Investigation and Study on the Status of Endovascular Therapy in Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Good Functional Independence
研究概览
简要总结
This study aims to build a database for patients with acute ischemic stroke who receive endovascular therapy and analyze the current situation, effectiveness, safety and cost-effectiveness of endovascular therapy for acute ischemic stroke in China.
详细描述
Study design is a registry, prospective, multicenter study of acute ischemic stroke patients with endovascular treatment. A database will be established including age, gender, smoking history, blood pressure, blood glucose, previous history (such as coronary heart disease, atrial fibrillation, hypertension, diabetes, stroke history, etc.), history of antiplatelet drugs, onset to treatment time, National Institute of Health Stroke Scale (NIHSS) score before treatment.
Indications for endovascular therapy refer to the current guidelines. All patients will receive endovascular therapy, including direct endovascular therapy or intravenous thrombolysis with endovascular therapy. The effectiveness, safety and cost-effectiveness of endovascular therapy for acute ischemic stroke will be analyzed.
This study will enroll up at least 1,000 patients in 70 centers in China. The primary end point are proportion of patients with good prognosis after 90 days and intracranial hemorrhage transformation type after 24 hours.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke
- •Age ≥18 years
- •ICA or MCA-M1 or MCA-M2 occlusion as evidenced by MRA or 4D-CTA
- •Ethrombectomy can be initiated (femoral puncture) within 6 hours after onset or between 6 and 24 hours after time last know well if conform to the imaging inclusion criteria: Target Mismatch Profile on CT perfusion or MR perfusion: ischemic core volume is ≤ 70 ml, mismatch ratio is ≥ 1.8, penumbra volume is ≥ 15 ml.
排除标准
- •Large area cerebral infarction of anterior circulation on early CT image (more than 1/3 of cerebral hemisphere)
- •Blood glucose <2.7mmol/L or >22.2mmol/L
- •Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 90 days
结局指标
主要结局
Good Functional Independence
时间窗: 90 days
This outcome will look at the proportion of patients with mRS 0-2 at day 90.
Hemorrhage transformation
时间窗: 24-hour
hemorrhage transformation at 24-hour after reperfusion therapy: * Hemorrhagic infarction 1 (HI1) was defined as small petechiae along the margins of the infarct; * Hemorrhagic infarction 2 (HI2) as confluent petechiae within the infarcted area but no space-occupying effect; * Parenchymal hemorrhage (PH1) as blood clots in 30% or less of the infarcted area with some slight space- occupying effect; and * Parenchymal hemorrhage (PH2) as blood clots in more than 30% of the infarcted area with substantial space- occupying effect. * Symptomatic intracranial hemorrhage was defined as blood at any site in the brain on the CT scan.
次要结局
- The incidence of recurrent stroke or other vascular events(90 days)
- Poor outcome(90 days)