Registration of Intravenous Thrombolysis for Acute Ischemic Stroke in Southwestern China（IVTIS）
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- modified Rankin Scale (mRS) score
研究概览
简要总结
This study aims to observe the safety and effectiveness of intravenous thrombolysis for acute ischemic stroke in real-world clinical practice.
详细描述
IVTIS is a prospective, real-world registry lasting for 22 years. A total of 3000 patients with intravenous thrombolysis will be enrolled。
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient was diagnosed with acute ischemic stroke and received intravenous thrombolysis.
排除标准
- •No additional exclusion criteria.
研究组 & 干预措施
Acute ischemic stroke treated with intravenous thrombolysis
All of acute ischemic stroke patients who treated with intravenous thrombolysis.
干预措施: intravenous thrombolysis (Drug)
结局指标
主要结局
modified Rankin Scale (mRS) score
时间窗: 90±7 days
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)
次要结局
- Incidence of clinically significant intracranial hemorrhage(36 hours)
- Excellent functional outcome(90±7 days)
- Good functional outcome(90±7 days)
- Incidence of any intracranial hemorrhage(36 hours)
- All-cause mortality(90±7 days)
- Complications related to intravenous thrombolysis(up to 7 days)
- mRS 0-3(90±7 days)
- Change of National Institutes of Health Stroke Scale (NIHSS)(7 days)
- Door-to-Needle Time(24 hours)
- Symptom-to-thrombolysis time(24 hours)
研究者
Zhengzhou Yuan
Deputy Director of Stroke Center
The Affiliated Hospital Of Southwest Medical University