Biomarkers to Predict Hemorrhage and Outcomes After Endovascular Treatment in Patients With Acute Large Vessel Occlusion
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Hemorrhagic transformation
研究概览
简要总结
The main aim of the biomarkers to predict Hemorrhagic transformation(HT) after endovascular treatment in Acute Ischemic Stroke Patients.
The study has three main parts. During the first part, the investigators propose to conduct an enrollment of patients after thrombectomy in acute Ischemic Stroke and healthy controls. Serum biomarkers levels were analyzed (before and after) endovascular treatment patients and controls respectively.
During the second part, HT was evaluated and classified on cranial computed tomography and/or MRI post- treatment and was considered as symptomatic HT (sHT) if associated with neurological deterioration.
During the third part, the investigators aim to demonstrate the level of biomarkers can significant predict HT and outcomes in stroke patients undergoing revascularization.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be 18 or older;
- •have a clinical diagnosis of acute ischemic stroke
- •a score of 6 or more points on the NIHSS(the National Institutes of Health Stroke Scale);
- •be scheduled to undergo intraarterial (IA) therapy for acute hemispheric stroke;
- •patients eligible for IV alteplase should receive IV alteplase;
- •Intracranial arterial occlusion of the distal intracranial carotid artery, middle (M1/M2) ,anterior (A1/A2) cerebral artery,vertebral artery,basilar artery or posterior cerebral artery,demonstrated with CTA, MRA or DSA;
- •begin intra-arterial therapy within 24 hours of symptom onset;
- •have provided informed consent.
排除标准
- •have any pre-existing illness resulting in a modified Rankin Scale Score of 3 or higher prior to the qualifying stroke;
- •patients with known infectious, inflammatory, or neoplastic diseases at the time of treatment and non-availability of blood samples;
- •are pregnant.
结局指标
主要结局
Hemorrhagic transformation
时间窗: 24 to 72 hours
Hemorrhagic transformation was diagnosed by Computed tomographic scans usually performed 24 to 72 hours after the procedure.Symptomatic intracranial hemorrhage was defined as neurologic deterioration (an increase of 4 or more points in the score on the NIHSS) and evidence of intracranial hemorrhage on imaging studies.
次要结局
- Modified Rankin scale(90 days)
研究者
Ji Xunming,MD,PhD
Principal Investigator
Capital Medical University