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临床试验/NCT05036044
NCT05036044已完成不适用

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

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 1,002 人开始时间: 2021年9月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,002
试验地点
1
主要终点
the incidence of 7-day neurological complications

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

the incidence of 7-day neurological complications

时间窗: within 7 days post-CABG

a composite of stroke, delayed awakening, severe delirium

the incidence of 7-day stroke

时间窗: within 7 days post-CABG

including cerebral infarction, cerebral hemorrhage, and hypoxic-ischemic encephalopathy

the incidence of delayed awakening

时间窗: within 48 hours post-CABG

post-surgery patient does not wake up at 48 hours after withdrawing sedative

the incidence of severe delirium

时间窗: within 7 days post-CABG

ICU CAM-II score≥2 points

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Qiang Zhao,MD

Professor and Director, Department of Cardiovascular Surgery, Vice President, Ruijin Hospital

Ruijin Hospital

研究点 (1)

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