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To compare the prognosis of patients with hyperacute ischemic stroke (who arrive at the emergency department within 4.5 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).
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 (who arrive at the emergency department within 4.5 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emergency Stroke Unit based on 0.23-T MRI | Experimental | The participants with hyperacute ischemic stroke (arriving at the emergency department within 4.5 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. |
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| Standard stroke unit adherent to guidelines | Placebo Comparator | The participants with hyperacute ischemic stroke (arriving at the emergency department within 4.5 hours of symptom onset) who are eligible to receive reperfusion therapy will be managed by standard stroke unit process adherent to guidelines. |
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| 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 (arriving at the emergency department within 4.5 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The utility-weighted modified Rankin Scale (uw-mRS) 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). | at 90 days (± 7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Ordinal (shift) analysis of modified Rankin Scale (mRS) 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). | at 90 days (± 7 days) |
| Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90 days (± 7 days). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yongjun Wang | Beijing Tiantan Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Capital Medical University | Beijing | 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 (arriving at the emergency department within 4.5 hours of symptom onset) who are eligible to receive reperfusion therapy will be managed by standard stroke unit process adherent to guidelines. |
|
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). |
| at 90 days (± 7 days) |
| Good functional outcome (Modified Rankin Scale score, mRS 0-2) 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). | at 90 days (± 7 days) |
| A 30% reduction (improvement) 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. | from baseline to 24 hours in the NIHSS score. |
| The time from symptoms onset to intravenous thrombolysis decision. | The time from symptoms onset to intravenous thrombolysis decision. | up to 4.5 hours from symptom onset |
| The time from emergency department arrival to intravenous thrombolysis decision. | The time from emergency department arrival to intravenous thrombolysis decision. | up to 4.5 hours from symptom onset. |
| Proportion of participants ultimately treated with reperfusion therapy (separated rate of intravenous thrombolysis / endovascular thrombectomy / bridging therapy). | Proportion of participants ultimately treated with reperfusion therapy (separated rate of intravenous thrombolysis / endovascular thrombectomy [within 6 hours from symptom onset / all patients] / bridging therapy). | up to 6 hours from symptom onset. |
| The time from emergency department arrival to the start of intravenous thrombolysis. | The time from emergency department arrival to the start of intravenous thrombolysis. | up to 4.5 hours from symptom onset |
| The cost-effectiveness analysis. | Cost Effectiveness as measured by average patient QALYs, post-stroke healthcare utilization, incremental fixed costs associated with the ESU. | up to 3 months from enrollment. |
| 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 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). | at 90 days (± 7 days). |
| Mortality at 90 days (± 7 days). | at 90 days (± 7 days). |
| Adverse events at 90 days (± 7 days). | at 90 days (± 7 days). |
| Serious adverse events at 90 days (± 7 days). | at 90 days (± 7 days). |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |