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

NCT04960488 | Completed

• 1 other identifier: M2020062
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carotid Endarterectomy; Coronary Artery Bypass Grafting

Outcome Measures

Primary Outcomes (1)

• Cerebral oxygen saturation

  Cerebral oxygen saturation monitoring

  Intraoperative

Study Arms (2)

carotid endarterectomy and coronary artery bypass grafting

EXPERIMENTAL

carotid endarterectomy and coronary artery bypass grafting

Procedure: carotid endarterectomy and coronary artery bypass grafting

carotid endarterectomy

ACTIVE COMPARATOR

carotid endarterectomy

Procedure: carotid endarterectomy and coronary artery bypass grafting

Interventions

carotid endarterectomy and coronary artery bypass grafting PROCEDURE

carotid endarterectomy and coronary artery bypass grafting

carotid endarterectomy; carotid endarterectomy and coronary artery bypass grafting

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

MeSH Terms

Interventions

Endarterectomy, Carotid; Coronary Artery Bypass

Intervention Hierarchy (Ancestors)

Endarterectomy; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Myocardial Revascularization; Cardiac Surgical Procedures; Vascular Grafting; Thoracic Surgical Procedures

Study Officials

• tao wang

  Peking University Third Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: July 14, 2021
• Study Start: December 1, 2019
• Primary Completion: July 30, 2020
• Study Completion: December 30, 2020
• Last Updated: July 14, 2021

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)