Effect of Continuous Positive Airway Pressure (CPAP) for Obstructive Sleep Apnea (OSA) on Myocardial Salvage After Primary Percutaneous Coronary Intervention for Acute ST-Segment Elevation Myocardial Infarction: A Prospective, Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Myocardial salvage index
研究概览
简要总结
The aim of this randomized controlled trial to investigate the effects of CPAP treatment on myocardial salvage index and clinical outcomes at 3 months in patients with OSA and ST-Segment Elevation Myocardial Infarction (STEMI) after primary percutaneous coronary intervention (PPCI).
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
- None
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
- •18 to 80 years old
- •First-time STEMI
- •Successful PPCI (≥1 coronary artery) within 24h after symptom onset
- •Moderate to severe OSA (AHI≥15)
- •Written informed consent
排除标准
- •Prior myocardial infarction
- •Prior myocardial revascularization (PCI or CABG)
- •Cardiogenic shock (mean arterial pressure <60mmHg), severe heart failure (Killip≥3)
- •LM or multivessel disease indicated for CABG
- •History of stroke
- •Severe insomnia, chronic sleep deprivation, abnormal circadian rhythm (sleep <4h/night)
- •Severe COPD: FEV1/FVC <70% or FEV1 <50% predicted value (within 4 weeks)
- •Predominantly central sleep apnea (≥25% central events or central AHI ≥10/h)
- •Previous or current use of CPAP
- •Severe comorbidities: eg. malignancy (life expectancy <2 years)
- •Known or planned pregnancy
- •Known contraindication to CMR
- •Patients with contraindication to CPAP or who cannot tolerate it
- •Participation in other clinical trial in recent 3 months
- •Any condition that in the opinion of investigator that may jeopardize patient compliance, eg. significant memory, perceptual, or behavioral disorder, depression, severe alcohol consumption, or a history of noncompliance
研究组 & 干预措施
CPAP treatment
Continuous positive airway pressure (CPAP, AutoSet S9, ResMed, Sydney, Australia) plus standard care (according to current STEMI guidelines) for 3 months after pPCI
干预措施: Continuous positive airway pressure (Device)
Control
Standard care (according to current STEMI guidelines) for 3 months after PPCI with no intervention for OSA
结局指标
主要结局
Myocardial salvage index
时间窗: 3 months
To investigate the effects of CPAP treatment on myocardial salvage index (MSI, assessed by cardiovascular magnetic resonance imaging, CMR) at 3 months in patients with OSA and ST-Segment Elevation Myocardial Infarction (STEMI) after primary percutaneous coronary intervention (PPCI)
次要结局
未报告次要终点
研究者
Shao-Ping Nie
Director, Emergency & Critical Care Center, Professor of Medicine
Beijing Anzhen Hospital