Impact of Obstructive Sleep Apnea and Continuous Positive Airway Pressure Therapy on Outcomes in Patients With Acute Coronary Syndrome: The OSA-ACS Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,160
- 试验地点
- 1
- 主要终点
- Major adverse cardiac and cerebrovascular events (MACCEs)
研究概览
简要总结
Obstructive sleep apnea (OSA) is an increasingly common chronic disorder in adults that has been strongly associated with various forms of cardiovascular disease. Compared to the general population, OSA occurs more often in patients with acute coronary syndrome (ACS). Although percutaneous coronary intervention (PCI) is nowadays part of standard therapy and optimal medical therapy has been used to manage traditional risk factors, the long-term cardiovascular outcomes after index ACS remain suboptimal.
Some preliminary data suggest OSA is associated with higher risk of subsequent cardiovascular events in ACS patients. However, the study population was heterogeneous and these studies were not done in the context of new-generation drug-eluting stents and intensive antiplatelet therapy, thus precluding definite conclusions. Furthermore, a cardioprotective role of OSA in the context of acute myocardial infarction (AMI), via ischemic preconditioning, has also been postulated.
Due to the inconsistent evidence, the investigators performed a large-scale, prospective cohort study to delineate the whole picture of the association of OSA with short- and long-term outcomes of patients with ACS. Whether treatment of OSA (eg. continuous positive airway pressure (CPAP)) would prevent these events will also be evaluated. Moreover, the investigators will assess the potential mechanisms of OSA-induced atherosclerosis and myocardial injury in ACS patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old
- •Admission with an ACS (including STEMI, NSTEMI, and unstable angina)
- •Written informed consent
排除标准
- •Cardiogenic shock (systolic blood pressure <90mmHg)
- •Cardiac arrest on admission or during hospitalization
- •Severe insomnia, chronic sleep deprivation, abnormal circadian rhythm (sleep duration <4h/night)
- •Predominantly central sleep apnea (CSA, ≥50% central events or central apnea hypopnea index (AHI) ≥10/h)
- •Previous or current use of CPAP
- •Known or planned pregnancy
- •Severe comorbidities: eg. malignancy (life expectancy <2 years)
- •Patients who cannot tolerate the sleep study or refuse it
结局指标
主要结局
Major adverse cardiac and cerebrovascular events (MACCEs)
时间窗: Median 24 months
Including cardiovascular death, myocardial infarction, stroke, ischemia-driven revascularization, and hospitalization for unstable angina or heart failure
次要结局
- Cardiovascular death(Median 24 months)
- Hospitalization for unstable angina(Median 24 months)
- Any repeat revascularization(Median 24 months)
- Relative proliferation volume within stent segment (% of stent volume)(12 months)
- All-cause mortality(Median 24 months)
- Myocardial salvage index (assessed by CMR)(3 months)
- Ischemia-driven revascularization(Median 24 months)
- MACCEs(Median 24 months)
研究者
Shao-Ping Nie
Director, Emergency & Critical Care Center, Professor of Medicine
Beijing Anzhen Hospital