Stroke and Carotid-Cerebral Vascular Disease After CABG

Study Overview
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Brief Summary
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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.

Official Title
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An Observational Cohort Study of Associations Between Early Neurological Complications（Including Stroke）and Carotid-Cerebral Vascular Disease Among Patients After Coronary Artery Bypass Grafting

Conditions
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Coronary Artery Bypass

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who received CABG at the department of cardiac surgery in our hospital. Surgery that patients received includes both isolated and combined CABG surgery. Includes both cardiopulmonary and non-cardiopulmonary bypass. Exclusion Criteria: Without complete preoperative examination data, such as carotid-cerebral artery CTA, head CT imaging results and so on. Without complete baseline medical history and 7 day post-surgery record.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| With moderate or severe carotid-cerebral artery disease<br>moderate (stenosis 50-69%) or severe (stenosis 70-100%) carotid-cerebral artery disease | |
| Without moderate or severe carotid-cerebral artery disease<br>mild (stenosis 30-49%) or no (stenosis 0-29%) carotid-cerebral artery disease | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of All-cause death | Death from any cause | 7 days, 30 days and 1 year post-CABG | 
| the incidence of CV-death | 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 | 7 days, 30 days and 1 year post-CABG | 
| the incidence of myocardial infraction | 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. | 7 days, 30 days and 1 year post-CABG | 
| the incidence of repeat revascularization | any PCI and CABG. | 7 days, 30 days and 1 year post-CABG | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurological complications, Carotid-cerebral artery disease, CABG, CAD