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Completed

NCT Number: NCT02215317

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).

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Key information

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Number of Participants with Major Adverse Cardiac and Cerebrovascular events (MACCE)

    Time frame: Two years

    Cardiovascular Death, Myocardial Infarction, Stroke/TIA, Unplanned revascularization

Secondary outcomes

  1. Number of Participants with Adverse Events other than MACCE

    Time frame: Two years

    All-cause mortality, Target vessel revascularization, Stent thrombosis, Hospitalization for heart failure.

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Aug 13, 2014
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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