Impact of Continuous Positive Airway Pressure Therapy on Outcomes in Patients Undergoing Coronary Revascularization
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
- 否
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
CPAP vs. no-CPAP in patients undergoing Coronary Revascularization follow-up for 3 years
CPAP
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
Xiandao Yuan M.D.
MD
Beijing Anzhen Hospital
