Registration of Intravenous Thrombolysis for Acute Ischemic Stroke in Southwestern China（IVTIS）

Study Overview
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Brief Summary
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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.

Detailed Description
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IVTIS is a prospective, real-world registry lasting for 22 years. A total of 3000 patients with intravenous thrombolysis will be enrolled。

Official Title
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Registration of Intravenous Thrombolysis for Acute Ischemic Stroke in Southwestern China（IVTIS）

Conditions
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Stroke, Acute

Intervention / Treatment
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* Drug: intravenous thrombolysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient was diagnosed with acute ischemic stroke and received intravenous thrombolysis. Exclusion Criteria: No additional exclusion criteria.
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute ischemic stroke treated with intravenous thrombolysis<br>All of acute ischemic stroke patients who treated with intravenous thrombolysis. | Drug: intravenous thrombolysis<br>* Intravenous thrombolysis using thrombolytic drugs such as ateplase and teneplase.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |