Sleep and Stent Study: a Multicentre, Prospective Study

Impact of Obstructive Sleep Apnea on Cardiovascular Outcomes in Patients Treated With Percutaneous Coronary Intervention

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02215317

Enrollment

1815

Registered

2014-08-13

Start date

2011-12-31

Completion date

2015-09-30

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

Sleep Apnea, Stent, Coronary Artery Disease, Percutaneous Coronary Intervention

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

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

Countries

Singapore

Outcome results