OSA-ACS Project: Association of OSA and CPAP Therapy With Outcomes in ACS Patients

Study Overview
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Brief Summary
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Obstructive sleep apnea (OSA) is an increasingly common chronic disorder in adults that has been strongly associated with various forms of cardiovascular disease. Compared to the general population, OSA occurs more often in patients with acute coronary syndrome (ACS). Although percutaneous coronary intervention (PCI) is nowadays part of standard therapy and optimal medical therapy has been used to manage traditional risk factors, the long-term cardiovascular outcomes after index ACS remain suboptimal. Some preliminary data suggest OSA is associated with higher risk of subsequent cardiovascular events in ACS patients. However, the study population was heterogeneous and these studies were not done in the context of new-generation drug-eluting stents and intensive antiplatelet therapy, thus precluding definite conclusions. Furthermore, a cardioprotective role of OSA in the context of acute myocardial infarction (AMI), via ischemic preconditioning, has also been postulated. Due to the inconsistent evidence, the investigators performed a large-scale, prospective cohort study to delineate the whole picture of the association of OSA with short- and long-term outcomes of patients with ACS. Whether treatment of OSA (eg. continuous positive airway pressure (CPAP)) would prevent these events will also be evaluated. Moreover, the investigators will assess the potential mechanisms of OSA-induced atherosclerosis and myocardial injury in ACS patients.

Official Title
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Impact of Obstructive Sleep Apnea and Continuous Positive Airway Pressure Therapy on Outcomes in Patients With Acute Coronary Syndrome: The OSA-ACS Project

Conditions
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Obstructive Sleep Apnea of Adult, Acute Coronary Syndrome

Intervention / Treatment
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* Other: Patients with OSA based on sleep study
* Other: Patients without OSA based on sleep study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years old Admission with an ACS (including STEMI, NSTEMI, and unstable angina) Written informed consent Exclusion Criteria: Cardiogenic shock (systolic blood pressure <90mmHg) Cardiac arrest on admission or during hospitalization Severe insomnia, chronic sleep deprivation, abnormal circadian rhythm (sleep duration <4h/night) Predominantly central sleep apnea (CSA, ≥50% central events or central apnea hypopnea index (AHI) ≥10/h) Previous or current use of CPAP Known or planned pregnancy Severe comorbidities: eg. malignancy (life expectancy <2 years) Patients who cannot tolerate the sleep study or refuse it

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OSA<br> | Other: Patients with OSA based on sleep study<br>* Polysomnography or Polygraphy<br>|
| Non-OSA<br> | Other: Patients without OSA based on sleep study<br>* Polysomnography or Polygraphy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac and cerebrovascular events (MACCEs) | Including cardiovascular death, myocardial infarction, stroke, ischemia-driven revascularization, and hospitalization for unstable angina or heart failure | Median 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular death |  | Median 24 months | 
| All-cause mortality |  | Median 24 months | 
| Hospitalization for unstable angina |  | Median 24 months | 
| Ischemia-driven revascularization |  | Median 24 months | 
| Any repeat revascularization |  | Median 24 months | 
| Myocardial salvage index (assessed by CMR) |  | 3 months | 
| Relative proliferation volume within stent segment (% of stent volume) |  | 12 months | 
| MACCEs | Effect of continuous positive airway pressure (CPAP) treatment on MACCEs in patients with OSA and ACS | Median 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive sleep apnea, Acute coronary syndrome, Continuous positive airway pressure, Outcome