Sleep and Stent Study: a Multicentre, Prospective Study
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).
Obstructive Sleep Apnea
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Impact of Obstructive Sleep Apnea on Cardiovascular Outcomes in Patients Treated With Percutaneous Coronary Intervention|
- Number of Participants with Major Adverse Cardiac and Cerebrovascular events (MACCE) [ Time Frame: Two years ] [ Designated as safety issue: No ]Cardiovascular Death, Myocardial Infarction, Stroke/TIA, Unplanned revascularization
- Number of Participants with Adverse Events other than MACCE [ Time Frame: Two years ] [ Designated as safety issue: No ]All-cause mortality, Target vessel revascularization, Stent thrombosis, Hospitalization for heart failure.
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||July 2019|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Patients found to have OSA based on an overnight sleep study
Patients found not to have OSA based on an overnight sleep study
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02215317
|Singapore, Singapore, 119228|
|Principal Investigator:||Chi-Hang Lee, MD||National University Heart Centre, Singapore|