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Relationship Between Obstructive Sleep Apnea and Coronary Atherosclerosis (IDEAS-OSA)

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.
 
ClinicalTrials.gov Identifier: NCT01306526
Recruitment Status : Completed
First Posted : March 2, 2011
Last Update Posted : January 9, 2014
Sponsor:
Information provided by (Responsible Party):
Chi-Hang Lee, National University, Singapore

Tracking Information
First Submitted Date March 1, 2011
First Posted Date March 2, 2011
Last Update Posted Date January 9, 2014
Study Start Date February 2011
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 7, 2014)
Total Atheroma Volume [ Time Frame: Baseline ]
Relationship between OSA and Total Atheroma Volume determined (IVUS) will be determined
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: January 7, 2014)
Thin-cap fibroatheroma [ Time Frame: Baseline ]
Relation between OSA and prevalence of thin-cap fibroatheroma (VH-IVUS) will be determined
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Relationship Between Obstructive Sleep Apnea and Coronary Atherosclerosis
Official Title Intravascular Ultrasound Diagnostic Evaluation of Atherosclerosis in Singapore- Obstructive Sleep Apnea (IDEAS-OSA) Study
Brief Summary Obstructive sleep apnea (OSA) is a respiratory disorder of sleep characterized by recurrent episodes of complete or partial upper airway obstruction, leading to intermittent oxygen deprivation. This results in sympathetic activation and surges in blood pressure, production of vasoactive substances, as well as activation of the inflammatory and procoagulant pathways. Epidemiological evidence indicates the prevalence of OSA is higher in patients with coronary artery disease than in the general population. The investigators recently showed that 65.7% and 41.9% of the Singapore patients admitted with myocardial infarction were found to have previously undiagnosed OSA and severe OSA, respectively. In a 10-year follow-up epidemiological study, OSA was independently associated with a higher prevalence of fatal and non-fatal cardiovascular events among the otherwise healthy general population. The investigators further showed that in patients who have undergone primary percutaneous coronary intervention for acute myocardial infarction, OSA was an independent predictor of future adverse event rates. Despite the observed association between OSA and adverse cardiovascular outcomes, the underlying pathophysiological mechanisms remain unclear. In this proposal, the investigators aim to elucidate the relationship between OSA and composition of coronary atherosclerotic plaques.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients aged 21 to 80 years who are scheduled to undergo either an elective, urgent or emergent diagnostic coronary angiography are eligible
Condition
  • Coronary Artery Disease
  • Obstructive Sleep Apnea
Intervention Not Provided
Study Groups/Cohorts Moderate to Severe OSA
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 7, 2014)
118
Original Estimated Enrollment
 (submitted: March 1, 2011)
135
Actual Study Completion Date March 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Angiogrqaphically documented coronary artery disease
  • De novo lesion
  • Native coronary artery

Exclusion Criteria:

  • known OSA
  • intubation and mechanical ventilation
  • electrical instability with a high risk of malignant ventricular arrhythmia
  • cardiogenic shock
  • previous coronary artery bypass surgery
  • chronic renal failure on dialysis
  • inability to give informed consent
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Singapore
Removed Location Countries  
 
Administrative Information
NCT Number NCT01306526
Other Study ID Numbers DSRB: C/10/341
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Chi-Hang Lee, National University, Singapore
Study Sponsor National University, Singapore
Collaborators Not Provided
Investigators Not Provided
PRS Account National University, Singapore
Verification Date January 2014