ASV for Sleep Apnea After Myocardial Infarction

  • STATUS
    Recruiting
  • End date
    Dec 25, 2021
  • participants needed
    90
  • sponsor
    University Hospital Regensburg
Updated on 25 January 2021
electrocardiogram
myocardial infarction
adaptive servo-ventilation

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).

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).

Details
Condition Sleep apnea, Acute Myocardial Infarction, Sleep Apnea Syndromes
Treatment Adaptive Servo-Ventilation
Clinical Study IdentifierNCT02093377
SponsorUniversity Hospital Regensburg
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have any of these conditions: Sleep apnea or Sleep Apnea Syndromes or Acute Myocardial Infarction?
Do you have any of these conditions: Sleep Apnea Syndromes or Acute Myocardial Infarction or Sleep apnea?
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/1.73m)
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
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