Rationale and design of the randomised Treatment of sleep apnoea Early After Myocardial infarction with Adaptive Servo-Ventilation trial (TEAM-ASV I)

Fox, Henrik and Hetzenecker, Andrea and Stadler, Stefan and Oldenburg, Olaf and Hamer, Okka W. and Zeman, Florian and Bruch, Leonhard and Seidel, Mirko and Buchner, Stefan and Arzt, Michael (2020) Rationale and design of the randomised Treatment of sleep apnoea Early After Myocardial infarction with Adaptive Servo-Ventilation trial (TEAM-ASV I). TRIALS, 21 (1): 129. ISSN , 1745-6215

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Abstract

Aims In acute myocardial infarction (AMI), impaired myocardial salvage and large infarct size result in residual heart failure, which is one of the most important predictors of morbidity and mortality after AMI. Sleep-disordered breathing (SDB) is associated with reduced myocardial salvage index (MSI) within the first 3 months after AMI. Adaptive servo-ventilation (ASV) can effectively treat both types of SDB (central and obstructive sleep apnoea). The Treatment of sleep apnoea Early After Myocardial infarction with Adaptive Servo-Ventilation trial (TEAM-ASV I) will investigate the effects of ASV therapy, added to percutaneous coronary intervention (PCI) and optimal medical management of AMI, on myocardial salvage after AMI. Methods/design TEAM ASV-I is a multicentre, randomised, parallel-group, open-label trial with blinded assessment of PCI outcomes. Patients with first AMI and successful PCI within 24 h after symptom onset and SDB (apnoea-hypopnoea index >= 15/h) will be randomised (1:1 ratio) to PCI and optimal medical therapy alone (control) or plus ASV (with stratification of randomisation by infarct location; left anterior descending (LAD) or no LAD lesion). The primary outcome is the MSI, assessed by cardiac magnetic resonance imaging. Key secondary outcomes are change of infarct size, left ventricular ejection fraction and B-type natriuretic peptide levels and disease-specific symptom burden at 12 weeks. Conclusion TEAM ASV-I will help to determine whether treatment of SDB with ASV in the acute phase after myocardial infarction contributes to more myocardial salvage and healing.

Item Type: Article
Uncontrolled Keywords: ST-SEGMENT ELEVATION; POSITIVE AIRWAY PRESSURE; MAGNETIC-RESONANCE; SALVAGE; IMPACT; HEART; MECHANISMS; GUIDELINES; MANAGEMENT; SOCIETY; Heart failure; Myocardial infarction; Sleep-disordered breathing; Myocardial salvage; Adaptive servo-ventilation; Cardiac magnetic resonance imaging
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Lehrstuhl für Innere Medizin II
Medicine > Lehrstuhl für Röntgendiagnostik
Medicine > Zentren des Universitätsklinikums Regensburg > Zentrum für Klinische Studien
Depositing User: Dr. Gernot Deinzer
Date Deposited: 31 Mar 2021 10:36
Last Modified: 31 Mar 2021 10:36
URI: https://pred.uni-regensburg.de/id/eprint/45294

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