Intravenous Thrombolysis Guided by Telemedicine Consultation System for Acute Ischemic Stroke Patients in China
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Percentage of patients treated with intravenous thrombolysis
研究概览
简要总结
The purpose is to evaluate the effectiveness and safety profile of telemedicine consultation system in making decision on IV thrombolysis.
详细描述
The rate of intravenous thrombolysis with tissue-type plasminogen activator or urokinase for stroke patients was extremely low in China. It has been demonstrated that telestroke may help to increase the rate of intravenous thrombolysis and improve the stroke care quality in the local hospitals. The aim of this study is to evaluate the effectiveness and safety of decision making of intravenous thrombolysis via telemedicine consultation system for acute ischemic stroke patients in China This trial network consists of one hub hospital (Xijing Hospital) and 14 spoke hospitals in the remote area of Shanxi Province. The telemedicine consultation system is an interactive, 2-way, wireless, audiovisual system based on portable hardwares--tablet computer or smartphone. Before this study, we have been investigating the usual stroke care quality in the spoke hospitals without the guidance from the hub hospital, which will be used as the historical control of this study. After that, the teleconsultation system will be introduced.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years and less than 80 years
- •Acute ischemic stroke
- •Presenting to Emergency Department of spoke hospitals within 4.5 hours of stroke symptom onset
- •National Institutes of Health Stroke Scale (NIHSS) between 4 and 25
- •Signed consent form by the patient or his relatives
排除标准
- •Time of symptom onset unclear
- •Unlikely to complete study through 3-month follow-up
结局指标
主要结局
Percentage of patients treated with intravenous thrombolysis
时间窗: at 4.5 hours
次要结局
- All cause mortality(at 3 months)
- Fatal and nonfatal cardiovascular events(at 7 days)
- Favorite outcome at 3 months (modified Rankin score ≤2)(at 1 month/3 months)
- Time intervals(at 24 hours)
- Stroke complications(at 24 hours/7days)
- Length of hospitalization(at 3 months)