Clinical trial NCT02215317: Sleep and Stent Study: a Multicentre, Prospective Study
Official title: Impact of Obstructive Sleep Apnea on Cardiovascular Outcomes in Patients Treated With Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: Sleep Apnea
Stent
Coronary Artery Disease
Percutaneous Coronary Intervention
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2014-08-13
Enrollment: 1815
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a prospective, observational multi-national cohort study of patients undergoing PCI for coronary artery disease. Adult patients undergoing clinically indicated PCI for coronary artery disease will be enrolled in the Sleep and Stent Study.

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants with Major Adverse Cardiac and Cerebrovascular events (MACCE)
timeFrame: Two years
Secondary outcomes:
measure: Number of Participants with Adverse Events other than MACCE
timeFrame: Two years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Venesa Loh
Study officials:
affiliation: National University Heart Centre, Singapore
name: Chi-Hang Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Loo G, Koo CY, Zhang J, Li R, Sethi R, Ong TH, Tai BC, Lee CH. Impact of obstructive sleep apnea on cardiovascular outcomes in patients treated with percutaneous coronary intervention: rationale and design of the sleep and stent study. Clin Cardiol. 2014 May;37(5):261-9. doi: 10.1002/clc.22261.