Stroke and Carotid-Cerebral Vascular Disease After CABG

NCT05036044 | Completed

• 1 other identifier: KY-2021127
• Study Type: observational
• Target: 1,002
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Bypass

Keywords

Neurological complications; Carotid-cerebral artery disease; CABG; CAD

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• the incidence of All-cause death

  7 days, 30 days and 1 year post-CABG

• the incidence of CV-death

  7 days, 30 days and 1 year post-CABG

• the incidence of myocardial infraction

  7 days, 30 days and 1 year post-CABG

• the incidence of repeat revascularization

  7 days, 30 days and 1 year post-CABG

Study Arms (2)

With moderate or severe carotid-cerebral artery disease

moderate (stenosis 50-69%) or severe (stenosis 70-100%) carotid-cerebral artery disease

Without moderate or severe carotid-cerebral artery disease

mild (stenosis 30-49%) or no (stenosis 0-29%) carotid-cerebral artery disease

Eligibility Criteria

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

Study Population

Patients received CABG at the department of cardiac surgery in Ruijin hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Study Officials

• Qiang Zhao, MD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director, Department of Cardiovascular Surgery, Vice President, Ruijin Hospital

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 5, 2021
• Study Start: September 4, 2021
• Primary Completion: January 21, 2023
• Study Completion: May 31, 2023
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)