Overview

This trial is active, not recruiting.

Condition obstructive sleep apnea
Sponsor National University, Singapore
Collaborator Boston Scientific Corporation
Start date December 2011
End date September 2018
Trial size 1815 participants
Trial identifier NCT02215317, SSS

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients found to have OSA based on an overnight sleep study
Patients found not to have OSA based on an overnight sleep study

Primary Outcomes

Measure
Number of Participants with Major Adverse Cardiac and Cerebrovascular events (MACCE)
time frame: Two years

Secondary Outcomes

Measure
Number of Participants with Adverse Events other than MACCE
time frame: Two years

Eligibility Criteria

Male or female 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)

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by National University, Singapore.