Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Acute Myocardial Infarction
  • Sleep Apnea
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

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,...

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).

Tracking Information

NCT #
NCT02093377
Collaborators
ResMed Foundation
Investigators
Principal Investigator: Michael Arzt, MD University Hospital Regensburg