Sleep and Stent Study: a Multicentre, Prospective Study

February 22, 2017 updated by: Chi-Hang Lee, National University, Singapore

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

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).

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1815

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 119228
        • Venesa Loh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University, Singapore

Collaborators

Boston Scientific Corporation

Investigators

  • Principal Investigator: Chi-Hang Lee, MD, National University Heart Centre, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

August 8, 2014

First Submitted That Met QC Criteria

August 11, 2014

First Posted (Estimate)

August 13, 2014

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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