ASV for Sleep Apnea After Myocardial Infarction (TEAM-ASV-I)

University Hospital Regensburg

Status: Terminated

Conditions: Sleep Apnea; Acute Myocardial Infarction

Treatments: Device: Adaptive servo-ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT02093377

Protocol Version 6.0

Details and patient eligibility

About

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).

Full 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).

Enrollment: 79 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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79 participants in 2 patient groups

Control

No Intervention group

Description:

optimal medical therapy for the management of myocardial infarction according to the current guidelines of the European Society of Cardiology alone

Adaptive servo-ventilation

Active Comparator group

Description:

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.

Treatment:

Device: Adaptive servo-ventilation