Clinical trial NCT05036044: Stroke and Carotid-Cerebral Vascular Disease After CABG
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Bypass
Keywords: Neurological complications
Carotid-cerebral artery disease
CABG
CAD
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 1002
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients received CABG at the department of cardiac surgery in 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.


Eligibility criteria: 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.

Primary outcomes:
measure: the incidence of 7-day neurological complications
timeFrame: within 7 days post-CABG
measure: the incidence of 7-day stroke
timeFrame: within 7 days post-CABG
measure: the incidence of delayed awakening
timeFrame: within 48 hours post-CABG
measure: the incidence of severe delirium
timeFrame: within 7 days post-CABG
Secondary outcomes:
measure: the incidence of All-cause death
timeFrame: 7 days, 30 days and 1 year post-CABG
measure: the incidence of CV-death
timeFrame: 7 days, 30 days and 1 year post-CABG
measure: the incidence of myocardial infraction
timeFrame: 7 days, 30 days and 1 year post-CABG
measure: the incidence of repeat revascularization
timeFrame: 7 days, 30 days and 1 year post-CABG
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Qiang Zhao, MD
role: PRINCIPAL_INVESTIGATOR
References: