Acute Myocardial Infarction, Sleep Apnea
Conditions
Keywords
acute myocardial infarction, sleep apnea, adaptive servo-ventilation
Brief summary
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
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).
Interventions
Adaptive servo-ventilation (ASV, most recent technology of AutoSetCS device, ResMed, Sydney, Australia)
Sponsors
ResMed Foundation
University Hospital Regensburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. age 18-80 years 2. first AMI (ST-elevation in ECG or acute occlusion of coronary artery) 3. Primary successful PCI achieved \<24 h after symptom onset 4. SA with an AHI \>=15 per hour recording time 5. written informed consent
Exclusion criteria
1. previous myocardial infarction 2. previous myocardial revascularization (PCI or surgical) 3. LVEF \<45% and central sleep apnea 4. indication for a surgical revascularisation 5. cardiogenic shock, mean supine blood pressure \<60mmHg or NYHA class IV 6. implanted cardiac device or other contraindications for CMR 7. known allergies or other contraindication to contrast medium (e.g. GFR\<30ml/min/1.73m²) 8. history of stroke 9. 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 10. patients on nocturnal positive airway pressure support 11. severe obstructive or restrictive airway disease 12. heart failure due to primary valve disease 13. patients awaiting heart transplantation 14. diurnal symptoms of OSA requiring immediate treatment 15. pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| myocardial salvage index, MSI | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| infarct size and left ventricular remodelling | 12 weeks | 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) | 12 weeks | To test whether ASV therapy in patients with SA early after AMI reduces B-type natriuretic peptide (NT-proBNP). |
| disease specific symptom burden | 12 weeks | To test whether ASV therapy in patients with SA early after AMIimproves disease specific symptom burden (Seattle Angina Questionnaire) |
| suppresses sleep apnea | 12 weeks | 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). |
| renal function | 12 weeks | increases renal function (Glomerular Filtration Rate, calculated using the 4vMDRD formula). |
Countries
Germany
Outcome results
None listed