municipality | 100070 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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. |
|
| 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). | 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). | 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). | 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). | 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). | 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). | 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). | at 90±7 days. |
| The time from symptoms onset to intravenous thrombolysis decision. | The time from symptoms onset to intravenous thrombolysis decision. |
| The time from emergency department arrival to intravenous thrombolysis decision. | 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). | 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). | at 14±2 days (or at discharge, whichever occurs first). |
| Mortality at 14±2 days (or at discharge, whichever occurs first). | at 14±2 days (or at discharge, whichever occurs first). |
| Adverse events at 14±2 days (or at discharge, whichever occurs first). | at 14±2 days (or at discharge, whichever occurs first). |
| Serious adverse events at 14±2 days (or at discharge, whichever occurs first). | at 14±2 days (or at discharge, whichever occurs first). |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |