ASV for Sleep Apnea After Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

— TEAM-ASV-I  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02093377
• Other study ID #: Protocol Version 6.0
• Status: Terminated
• Phase: N/A
• Start date: February 2014
• Est. completion date: June 2021

Study information

• Verified date: September 2021
• Source: University Hospital Regensburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 79
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Apnea
• Infarction
• Myocardial Infarction
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

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

Locations

Country	Name	City	State
Germany	Universitätsklinikum Aachen	Aachen
Germany	Herz- und Diabeteszentrum NRW	Bad Oeynhausen
Germany	Unfallkrankenhaus Berlin	Berlin
Germany	Klinikum Oldenburg	Oldenburg
Germany	University Hospital Regensburg	Regensburg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Regensburg	ResMed Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	renal function	increases renal function (Glomerular Filtration Rate, calculated using the 4vMDRD formula).	12 weeks