The Safety and Efficacy of Peri-procedure Blood Pressure Management of Revascularization for Ischemic Cerebral Vascular Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 2,270
- 试验地点
- 2
- 主要终点
- death
研究概览
简要总结
Objective: Referring The relation between CEA(Carotid endarterectomy) postoperative blood flow monitoring and blood pressure, and combining patient demographics and preoperative risk factors to establish an applicable individual blood pressure controlling model. By comparing with routine antihypertensive strategies through prospective randomized controlled trials , to provide the best perioperative blood pressure control standards and strategies for each patient ,thus better ensuring the safety and efficacy of CEA .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •symptomatic patient with carotid artery stenosis>=50% or asymptomatic patient with carotid artery stenosis>=70%, according to DSA or CTA;
- •without massive cerebral infarction(infarction area >1/2 territory of middle cerebral artery) confirmed by CT or MRI;
- •informed consent acquired.
排除标准
- •lesion beyond range limit of procedure (higher than C2);
- •target vascular complete occlusion or ipsilateral intracranial artery severe stenosis or complete occlusion cannot be revascularized via CEA procedure
- •nonatherosclerotic carotid stenosis, such as vasculitis, dissection, congenital vascular malformation;
- •history of instable angina pectoris, myocardial infarction or congestive heart failure within 6 months unable to accept systematic anesthesia;
- •history of severe injury, surgery or radiotherapy on neck;
- •with comorbid hemorrhagic cerebral disease such as intracranial aneurysm or vascular malformation;
- •with comorbid blood system disease causing refractory coagulation dysfunction or rejection to blood or blood products perfusion;
- •with other comorbidity, expected life < 2 years;
- •severe diabetes mellitus difficult to control, blood sugar >300mg/dl;
- •pregnancy or peri-natal period;
- •intolerance to systematic anesthesia or surgery after adequate preparation.
- •intolerance to peri-procedural drug possible to administrated;
- •not cooperating or rejecting to informed consent;
研究组 & 干预措施
model controlling
an statistical model for periprocedural blood pressure control
干预措施: model controlling (Other)
conventional controlling
an conventional strategy for periprocedural blood pressure control
干预措施: conventional controlling (Other)
结局指标
主要结局
death
时间窗: 30 days
all cause death
cardiovascular events
时间窗: 30 days
Cardiovascular events were defined as: ECG presentation clearly different from preoperative myocardial ischemia, myocardial infarction, arrhythmia and cardiovascular death.
ischemic stroke
时间窗: 30 days
Ischemic stroke is defined as an acute episode of neurological events with focal symptoms and signs, with a duration of more than 24h and confirmed by imaging.
次要结局
- transient ischemic attack,TIA(30 days)
- hyperperfusion syndrome(30 days)
- cerebral hemorrhage(30 days)
- epilepsy(30 days)
研究者
lingfeng
clinical investigator
Xuanwu Hospital, Beijing