Stroke and Carotid-Cerebral Vascular Disease After CABG

Coronary Artery Bypass Clinical Trial

— SCCAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05036044
• Other study ID #: KY-2021127
• Status: Completed
• Start date: September 4, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: July 2023
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1002
• Est. completion date: May 31, 2023
• Est. primary completion date: January 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Bypass
• Vascular Diseases

Locations

Country	Name	City	State
China	Ruijin Hospital Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of 7-day neurological complications	a composite of stroke, delayed awakening, severe delirium	within 7 days post-CABG
Primary	the incidence of 7-day stroke	including cerebral infarction, cerebral hemorrhage, and hypoxic-ischemic encephalopathy	within 7 days post-CABG
Primary	the incidence of delayed awakening	post-surgery patient does not wake up at 48 hours after withdrawing sedative	within 48 hours post-CABG
Primary	the incidence of severe delirium	ICU CAM-II score=2 points	within 7 days post-CABG
Secondary	the incidence of All-cause death	Death from any cause	7 days, 30 days and 1 year post-CABG
Secondary	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
Secondary	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
Secondary	the incidence of repeat revascularization	any PCI and CABG.	7 days, 30 days and 1 year post-CABG