CPAP for OSA on Myocardial Salvage After pPCI for STEMI Patients

Study Overview
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Brief Summary
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The aim of this randomized controlled trial to investigate the effects of CPAP treatment on myocardial salvage index and clinical outcomes at 3 months in patients with OSA and ST-Segment Elevation Myocardial Infarction (STEMI) after primary percutaneous coronary intervention (PPCI).

Official Title
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Effect of Continuous Positive Airway Pressure (CPAP) for Obstructive Sleep Apnea (OSA) on Myocardial Salvage After Primary Percutaneous Coronary Intervention for Acute ST-Segment Elevation Myocardial Infarction: A Prospective, Multicenter, Randomized Controlled Trial

Conditions
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Obstructive Sleep Apnea, ST Elevation Myocardial Infarction

Intervention / Treatment
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* Device: Continuous positive airway pressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 80 years old First-time STEMI Successful PPCI (≥1 coronary artery) within 24h after symptom onset Moderate to severe OSA (AHI≥15) Written informed consent Exclusion Criteria: Prior myocardial infarction Prior myocardial revascularization (PCI or CABG) Cardiogenic shock (mean arterial pressure <60mmHg), severe heart failure (Killip≥3) LM or multivessel disease indicated for CABG History of stroke Severe insomnia, chronic sleep deprivation, abnormal circadian rhythm (sleep <4h/night) Severe COPD: FEV1/FVC <70% or FEV1 <50% predicted value (within 4 weeks) Predominantly central sleep apnea (≥25% central events or central AHI ≥10/h) Previous or current use of CPAP Severe comorbidities: eg. malignancy (life expectancy <2 years) Known or planned pregnancy Known contraindication to CMR Patients with contraindication to CPAP or who cannot tolerate it Participation in other clinical trial in recent 3 months Any condition that in the opinion of investigator that may jeopardize patient compliance, eg. significant memory, perceptual, or behavioral disorder, depression, severe alcohol consumption, or a history of noncompliance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP treatment<br>Continuous positive airway pressure (CPAP, AutoSet S9, ResMed, Sydney, Australia) plus standard care (according to current STEMI guidelines) for 3 months after pPCI | Device: Continuous positive airway pressure<br>* The optimal continuous positive airway pressure (CPAP, AutoSet S9, ResMed, Sydney, Australia) settings will be determined during 1-2 nights within 7 days after pPCI.<br>* Other names: CPAP;|
| No Intervention: Control<br>Standard care (according to current STEMI guidelines) for 3 months after PPCI with no intervention for OSA | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial salvage index | To investigate the effects of CPAP treatment on myocardial salvage index (MSI, assessed by cardiovascular magnetic resonance imaging, CMR) at 3 months in patients with OSA and ST-Segment Elevation Myocardial Infarction (STEMI) after primary percutaneous coronary intervention (PPCI) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous Positive Airway Pressure, Myocardial Salvage, Obstructive Sleep Apnea, ST Elevation Myocardial Infarction