ASV for Sleep Apnea After Myocardial Infarction

N/ATerminatedNCT02093377

University Hospital Regensburg79 enrolled

Overview

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).

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Myocardial Infarction Sleep Apnea

Interventions

Adaptive servo-ventilationDEVICE

Adaptive servo-ventilation (ASV, most recent technology of AutoSetCS device, ResMed, Sydney, Australia)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (5)

Universitätsklinikum Aachen

Aachen, Germany

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, Germany

Unfallkrankenhaus Berlin

Berlin, Germany

Klinikum Oldenburg

Oldenburg, Germany

University Hospital Regensburg

Outcomes

Primary Outcomes

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).

Time frame: 12 weeks

Secondary Outcomes

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).

Time frame: 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).

Time frame: 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)

Time frame: 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).

Time frame: 12 weeks

renal function

increases renal function (Glomerular Filtration Rate, calculated using the 4vMDRD formula).

Time frame: 12 weeks

Data from ClinicalTrials.gov

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