<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02215317</url>
  </required_header>
  <id_info>
    <org_study_id>SSS</org_study_id>
    <nct_id>NCT02215317</nct_id>
  </id_info>
  <brief_title>Sleep and Stent Study: a Multicentre, Prospective Study</brief_title>
  <official_title>Impact of Obstructive Sleep Apnea on Cardiovascular Outcomes in Patients Treated With Percutaneous Coronary Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National University of Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>National University of Singapore</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Elucidating the effects of obstructive sleep apnea (OSA) on cardiovascular outcomes is&#xD;
      crucial in risk assessments and therapeutic recommendations for affected individuals. The&#xD;
      Sleep and Stent Study is a multi-center observational study investigating the relationships&#xD;
      between OSA and cardiovascular outcomes in patients treated with percutaneous coronary&#xD;
      intervention (PCI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preliminary data suggest that OSA may lead to adverse cardiovascular outcomes after PCI.&#xD;
      However, existing data were generated from small-scale, single-center studies. Therefore, in&#xD;
      the Sleep and Stent Study, the investigators aim to conduct a large-scale multi-national&#xD;
      cohort study to determine the association between OSA and the incidence of adverse&#xD;
      cardiovascular outcomes over a long-term follow-up period. The investigators hypothesize that&#xD;
      OSA is an independent risk factor for the development of major adverse cardiovascular and&#xD;
      cerebrovascular events (MACCEs) in coronary artery disease patients treated with PCI. Results&#xD;
      from the Sleep and Stent Study will advance the fundamental understanding of the burden and&#xD;
      prognostic implications of OSA in patients undergoing PCI for coronary artery disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Major Adverse Cardiac and Cerebrovascular events (MACCE)</measure>
    <time_frame>Two years</time_frame>
    <description>Cardiovascular Death, Myocardial Infarction, Stroke/TIA, Unplanned revascularization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events other than MACCE</measure>
    <time_frame>Two years</time_frame>
    <description>All-cause mortality, Target vessel revascularization, Stent thrombosis, Hospitalization for heart failure.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1815</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>OSA group</arm_group_label>
    <description>Patients found to have OSA based on an overnight sleep study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-OSA group</arm_group_label>
    <description>Patients found not to have OSA based on an overnight sleep study</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        This is a prospective, observational multi-national cohort study of patients undergoing PCI&#xD;
        for coronary artery disease. Adult patients undergoing clinically indicated PCI for&#xD;
        coronary artery disease will be enrolled in the Sleep and Stent Study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years old and &lt; 80 years old&#xD;
&#xD;
          -  Successful PCI to at least one of the epicardial coronary arteries&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known OSA on CPAP treatment&#xD;
&#xD;
          -  Intubation for mechanical ventilation&#xD;
&#xD;
          -  Intra-aortic balloon pump or other hemodynamic support device&#xD;
&#xD;
          -  Sedation or other muscle relaxant given before overnight sleep study&#xD;
&#xD;
          -  Perceived high risk of malignant ventricular arrhythmia&#xD;
&#xD;
          -  Cardiogenic shock with systolic blood pressure &lt;90 mmHg&#xD;
&#xD;
          -  Clinical heart failure requiring oxygen supplementation&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  History of malignancy (except non-melanoma skin cancer, cervical in-situ carcinoma,&#xD;
             breast ductal carcinoma in situ or stage 1 prostate carcinoma)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chi-Hang Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National University Heart Centre, Singapore</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Venesa Loh</name>
      <address>
        <city>Singapore</city>
        <zip>119228</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <reference>
    <citation>Loo G, Koo CY, Zhang J, Li R, Sethi R, Ong TH, Tai BC, Lee CH. Impact of obstructive sleep apnea on cardiovascular outcomes in patients treated with percutaneous coronary intervention: rationale and design of the sleep and stent study. Clin Cardiol. 2014 May;37(5):261-9. doi: 10.1002/clc.22261.</citation>
    <PMID>24945037</PMID>
  </reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>February 22, 2017</last_update_submitted>
  <last_update_submitted_qc>February 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National University of Singapore</investigator_affiliation>
    <investigator_full_name>Chi-Hang Lee</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Sleep Apnea</keyword>
  <keyword>Stent</keyword>
  <keyword>Coronary Artery Disease</keyword>
  <keyword>Percutaneous Coronary Intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02215317
org study id: SSS
nct id: NCT02215317
lead sponsor: 
collaborator: 
has dmc: Yes
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).
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.
observational model: Cohort
time perspective: Prospective
measure: Number of Participants with Major Adverse Cardiac and Cerebrovascular events (MACCE)
time frame: Two years
description: Cardiovascular Death, Myocardial Infarction, Stroke/TIA, Unplanned revascularization
measure: Number of Participants with Adverse Events other than MACCE
time frame: Two years
description: All-cause mortality, Target vessel revascularization, Stent thrombosis, Hospitalization for heart failure.
arm group label: OSA group
description: Patients found to have OSA based on an overnight sleep study
arm group label: Non-OSA group
description: Patients found not to have OSA based on an overnight sleep study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Chi-Hang Lee, MD
role: Principal Investigator
affiliation: National University Heart Centre, Singapore
facility: 
country: Singapore
citation: Loo G, Koo CY, Zhang J, Li R, Sethi R, Ong TH, Tai BC, Lee CH. Impact of obstructive sleep apnea on cardiovascular outcomes in patients treated with percutaneous coronary intervention: rationale and design of the sleep and stent study. Clin Cardiol. 2014 May;37(5):261-9. doi: 10.1002/clc.22261.
PMID: 24945037
responsible party type: Principal Investigator
investigator affiliation: National University of Singapore
investigator full name: Chi-Hang Lee
investigator title: Associate Professor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive