Clinical Research of Intravenous Thrombolysis for Ischemic Stroke in Northeast of China

Study Overview
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Brief Summary
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This research is based on clinic treatment of intravenous thrombolysis for patients with acute ischemic stroke.By building up a database of these patients, the investigators aim to find some significance between groups by analyzing population information, clinical status and such for better evaluation and optimal treatment decision.

Detailed Description
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With the highest incidence rate,the population in northeast of China is severely tormented by stroke, especially ischemic stroke. The investigators lunch this project by building up a database of detailed information of patients that fits the criteria of intravenous thrombolysis therapy.Including biochemical markers,imaging and follow-up,investigators intend to analysis these data,find factors that contributes to better prognosis,so as to push forward the prevention and control work.

Official Title
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Clinical Research of Intravenous Thrombolysis for Ischemic Stroke in Northeast of China

Conditions
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Ischemic Stroke, Thrombosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of ischemic stroke causing measurable neurological deficit Onset of symptoms <4.5 h before treatment begins Age ≥18 y Exclusion Criteria: Significant head trauma or prior stroke in the previous 3 mo Symptoms suggest SAH Arterial puncture at noncompressible site in previous 7 d History of previous intracranial hemorrhage Intracranial neoplasm, AVM, or aneurysm Recent intracranial or intraspinal surgery Elevated blood pressure (systolic >185 mm Hg or diastolic >110 mm Hg) Active internal bleeding Acute bleeding diathesis, including but not limited to Platelet count <100 000/mm3 Heparin received within 48 h resulting in abnormally elevated aPTT above the upper limit of normal Current use of anticoagulant with INR >1.7 or PT >15 s Current use of direct thrombin inhibitors or direct factor Xa inhibitors with elevated sensitive laboratory tests (eg, aPTT, INR, platelet count, ECT, TT, or appropriate factor Xa activity assays) Blood glucose concentration <50 mg/dL (2.7 mmol/L) CT demonstrates multilobar infarction (hypodensity >1/3 cerebral hemisphere) Relative exclusion criteria Recent experience suggests that under some circumstances, with careful consideration and weighting of risk to benefit, patients may receive fibrinolytic therapy despite ≥1 relative contraindications. Consider risk to benefit of intravenous rtPA administration carefully if any of these relative contraindications is present Only minor or rapidly improving stroke symptoms (clearing spontaneously) Pregnancy Seizure at onset with postictal residual neurological impairments Major surgery or serious trauma within previous 14 d Recent gastrointestinal or urinary tract hemorrhage (within previous 21 d) Recent acute myocardial infarction (within previous 3 mo)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Large artery atherosclerosis(LAA)<br> | |
| Cardiogenic stroke(CS)<br> | |
| Penetrating artery disease(PAD)<br> | |
| Other etiology(OE)<br> | |
| undetermined etiology(UE)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mRS score in 90 days | Using mRS score to evaluate the effective of thrombolysis among different groups. | 90 days | 
| Stroke recurrence within 90 days | Newly onset stroke that the time interval was less than 90 days from the original stroke event was considered as stroke recurrence. Ischemic stroke was defined as acute focal brain or retinal infarction. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular death in 1 year | Death direct from ischemic stroke, hemorrhagic stroke, sudden cardiac death, acute myocardial infarction, heart failure, and other cardiovascular death including cardiac arrhythmia that unrelated to sudden cardiac death, pulmonary embolism, cardiovascular intervention (unrelated to acute MI), ruptured aortic aneurysm, or peripheral arterial disease). | 1 year | 
| Post-stroke disability in 1 year | modified Rankin Scale(mRS)≥3 | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic stroke, thrombolysis