Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To compare the door-to-puncture time of patients with hyperacute ischemic stroke (between 4.5-6 hours after the onset of symptoms) treated in a standard stroke unit adherent to guidelines versus treated in Emergency Stroke Unit (a new stroke unit based on low-field magnetic resonance imaging).
Mechanical thrombectomy is an effective reperfusion therapy for patients with acute ischemic stroke due to large vessel occlusion. Faster door-to-puncture time (DPT) 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-puncture time of patients with hyperacute ischemic stroke (between 4.5-6 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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emergency Stroke Unit based on 0.23-T MRI | Experimental | 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. |
|
| Standard stroke unit adherent to guidelines | Placebo Comparator | 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. |
|
| 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 (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. |
| Measure | Description | Time Frame |
|---|---|---|
| Door-to-puncture time | The time from emergency department arrival to the puncture of endovascular thrombectomy. | Door-to-puncture 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongjun Wang | Contact | 59978555 | yongjunwang111@aliyun.com | |
| Jing Jing | Contact | 15810312511 | jingj_bjttyy@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yongjun Wang, MD, PhD | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Capital Medical University | Recruiting | Beijing | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standard stroke unit adherent to guidelines | Combination Product | 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. |
|
| 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 time from symptoms onset to endovascular thrombectomy decision. | The time from symptoms onset to endovascular thrombectomy decision. |
| The time from emergency department arrival to endovascular thrombectomy decision. | The time from emergency department arrival to endovascular thrombectomy decision. |
| Door-to-reperfusion time | The interval between emergency department arrival and the vascular recanalization. | Door-to-reperfusion time |
| 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 |