Sleep and Stent Study: a Multicentre, Prospective Study

Study Overview
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Brief Summary
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Elucidating the effects of obstructive sleep apnea (OSA) on cardiovascular outcomes is crucial in risk assessments and therapeutic recommendations for affected individuals. The Sleep and Stent Study is a multi-center observational study investigating the relationships between OSA and cardiovascular outcomes in patients treated with percutaneous coronary intervention (PCI).

Detailed Description
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Preliminary data suggest that OSA may lead to adverse cardiovascular outcomes after PCI. However, existing data were generated from small-scale, single-center studies. Therefore, in the Sleep and Stent Study, the investigators aim to conduct a large-scale multi-national cohort study to determine the association between OSA and the incidence of adverse cardiovascular outcomes over a long-term follow-up period. The investigators hypothesize that OSA is an independent risk factor for the development of major adverse cardiovascular and cerebrovascular events (MACCEs) in coronary artery disease patients treated with PCI. Results from the Sleep and Stent Study will advance the fundamental understanding of the burden and prognostic implications of OSA in patients undergoing PCI for coronary artery disease.

Official Title
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Impact of Obstructive Sleep Apnea on Cardiovascular Outcomes in Patients Treated With Percutaneous Coronary Intervention

Conditions
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Obstructive Sleep Apnea

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years old and < 80 years old Successful PCI to at least one of the epicardial coronary arteries Exclusion Criteria: Known OSA on CPAP treatment Intubation for mechanical ventilation Intra-aortic balloon pump or other hemodynamic support device Sedation or other muscle relaxant given before overnight sleep study Perceived high risk of malignant ventricular arrhythmia Cardiogenic shock with systolic blood pressure <90 mmHg Clinical heart failure requiring oxygen supplementation Pregnancy History of malignancy (except non-melanoma skin cancer, cervical in-situ carcinoma, breast ductal carcinoma in situ or stage 1 prostate carcinoma)

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OSA group<br>Patients found to have OSA based on an overnight sleep study | |
| Non-OSA group<br>Patients found not to have OSA based on an overnight sleep study | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Major Adverse Cardiac and Cerebrovascular events (MACCE) | Cardiovascular Death, Myocardial Infarction, Stroke/TIA, Unplanned revascularization | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events other than MACCE | All-cause mortality, Target vessel revascularization, Stent thrombosis, Hospitalization for heart failure. | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Apnea, Stent, Coronary Artery Disease, Percutaneous Coronary Intervention