ASV for Sleep Apnea After Myocardial Infarction

Study Overview
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Brief Summary
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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).

Detailed Description
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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) To test whether ASV therapy in patients with SA early after AMIimproves disease specific symptom burden (Seattle Angina Questionnaire) To test whether ASV therapy in patients with sleep apnea early after AMI suppresses sleep apnea (apneas and hypopneas/hour of sleep, mean oxygen saturation). To test whether ASV therapy in patients with sleep apnea early after AMI increases renal function (Glomerular Filtration Rate, calculated using the 4vMDRD formula).

Official Title
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Treatment of Sleep Apnea Early After Myocardial Infarction With Adaptive Servo-Ventilation - a Randomized Controlled Trial

Conditions
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Acute Myocardial Infarction, Sleep Apnea

Intervention / Treatment
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* Device: Adaptive servo-ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion criteria: 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 pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>optimal medical therapy for the management of myocardial infarction according to the current guidelines of the European Society of Cardiology alone | |
| Active Comparator: Adaptive servo-ventilation<br>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. | Device: Adaptive servo-ventilation<br>* Adaptive servo-ventilation (ASV, most recent technology of AutoSetCS device, ResMed, Sydney, Australia)<br>* Other names: ASV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infarct size and left ventricular remodelling | 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). | 12 weeks | 
| B-type natriuretic peptide (NT-proBNP) | To test whether ASV therapy in patients with SA early after AMI reduces B-type natriuretic peptide (NT-proBNP). | 12 weeks | 
| disease specific symptom burden | To test whether ASV therapy in patients with SA early after AMIimproves disease specific symptom burden (Seattle Angina Questionnaire) | 12 weeks | 
| suppresses sleep apnea | To test whether ASV therapy in patients with sleep apnea early after AMI suppresses sleep apnea (apneas and hypopneas/hour of sleep, mean oxygen saturation). | 12 weeks | 
| renal function | increases renal function (Glomerular Filtration Rate, calculated using the 4vMDRD formula). | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute myocardial infarction, sleep apnea, adaptive servo-ventilation