Sleep and Stent Study: a Multicentre, Prospective Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Chi-Hang Lee, National University, Singapore
ClinicalTrials.gov Identifier:
NCT02215317
First received: August 8, 2014
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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
Obstructive Sleep Apnea

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Obstructive Sleep Apnea on Cardiovascular Outcomes in Patients Treated With Percutaneous Coronary Intervention

Resource links provided by NLM:


Further study details as provided by National University, Singapore:

Primary Outcome Measures:
  • Number of Participants with Major Adverse Cardiac and Cerebrovascular events (MACCE) [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Cardiovascular Death, Myocardial Infarction, Stroke/TIA, Unplanned revascularization


Secondary Outcome Measures:
  • Number of Participants with Adverse Events other than MACCE [ Time Frame: Two years ] [ Designated as safety issue: No ]
    All-cause mortality, Target vessel revascularization, Stent thrombosis, Hospitalization for heart failure.


Enrollment: 1815
Study Start Date: December 2011
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02215317

Locations
Singapore
Venesa Loh
Singapore, Singapore, 119228
Sponsors and Collaborators
National University, Singapore
Boston Scientific Corporation
Investigators
Principal Investigator: Chi-Hang Lee, MD National University Heart Centre, Singapore
  More Information

Publications:
Responsible Party: Chi-Hang Lee, Associate Professor, National University, Singapore
ClinicalTrials.gov Identifier: NCT02215317     History of Changes
Other Study ID Numbers: SSS
Study First Received: August 8, 2014
Last Updated: August 11, 2014
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National University, Singapore:
Sleep Apnea
Stent
Coronary Artery Disease
Percutaneous Coronary Intervention

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on October 19, 2014