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

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

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.

Condition or disease
Coronary Artery Disease Obstructive Sleep Apnea

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Study Type : Observational
Actual Enrollment : 118 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Intravascular Ultrasound Diagnostic Evaluation of Atherosclerosis in Singapore- Obstructive Sleep Apnea (IDEAS-OSA) Study
Study Start Date : February 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Moderate to Severe OSA

Primary Outcome Measures :
  1. Total Atheroma Volume [ Time Frame: Baseline ]
    Relationship between OSA and Total Atheroma Volume determined (IVUS) will be determined

Secondary Outcome Measures :
  1. Thin-cap fibroatheroma [ Time Frame: Baseline ]
    Relation between OSA and prevalence of thin-cap fibroatheroma (VH-IVUS) will be determined

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

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 ClinicalTrials.gov identifier (NCT number): NCT01306526

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National University Health System
Singapore, Singapore, 119074
Sponsors and Collaborators
National University, Singapore
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chi-Hang Lee, Associate Professor, National University, Singapore
ClinicalTrials.gov Identifier: NCT01306526    
Other Study ID Numbers: DSRB: C/10/341
First Posted: March 2, 2011    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014
Keywords provided by Chi-Hang Lee, National University, Singapore:
Thin-cap fibroatheroma
Vulnerable plaque
Coronary artery disease
Obstructive sleep apnea
Intravascular Ultrasound
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases