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This study aims to observe the safety and effectiveness of intravenous thrombolysis for acute ischemic stroke in real-world clinical practice.
IVTIS is a prospective, real-world registry lasting for 22 years. A total of 3000 patients with intravenous thrombolysis will be enrolled。
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute ischemic stroke treated with intravenous thrombolysis | All of acute ischemic stroke patients who treated with intravenous thrombolysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravenous thrombolysis | Drug | Intravenous thrombolysis using thrombolytic drugs such as ateplase and teneplase. |
|
| Measure | Description | Time Frame |
|---|---|---|
| modified Rankin Scale (mRS) score | Ordinal distribution of mRS at 90±7 days; modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death) | 90±7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Excellent functional outcome | Proportion of subjects with mRS 0-1 at 90±7 days. | 90±7 days |
| Good functional outcome | Proportion of subjects with mRS 0-2 at 90±7 days. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with acute ischemic stroke who received intravenous thrombolysis will be included in the study and no additional exclusion criteria have been set.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhengzhou Yuan, MD | Contact | +868303165661 | coneuro@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhengzhou Yuan | Department of Neurology, Affiliated Hospital of Southwest Medical University, Lu | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Southwest Medical University | Recruiting | Luzhou | 646000 | China |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 90±7 days |
| mRS 0-3 | Proportion of subjects with mRS 0-3 at 90±7 days. | 90±7 days |
| Change of National Institutes of Health Stroke Scale (NIHSS) | Change of National Institutes of Health Stroke Scale (NIHSS, a scale between 0 and 42 on which higher scores indicate more severe neurologic deficits) from baseline to 24 hours. | 24 hours |
| Change of National Institutes of Health Stroke Scale (NIHSS) | Change of National Institutes of Health Stroke Scale (NIHSS, a scale between 0 and 42 on which higher scores indicate more severe neurologic deficits) from baseline to 7 days. | 7 days |
| Symptom-to-thrombolysis time | Time from onset of symptoms to thrombolytic therapy. | 24 hours |
| Door-to-Needle Time | Time from the arrival of stroke patient in emergency to initiation of thrombolysis therapy. | 24 hours |
| Incidence of clinically significant intracranial hemorrhage | Incidence of sICH (Heidelberg criteria) measured at 36 hours | 36 hours |
| Incidence of any intracranial hemorrhage | Incidence of any intracranial hemorrhage (Heidelberg criteria) measured at 36 hours | 36 hours |
| All-cause mortality | All-cause mortality at 90±7 days | 90±7 days |
| Complications related to intravenous thrombolysis | Complications related to intravenous thrombolysis during hospitalization | up to 7 days |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |