Multidisciplinary CAE and CABG Surgery to Optimize the Management of High-risk Patients During the Perioperative Period

Coronary Artery Bypass Grafting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04960488
• Other study ID #: M2020062
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: December 2019
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• (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.

Exclusion Criteria:(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.

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Related Conditions & MeSH terms

• Carotid Endarterectomy
• Coronary Artery Bypass Grafting

Intervention

Procedure:
• carotid endarterectomy and coronary artery bypass grafting
carotid endarterectomy and coronary artery bypass grafting

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral oxygen saturation	Cerebral oxygen saturation monitoring	Intraoperative