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Current literature has only limited information on the natural history of acute ischemic stroke from large vessel occlusion in a stroke cohort who presents within 8 hours from symptom onset, particularly on 90 day functional outcome as defined by the mRS. Data from this trial will advance our knowledge on this important topic and may serve as a bench mark for future trials
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acute ischemic stroke | Patients presenting with symptoms of acute ischemic stroke within 8 hours from symptom onset and with an imaging-defined large cerebral vessel occlusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Current standard of care for acute ischemic stroke other than IV rtPA or other IA therapies | Other | The objective of this study is to determine the natural history of acute ischemic stroke from large vessel thromboembolism in the brain. Patients with current standard of care other than IV rtPA or IA therapies will be studied. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional outcome at 90 days after presentation as defined by a modified Rankin Score of 0-2. | 90 days after presentation |
| Measure | Description | Time Frame |
|---|---|---|
| • Good neurological recovery as defined by a NIHSS score of 0-1 at discharge or a 10-point or more improvement in this scale at discharge. | Discharge and 90 days after presentation | |
| All cause mortality | Dishcharge and 90 days after presentation |
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Inclusion Criteria:
Exclusion Criteria:
History of stroke in the past 3 months.
Pre-existing neurological or psychiatric disease that could confound the study results such as a pre-stroke mRS score greater than 1
Known severe allergy to contrast media
Uncontrolled hypertension (defined as systolic blood pressure greater than 185 mmHg or diastolic blood pressure less than 110 mmHg)
CT evidence of the following conditions before enrollment:
Treated with endovascular therapy for acute stroke
Life expectancy less than 90 days
Participation in another clinical investigation that could confound the evaluation of the study
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Patients presenting with symptoms of acute ischemic stroke within 8 hours from symptom onset and with an imaging-defined large cerebral vessel occlusion and a known infarct volume will be enrolled and followed for 90-days.
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| Name | Affiliation | Role |
|---|---|---|
| Siu Po Sit, PhD | Penumbra Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Stroke Institute | Plano | Texas | 75075 | United States | ||
| Queen Mary Hospital |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Incidence of symptomatic and asymptomatic hemorrhage | Dishcharge and 90 days after presentation |
| Hong Kong |
| Hong Kong |
| China |
| The Prince of Wales Hospital | Shatin | Hong Kong | China |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |