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ASV for Sleep Apnea After Myocardial Infarction (TEAM-ASV-I)

Primary Purpose

Acute Myocardial Infarction, Sleep Apnea

Status

Terminated

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Adaptive servo-ventilation

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring acute myocardial infarction, sleep apnea, adaptive servo-ventilation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion criteria:

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

Sites / Locations

Universitätsklinikum Aachen
Herz- und Diabeteszentrum NRW
Unfallkrankenhaus Berlin
Klinikum Oldenburg
University Hospital Regensburg

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Adaptive servo-ventilation

Arm Description

optimal medical therapy for the management of myocardial infarction according to the current guidelines of the European Society of Cardiology alone

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.

Outcomes

Primary Outcome Measures

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

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).

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).

disease specific symptom burden

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

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).

renal function

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

Full Information

NCT ID

NCT02093377

First Posted

March 18, 2014

Last Updated

September 14, 2021

Sponsor

University Hospital Regensburg

Collaborators

ResMed Foundation

1. Study Identification

Unique Protocol Identification Number

NCT02093377

Brief Title

ASV for Sleep Apnea After Myocardial Infarction

Acronym

TEAM-ASV-I

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Terminated

Why Stopped

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

Study Start Date

February 2014 (undefined)

Primary Completion Date

June 2021 (Actual)

Study Completion Date

June 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital Regensburg

Collaborators

ResMed Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myocardial Infarction, Sleep Apnea

Keywords

acute myocardial infarction, sleep apnea, adaptive servo-ventilation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

79 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

optimal medical therapy for the management of myocardial infarction according to the current guidelines of the European Society of Cardiology alone

Arm Title

Adaptive servo-ventilation

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Adaptive servo-ventilation

Other Intervention Name(s)

ASV

Intervention Description

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

Primary Outcome Measure Information:

Title

myocardial salvage index, MSI

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

infarct size and left ventricular remodelling

Description

Time Frame

12 weeks

Title

B-type natriuretic peptide (NT-proBNP)

Description

To test whether ASV therapy in patients with SA early after AMI reduces B-type natriuretic peptide (NT-proBNP).

Time Frame

12 weeks

Title

disease specific symptom burden

Description

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

Time Frame

12 weeks

Title

suppresses sleep apnea

Description

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).

Time Frame

12 weeks

Title

renal function

Description

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

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Arzt, MD

Organizational Affiliation

University Hospital Regensburg

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universitätsklinikum Aachen

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Facility Name

Herz- und Diabeteszentrum NRW

City

Bad Oeynhausen

ZIP/Postal Code

32545

Country

Germany

Facility Name

Unfallkrankenhaus Berlin

City

Berlin

ZIP/Postal Code

12683

Country

Germany

Facility Name

Klinikum Oldenburg

City

Oldenburg

ZIP/Postal Code

26133

Country

Germany

Facility Name

University Hospital Regensburg

City

Regensburg

ZIP/Postal Code

93053

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

34325518

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.

Results Reference

derived

PubMed Identifier

32005277

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.

Results Reference

derived

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ASV for Sleep Apnea After Myocardial Infarction

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