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

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

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.

Study Overview

• Status: Completed
• Conditions: Carotid Endarterectomy; Coronary Artery Bypass Grafting
• Intervention / Treatment: Procedure: carotid endarterectomy and coronary artery bypass grafting

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: carotid endarterectomy and coronary artery bypass grafting	Procedure: carotid endarterectomy and coronary artery bypass grafting; carotid endarterectomy and coronary artery bypass grafting
ACTIVE_COMPARATOR: carotid endarterectomy	Procedure: carotid endarterectomy and coronary artery bypass grafting; carotid endarterectomy and coronary artery bypass grafting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebral oxygen saturation	Cerebral oxygen saturation monitoring	Intraoperative

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Chair: tao wang, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2019
• Primary Completion (ACTUAL): July 30, 2020
• Study Completion (ACTUAL): December 30, 2020

Study Registration Dates

• First Submitted: July 4, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (ACTUAL): July 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2021
• Last Update Submitted That Met QC Criteria: July 4, 2021
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: M2020062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No