Sleep and Stent Study: a Multicentre, Prospective Study
This trial has been completed.
|Condition||obstructive sleep apnea|
|Sponsor||National University, Singapore|
|Collaborator||Boston Scientific Corporation|
|Start date||December 2011|
|End date||September 2015|
|Trial size||1815 participants|
|Trial identifier||NCT02215317, SSS|
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).
Patients found to have OSA based on an overnight sleep study
Patients found not to have OSA based on an overnight sleep study
Number of Participants with Major Adverse Cardiac and Cerebrovascular events (MACCE)
time frame: Two years
Number of Participants with Adverse Events other than MACCE
time frame: Two years
All participants from 18 years up to 80 years old.
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)
|Official title||Impact of Obstructive Sleep Apnea on Cardiovascular Outcomes in Patients Treated With Percutaneous Coronary Intervention|
|Principal investigator||Chi-Hang Lee, MD|
|Description||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.|
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