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Sleep and Stent Study: a Multicentre, Prospective Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02215317
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : February 23, 2017
Boston Scientific Corporation
Information provided by (Responsible Party):
Chi-Hang Lee, National University, 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).

Condition or disease
Obstructive Sleep Apnea

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.

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Study Type : Observational
Actual Enrollment : 1815 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Obstructive Sleep Apnea on Cardiovascular Outcomes in Patients Treated With Percutaneous Coronary Intervention
Study Start Date : December 2011
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

OSA group
Patients found to have OSA based on an overnight sleep study
Non-OSA group
Patients found not to have OSA based on an overnight sleep study

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02215317

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Venesa Loh
Singapore, Singapore, 119228
Sponsors and Collaborators
National University, Singapore
Boston Scientific Corporation
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Principal Investigator: Chi-Hang Lee, MD National University Heart Centre, Singapore
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Responsible Party: Chi-Hang Lee, Associate Professor, National University, Singapore Identifier: NCT02215317    
Other Study ID Numbers: SSS
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Keywords provided by Chi-Hang Lee, National University, Singapore:
Sleep Apnea
Coronary Artery Disease
Percutaneous Coronary Intervention
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases