Sleep and Stent Study: a Multicentre, Prospective Study

Completed

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT02215317
• Lead Sponsor: National University of Singapore

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2014-08-08
• Study First Submitted QC: 2014-08-11
• Study First Posted: 2014-08-13
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1815

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants with Major Adverse Cardiac and Cerebrovascular events (MACCE)	Two years	Cardiovascular Death, Myocardial Infarction, Stroke/TIA, Unplanned revascularization

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events other than MACCE	Two years	All-cause mortality, Target vessel revascularization, Stent thrombosis, Hospitalization for heart failure.

Trial Locations

Locations (1)

Venesa Loh; 🇸🇬 Singapore, Singapore