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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05036044
Other study ID # KY-2021127
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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