TEAM-ASV-I: ASV for Sleep Apnea After Myocardial Infarction

• Sponsor: University Hospital Regensburg (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02093377
• Collaborator: ResMed Foundation (Other)
• Enrollment: 79
• Locations: 5
• Arms: 2
• Duration (Months): 88
• Patients Per Site: 15.8
• Patients Per Site Per Month: 0.2

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Acute Myocardial Infarction; Sleep Apnea	Device: Adaptive servo-ventilation	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 79 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment of Sleep Apnea Early After Myocardial Infarction With Adaptive Servo-Ventilation - a Randomized Controlled Trial
• Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Jun 1, 2021
• Actual Study Completion Date: Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control optimal medical therapy for the management of myocardial infarction according to the current guidelines of the European Society of Cardiology alone
Active Comparator: Adaptive servo-ventilation 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; Adaptive servo-ventilation (ASV, most recent technology of AutoSetCS device, ResMed, Sydney, Australia); Other Names: ASV

Outcome Measures

Primary Outcome Measures

1. myocardial salvage index, MSI [12 weeks]

   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

1. infarct size and left ventricular remodelling [12 weeks]

   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).

2. B-type natriuretic peptide (NT-proBNP) [12 weeks]

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

3. disease specific symptom burden [12 weeks]

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

4. suppresses sleep apnea [12 weeks]

   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).

5. renal function [12 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. age 18-80 years

2. first AMI (ST-elevation in ECG or acute occlusion of coronary artery)

3. Primary successful PCI achieved <24 h after symptom onset

4. SA with an AHI >=15 per hour recording time

5. written informed consent

Exclusion criteria:

1. previous myocardial infarction

2. previous myocardial revascularization (PCI or surgical)

3. LVEF <45% and central sleep apnea

4. indication for a surgical revascularisation

5. cardiogenic shock, mean supine blood pressure <60mmHg or NYHA class IV

6. implanted cardiac device or other contraindications for CMR

7. known allergies or other contraindication to contrast medium (e.g. GFR<30ml/min/1.73m²)

8. history of stroke

9. 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

10. patients on nocturnal positive airway pressure support

11. severe obstructive or restrictive airway disease

12. heart failure due to primary valve disease

13. patients awaiting heart transplantation

14. diurnal symptoms of OSA requiring immediate treatment

15. pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinikum Aachen	Aachen		Germany	52074
2	Herz- und Diabeteszentrum NRW	Bad Oeynhausen		Germany	32545
3	Unfallkrankenhaus Berlin	Berlin		Germany	12683
4	Klinikum Oldenburg	Oldenburg		Germany	26133
5	University Hospital Regensburg	Regensburg		Germany	93053

Sponsors and Collaborators

• University Hospital Regensburg
• ResMed Foundation

Investigators

• Principal Investigator: Michael Arzt, MD, University Hospital Regensburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Arzt, Principal Investigator, University Hospital Regensburg
• ClinicalTrials.gov Identifier: NCT02093377
• Other Study ID Numbers: Protocol Version 6.0
• First Posted: Mar 21, 2014
• Last Update Posted: Sep 21, 2021
• Last Verified: Sep 1, 2021

• Keywords provided by Michael Arzt, Principal Investigator, University Hospital Regensburg: acute myocardial infarction; sleep apnea; adaptive servo-ventilation
• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes; Myocardial Infarction; Infarction

Study Results

No Results Posted as of Sep 21, 2021