NCT02093377

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2014

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

7.3 years

First QC Date

March 18, 2014

Last Update Submit

September 14, 2021

Conditions

Acute Myocardial InfarctionSleep Apnea

Keywords

acute myocardial infarctionsleep apneaadaptive servo-ventilation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • infarct size and left ventricular remodelling

    12 weeks

  • B-type natriuretic peptide (NT-proBNP)

    12 weeks

  • disease specific symptom burden

    12 weeks

  • suppresses sleep apnea

    12 weeks

  • renal function

    12 weeks

Study Arms (2)

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.

Device: Adaptive servo-ventilation

Interventions

Adaptive servo-ventilationDEVICE

Adaptive servo-ventilation (ASV, most recent technology of AutoSetCS device, ResMed, Sydney, Australia)

Also known as: ASV
Adaptive servo-ventilation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18-80 years
  • first AMI (ST-elevation in ECG or acute occlusion of coronary artery)
  • Primary successful PCI achieved \<24 h after symptom onset
  • SA with an AHI \>=15 per hour recording time
  • written informed consent

You may not qualify if:

  • previous myocardial infarction
  • previous myocardial revascularization (PCI or surgical)
  • LVEF \<45% and central sleep apnea
  • indication for a surgical revascularisation
  • cardiogenic shock, mean supine blood pressure \<60mmHg or NYHA class IV
  • implanted cardiac device or other contraindications for CMR
  • known allergies or other contraindication to contrast medium (e.g. GFR\<30ml/min/1.73m²)
  • history of stroke
  • 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
  • patients on nocturnal positive airway pressure support
  • severe obstructive or restrictive airway disease
  • heart failure due to primary valve disease
  • patients awaiting heart transplantation
  • diurnal symptoms of OSA requiring immediate treatment
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Universitätsklinikum Aachen

Aachen, 52074, Germany

Location

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

Location

Unfallkrankenhaus Berlin

Berlin, 12683, Germany

Location

Klinikum Oldenburg

Oldenburg, 26133, Germany

Location

University Hospital Regensburg

Regensburg, 93053, Germany

Location

Related Publications (4)

  • 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 hypoxaemic burden: results from TEAM-ASV I. Sleep. 2026 Jan 8:zsaf411. doi: 10.1093/sleep/zsaf411. Online ahead of print.

    PMID: 41504368DERIVED

  • 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.

    PMID: 40479758DERIVED

  • 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.

    PMID: 34325518DERIVED

  • 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.

    PMID: 32005277DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Michael Arzt, MD

    University Hospital Regensburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 18, 2014

First Posted

March 21, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

September 21, 2021

Record last verified: 2021-09

Locations

DE(5)