ASV for Sleep Apnea After Myocardial Infarction

Not Applicable

Terminated

• Conditions: Sleep Apnea; Acute Myocardial Infarction
• Interventions: Device: Adaptive servo-ventilation

• Registration Number: NCT02093377
• Lead Sponsor: University Hospital Regensburg

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).

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-20
• Study First Posted: 2014-03-21
• Primary Completion: 2021-06
• Study Completion: 2021-06
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-14
• Last Update Posted: 2021-09-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 79

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adaptive servo-ventilation	Adaptive servo-ventilation	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
renal function	12 weeks	increases renal function (Glomerular Filtration Rate, calculated using the 4vMDRD formula).
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)
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).
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).
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).

Trial Locations

Locations (5)

Klinikum Oldenburg; 🇩🇪 Oldenburg, Germany

Herz- und Diabeteszentrum NRW; 🇩🇪 Bad Oeynhausen, Germany

University Hospital Regensburg; 🇩🇪 Regensburg, Germany

Unfallkrankenhaus Berlin; 🇩🇪 Berlin, Germany

Universitätsklinikum Aachen; 🇩🇪 Aachen, Germany