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Throughout the COVID-19 pandemic no patient could be recruited. Patients refuse to visit the hospital for study visits.
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| Name | Class |
|---|---|
| ResMed Foundation | OTHER |
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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).
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | 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 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptive servo-ventilation | Device | Adaptive servo-ventilation (ASV, most recent technology of AutoSetCS device, ResMed, Sydney, Australia) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| infarct size and left ventricular remodelling | 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). |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Arzt, MD | University Hospital Regensburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Aachen | Aachen | 52074 | Germany | |||
| Herz- und Diabeteszentrum NRW |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41504368 | Derived | Pec J, Baumert M, Fox H, Stadler S, Driendl S, Oldenburg O, Zeman F, Tanacli R, Kelle S, Buchner S, Arzt M. Effects of treatment with minute-ventilation triggered adaptive servo-ventilation early after acute myocardial infarction on nocturnal hypoxemic burden: results from TEAM-ASV I. Sleep. 2026 Apr 16;49(4):zsaf411. doi: 10.1093/sleep/zsaf411. | |
| 40479758 |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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|
| 12 weeks |
| B-type natriuretic peptide (NT-proBNP) | To test whether ASV therapy in patients with SA early after AMI reduces B-type natriuretic peptide (NT-proBNP). | 12 weeks |
| disease specific symptom burden | To test whether ASV therapy in patients with SA early after AMIimproves disease specific symptom burden (Seattle Angina Questionnaire) | 12 weeks |
| suppresses sleep apnea | 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). | 12 weeks |
| renal function | increases renal function (Glomerular Filtration Rate, calculated using the 4vMDRD formula). | 12 weeks |
| Bad Oeynhausen |
| 32545 |
| Germany |
| Unfallkrankenhaus Berlin | Berlin | 12683 | Germany |
| Klinikum Oldenburg | Oldenburg | 26133 | Germany |
| University Hospital Regensburg | Regensburg | 93053 | Germany |
| Pec J, Fox H, Stadler S, Hetzenecker A, Oldenburg O, Koller M, Zeman F, Buchner S, Wagner S, Arzt M; TEAM-ASV I Investigators. Effect of adaptive servo-ventilation on circulating biomarkers in patients with sleep apnoea after myocardial infarction: results of an ancillary analysis of the randomised TEAM-ASV I trial. Sleep Med. 2025 Sep;133:106620. doi: 10.1016/j.sleep.2025.106620. Epub 2025 May 31. |
| 34325518 | Derived | 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. |
| 32005277 | Derived | 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. |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |