跳至主要内容
临床试验/NCT02877745
NCT02877745Unknown不适用

ImpaCt of Sleep-disOrdered breathiNg on Atrial Fibrillation and Perioperative complicationS In Patients unDERgoing Coronary Artery Bypass graFting Surgery

Michael Arzt1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,200
试验地点
1
主要终点
Major Adverse Cardiac and Cerebrovascular Events (MACCE)

研究概览

简要总结

In patients undergoing elective coronary artery bypass grafting (CABG) surgery, coronary artery disease, sleep-disordered breathing (SDB), atrial fibrillation (AF) perioperative atrial fibrillation and complications will be assessed. The primary objective is to determine, whether SDB patients have a higher rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) within 30 days after surgery compared to those without SDB.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing elective CABG surgery at the Department of Cardiac and Thoracic Surgery, University Hospital Regensburg.
  • Written informed consent

排除标准

  • Preoperative use of inotropes or intra aortic balloon pump
  • Severe obstructive pulmonary disease
  • Patients on oxygen therapy, nocturnal positive airway pressure support or mechanical ventilation

结局指标

主要结局

Major Adverse Cardiac and Cerebrovascular Events (MACCE)

时间窗: 30 days

periprocedural and late myocardial infarction (MI), non-fatal stroke and transitory ischemic attack (TIA) as well as all-cause mortality

次要结局

  • postoperative atrial fibrillation (POAF)(30 days after CABG surgery)
  • Stroke(within 1 year after CABG surgery)
  • MACCE(within 1 and 2 years after CABG surgery)
  • Major pulmonary complications(within 30 days as well as 1 and 2 years)

研究者

发起方
Michael Arzt
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michael Arzt

Coordinating Investigator

University Hospital Regensburg

研究点 (1)

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