Impact of Obstructive Sleep Apnea on Cardiovascular Outcomes in Patients Treated With Percutaneous Coronary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,815
- 试验地点
- 1
- 主要终点
- Number of Participants with Major Adverse Cardiac and Cerebrovascular events (MACCE)
研究概览
简要总结
Elucidating the effects of obstructive sleep apnea (OSA) on cardiovascular outcomes is crucial in risk assessments and therapeutic recommendations for affected individuals. The Sleep and Stent Study is a multi-center observational study investigating the relationships between OSA and cardiovascular outcomes in patients treated with percutaneous coronary intervention (PCI).
详细描述
Preliminary data suggest that OSA may lead to adverse cardiovascular outcomes after PCI. However, existing data were generated from small-scale, single-center studies. Therefore, in the Sleep and Stent Study, the investigators aim to conduct a large-scale multi-national cohort study to determine the association between OSA and the incidence of adverse cardiovascular outcomes over a long-term follow-up period. The investigators hypothesize that OSA is an independent risk factor for the development of major adverse cardiovascular and cerebrovascular events (MACCEs) in coronary artery disease patients treated with PCI. Results from the Sleep and Stent Study will advance the fundamental understanding of the burden and prognostic implications of OSA in patients undergoing PCI for coronary artery disease.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old and < 80 years old
- •Successful PCI to at least one of the epicardial coronary arteries
排除标准
- •Known OSA on CPAP treatment
- •Intubation for mechanical ventilation
- •Intra-aortic balloon pump or other hemodynamic support device
- •Sedation or other muscle relaxant given before overnight sleep study
- •Perceived high risk of malignant ventricular arrhythmia
- •Cardiogenic shock with systolic blood pressure <90 mmHg
- •Clinical heart failure requiring oxygen supplementation
- •Pregnancy
- •History of malignancy (except non-melanoma skin cancer, cervical in-situ carcinoma, breast ductal carcinoma in situ or stage 1 prostate carcinoma)
结局指标
主要结局
Number of Participants with Major Adverse Cardiac and Cerebrovascular events (MACCE)
时间窗: Two years
Cardiovascular Death, Myocardial Infarction, Stroke/TIA, Unplanned revascularization
次要结局
- Number of Participants with Adverse Events other than MACCE(Two years)
研究者
Chi-Hang Lee
Associate Professor
National University of Singapore