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临床试验/NCT02080156
NCT02080156Unknown不适用

Impact of Continuous Positive Airway Pressure Therapy on Outcomes in Patients Undergoing Coronary Revascularization

Beijing Anzhen Hospital1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

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
Mortality

研究概览

简要总结

Investigators assume that continuous positive airway pressure (CPAP) therapy can reduce the mortality, stroke rate and secondary coronary surgery in CAD with obstructive sleep apnea (OSA) patients after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABA) during postoperative follow-up of 3 years.

详细描述

Investigators observe whether continuous positive airway pressure (CPAP) therapy can reduce the mortality, stroke rate and secondary coronary surgery in CAD with OSA patients after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABA) during postoperative follow-up of 3 years. During the 3 years, we randomize all enrolled patients to 2 groups separately beginning CPAP or no-CPAP intervention after sleep monitoring. Guidance for all patients during follow-up 1 week, 2 week, 1 month, 3 month. The follow-up procedure includes clinical assessments at three months, six months, one year, two and three years respectively.The primary outcome variables are prospectively being documented and are not subject to observer bias.Baseline comorbidity data, results of the sleep recordings, compliance with CPAP device, scores of the questionnaires as well as results of the blood analysis are performed and/or documented consecutively in separate files by research personnel blinded to the allocation of the study groups and/or unaware of the results of the concomitant outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Angiography confirmed coronary heart disease (CHD) patients
  • Underwent PCI or coronary artery bypass graft (CABG) in recent the week
  • Signed informed consent
  • Mild-to-moderate OSA(5≤AHI≤100)

排除标准

  • OSA patients who has already started treatment
  • Patients presenting mainly central apnea (≥ 50%)
  • Respiratory insufficiency patients

研究组 & 干预措施

no-CPAP

No Intervention

CPAP vs. no-CPAP in patients undergoing Coronary Revascularization follow-up for 3 years

CPAP

Experimental

CPAP vs. no-CPAP in patients undergoing Coronary Revascularization follow-up for 3 years

干预措施: CPAP (Device)

结局指标

主要结局

Mortality

时间窗: 3 years

次要结局

未报告次要终点

研究者

发起方
Beijing Anzhen Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiandao Yuan M.D.

MD

Beijing Anzhen Hospital

研究点 (1)

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