Treatment of Sleep Apnea Early After Myocardial Infarction With Adaptive Servo-Ventilation - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 79
- 试验地点
- 5
- 主要终点
- myocardial salvage index, MSI
研究概览
简要总结
The aim of this randomized controlled trial is to test the effect of 12 weeks Adaptive Servo-Ventilation (ASV) therapy (additionally to optimal medical management of myocardial infarction) on myocardial salvage (MSI=myocardial salvage/area at risk, primary endpoint).
详细描述
Primary Outcome Measure: myocardial salvage index, MSI
- To test the effect of 12 weeks of ASV (additionally to percutaneous coronary intervention, PCI, and optimal medical management of AMI) on myocardial salvage (myocardial salvage index, MSI, assessed by cardiovascular magnetic resonance imaging, CMR).
Secondary Outcome Measures:
- To test whether ASV therapy in patients with SA early after AMI decreases infarct size and improves left ventricular remodelling (myocardial salvage, microvascular obstruction change of infarct size, infarct size at 12 weeks, change of left ventricular ejection fraction (LVEF), left ventricular systolic volume (LVSV), left ventricular diastolic volume (LVDV) and LVEF at 12 weeks; assessed with CMR).
B-type natriuretic peptide (NT-proBNP)
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
- •age 18-80 years
- •first AMI (ST-elevation in ECG or acute occlusion of coronary artery)
- •Primary successful PCI achieved <24 h after symptom onset
- •SA with an AHI >=15 per hour recording time
- •written informed consent
排除标准
- •previous myocardial infarction
- •previous myocardial revascularization (PCI or surgical)
- •LVEF <45% and central sleep apnea
- •indication for a surgical revascularisation
- •cardiogenic shock, mean supine blood pressure <60mmHg or NYHA class IV
- •implanted cardiac device or other contraindications for CMR
- •known allergies or other contraindication to contrast medium (e.g. GFR<30ml/min/1.73m²)
- •history of stroke
- •contraindications for positive airway pressure support (hypotension with mean supine BP <60mmHg, dehydration, inability to clear secretions, patients at risk for aspiration of gastric contents, severe bullous lung disease, history of pneumothorax and/or pneumomediastinum, a history of epistaxis, causing pulmonary aspiration of blood, cerebrospinal fluid leak or recent skull operations or injury) patients on or with indication for oxygen therapy, mechanical/non-invasive ventilation
- •patients on nocturnal positive airway pressure support
- •severe obstructive or restrictive airway disease
- •heart failure due to primary valve disease
- •patients awaiting heart transplantation
- •diurnal symptoms of OSA requiring immediate treatment
研究组 & 干预措施
Control
optimal medical therapy for the management of myocardial infarction according to the current guidelines of the European Society of Cardiology alone
Adaptive servo-ventilation
optimal medical therapy for the management of myocardial infarction according to the current guidelines of the European Society of Cardiology plus treatment of sleep apnea with adaptive servo-ventilation (ASV, most recent technology of AutoSetCS device, ResMed, Sydney, Australia). Dose: The optimal ASV settings will be determined during 1-2 nights monitored by polygraphy within 5 days after PCI.
干预措施: Adaptive servo-ventilation (Device)
结局指标
主要结局
myocardial salvage index, MSI
时间窗: 12 weeks
To test the effect of 12 weeks of ASV (additionally to percutaneous coronary intervention, PCI, and optimal medical management of AMI) on myocardial salvage (myocardial salvage index, MSI, assessed by cardiovascular magnetic resonance imaging, CMR).
次要结局
- renal function(12 weeks)
- disease specific symptom burden(12 weeks)
- B-type natriuretic peptide (NT-proBNP)(12 weeks)
- infarct size and left ventricular remodelling(12 weeks)
- suppresses sleep apnea(12 weeks)
研究者
Michael Arzt
Principal Investigator
University Hospital Regensburg