Clinical trial NCT02093377: ASV for Sleep Apnea After Myocardial Infarction
Official title: Treatment of Sleep Apnea Early After Myocardial Infarction With Adaptive Servo-Ventilation - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Myocardial Infarction
Sleep Apnea
Keywords: acute myocardial infarction
sleep apnea
adaptive servo-ventilation
Lead sponsor: University Hospital Regensburg
Sponsor class: OTHER
Collaborators: name: ResMed Foundation
First posted: 2014-03-21
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: myocardial salvage index, MSI
timeFrame: 12 weeks
Secondary outcomes:
measure: infarct size and left ventricular remodelling
timeFrame: 12 weeks
measure: B-type natriuretic peptide (NT-proBNP)
timeFrame: 12 weeks
measure: disease specific symptom burden
timeFrame: 12 weeks
measure: suppresses sleep apnea
timeFrame: 12 weeks
measure: renal function
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg
city: Regensburg
country: Germany
facility: University Hospital Regensburg
Study officials:
affiliation: University Hospital Regensburg
name: Michael Arzt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Summerer V, Arzt M, Fox H, Oldenburg O, Zeman F, Debl K, Buchner S, Stadler S. Occurrence of Coronary Collaterals in Acute Myocardial Infarction and Sleep Apnea. J Am Heart Assoc. 2021 Aug 3;10(15):e020340. doi: 10.1161/JAHA.120.020340. Epub 2021 Jul 30.
citation: Fox H, Hetzenecker A, Stadler S, Oldenburg O, Hamer OW, Zeman F, Bruch L, Seidel M, Buchner S, Arzt M; TEAM-ASV I Investigators. Rationale and design of the randomised Treatment of sleep apnoea Early After Myocardial infarction with Adaptive Servo-Ventilation trial (TEAM-ASV I). Trials. 2020 Jan 31;21(1):129. doi: 10.1186/s13063-020-4091-z.