Stroke and Carotid-Cerebral Vascular Disease After CABG

Completed

• Conditions: Coronary Artery Bypass

• Registration Number: NCT05036044
• Lead Sponsor: Ruijin Hospital

Brief Summary

Review the data of patients who underwent coronary artery bypass grafting (CABG) at the Department of Cardiovascular Surgery in Ruijin hospital from March 2020 to May 2022, including medical history, head and neck CTA, head CT scan, and early postoperative (within 7 days after surgery) neurological complications (defined as a composite of stroke, delayed awakening and severe delirium) . Case-control and retrospective cohorts were built to explore risk factors of early postoperative neurological complications, And its association with baseline carotid-cerebral vascular disease.

Describe the epidemiological data of early postoperative neurological complications (stroke, delayed awakening, and severe delirium) after CABG surgery (within 7 days after surgery); explore independent risk factors of compound neurological complications, build predictive models; compare the effects of carotid-cerebral artery disease on early postoperative compound neurological complications.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-01
• Study First Submitted QC: 2021-09-01
• Study Start: 2021-09-04
• Study First Posted: 2021-09-05
• Primary Completion: 2023-01-21
• Study Completion: 2023-05-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-07
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1002

Inclusion Criteria

1. Patients who received CABG at the department of cardiac surgery in our hospital.
2. Surgery that patients received includes both isolated and combined CABG surgery.
3. Includes both cardiopulmonary and non-cardiopulmonary bypass.

Exclusion Criteria

1. Without complete preoperative examination data, such as carotid-cerebral artery CTA, head CT imaging results and so on.
2. Without complete baseline medical history and 7 day post-surgery record.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the incidence of 7-day neurological complications	within 7 days post-CABG	a composite of stroke, delayed awakening, severe delirium
the incidence of severe delirium	within 7 days post-CABG	ICU CAM-II score≥2 points
the incidence of 7-day stroke	within 7 days post-CABG	including cerebral infarction, cerebral hemorrhage, and hypoxic-ischemic encephalopathy
the incidence of delayed awakening	within 48 hours post-CABG	post-surgery patient does not wake up at 48 hours after withdrawing sedative

Secondary Outcome Measures

Name	Time	Method
the incidence of repeat revascularization	7 days, 30 days and 1 year post-CABG	any PCI and CABG.
the incidence of All-cause death	7 days, 30 days and 1 year post-CABG	Death from any cause
the incidence of CV-death	7 days, 30 days and 1 year post-CABG	Including death resulting from an acute myocardial infarction , sudden cardiac death, death due to heart failure, death due to stroke, death due to cardiovascular procedures, death due to cardiovascular hemorrhage, and death due to other cardiovascular causes
the incidence of myocardial infraction	7 days, 30 days and 1 year post-CABG	According to the 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials, including CABG-related MI, non CABG-related MI, silent MI and unknown type.

Trial Locations

Locations (1)

Ruijin Hospital Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China