跳至主要内容
临床试验/NCT04960488
NCT04960488已完成不适用

Multidisciplinary Collaborative Carotid Endarterectomy and Coronary Artery Bypass Graft Surgery to Optimize the Management of High-risk Patients During the Perioperative Period

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Cerebral oxygen saturation

研究概览

简要总结

This project uses concurrent CEA+CABG combined surgery on high-risk patients with severe carotid artery stenosis and severe coronary artery stenosis. After multidisciplinary preoperative evaluation, intraoperative electrophysiological monitoring, and postoperative management standards, compare CEA+CABG combined operations during the same period And the advantages and disadvantages of a single CABG or CEA operation, the purpose is to explore the best surgical treatment plan, establish an interdisciplinary clinical medicine platform centered on patients with heart and cerebrovascular diseases, and develop a standard procedure and The perioperative management is standard, so it is particularly important and naturally has its advanced significance.

详细描述

This project uses concurrent carotid endarterectomy and coronary artery bypass grafting combined surgery on high-risk patients with severe carotid artery stenosis and severe coronary artery stenosis. After multidisciplinary preoperative evaluation, intraoperative electrophysiological monitoring, and postoperative management standards, compare CEA+CABG combined operations during the same period And the advantages and disadvantages of a single CABG or CEA operation, the purpose is to explore the best surgical treatment plan, establish an interdisciplinary clinical medicine platform centered on patients with heart and cerebrovascular diseases, and develop a standard procedure and The perioperative management is standard, so it is particularly important and naturally has its advanced significance.

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 (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • (1) In patients with symptomatic carotid artery stenosis, the preoperative CTA or DSA, combined with carotid ultrasound and high-resolution magnetic resonance clearly diagnosed the degree of carotid artery stenosis on the responsible side>50%; (2) Patients with asymptomatic carotid artery stenosis before operation CTA or DSA, combined with carotid ultrasound and high-resolution magnetic resonance, clearly diagnosed the carotid artery stenosis rate of the affected side>70%; (3) All patients with carotid artery stenosis were located in the surgically accessible position, without complete carotid artery occlusion or intracranial segment Severe vascular stenosis; (4) The stenosis rate of the left main coronary artery by coronary angiography is more than 70%, or the disease of the three main vessels is more than 50%, and the bridging condition is good.

排除标准

  • (1) The disease is beyond the reach of surgery (such as C2 level or above); (2) The symptoms of hypertension are not effectively controlled before surgery (systolic blood pressure> 180mmHg); (3) Carotid artery stenosis caused by non-atherosclerosis , Such as arteritis, arterial dissection, vascular congenital malformations, etc.; (4) combined with hemorrhagic cerebrovascular diseases such as intracranial aneurysms or vascular malformations; (5) combined with blood system diseases that lead to coagulation dysfunction that cannot be corrected or refused to accept blood and blood Importers of products; (6) Pregnancy or perinatal period.

结局指标

主要结局

Cerebral oxygen saturation

时间窗: Intraoperative

Cerebral oxygen saturation monitoring

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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