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Acute Myocardial InfarctionTEAM-ASV-INCT02093377

ASV for Sleep Apnea After Myocardial Infarction

A study testing Adaptive servo-ventilation in people with Acute Myocardial Infarction and Sleep Apnea, run by University Hospital Regensburg at 5 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Myocardial Infarction, Sleep Apnea
What is being tested?
Adaptive servo-ventilation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
5 sitesGermany
Study dates
Feb 2014to Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites

  • Universitätsklinikum Aachen

    Aachen, 52074

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen, 32545

  • Unfallkrankenhaus Berlin

    Berlin, 12683

  • Klinikum Oldenburg

    Oldenburg, 26133

  • University Hospital Regensburg

    Regensburg, 93053

Other trials in Germany

About this study

Official title: Treatment of Sleep Apnea Early After Myocardial Infarction With Adaptive Servo-Ventilation - a Randomized Controlled Trial

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).

Read the 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).
Being tested
Adaptive servo-ventilation
Keywords
acute myocardial infarction, sleep apnea, adaptive servo-ventilation
Medical subject headings
Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adaptive servo-ventilationDevice

    Also called ASV

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

Study groups in NCT02093377
Study groupRoleWhat they receive
ControlNo interventionoptimal medical therapy for the management of myocardial infarction according to the current guidelines of the European Society of Cardiology alone
Adaptive servo-ventilationActive comparatoroptimal 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.
Receives: Device: Adaptive servo-ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 12 weeks

Secondary outcomes (5)

  1. 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).

    Measured: 12 weeks

  2. 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).

    Measured: 12 weeks

  3. disease specific symptom burden

    To test whether ASV therapy in patients with SA early after AMIimproves disease specific symptom burden (Seattle Angina Questionnaire)

    Measured: 12 weeks

  4. 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).

    Measured: 12 weeks

  5. renal function

    increases renal function (Glomerular Filtration Rate, calculated using the 4vMDRD formula).

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionJun 2021
  4. Study completionJun 2021

Why it stopped: Throughout the COVID-19 pandemic no patient could be recruited. Patients refuse to visit the hospital for study visits.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02093377
Sponsor's protocol ID
Protocol Version 6.0
Acronym
TEAM-ASV-I
Status last verified
Sep 2021
First submitted
18 Mar 2014
Last updated
21 Sep 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 41504368

  • 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.

    PubMed 40479758

  • 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.

    PubMed 34325518

  • 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.

    PubMed 32005277

Questions about this trial

What is this clinical trial studying?

A study testing Adaptive servo-ventilation in people with Acute Myocardial Infarction and Sleep Apnea, run by University Hospital Regensburg at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Throughout the COVID-19 pandemic no patient could be recruited. Patients refuse to visit the hospital for study visits.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

myocardial salvage index, MSI (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02093377, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.

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