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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chi-Hang Lee, National University, Singapore
ClinicalTrials.gov Identifier:
NCT01306526
First received: March 1, 2011
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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
Coronary Artery Disease
Obstructive Sleep Apnea

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Intravascular Ultrasound Diagnostic Evaluation of Atherosclerosis in Singapore- Obstructive Sleep Apnea (IDEAS-OSA) Study

Resource links provided by NLM:


Further study details as provided by National University, Singapore:

Primary Outcome Measures:
  • Total Atheroma Volume [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Relationship between OSA and Total Atheroma Volume determined (IVUS) will be determined


Secondary Outcome Measures:
  • Thin-cap fibroatheroma [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Relation between OSA and prevalence of thin-cap fibroatheroma (VH-IVUS) will be determined


Enrollment: 118
Study Start Date: February 2011
Study Completion Date: March 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Moderate to Severe OSA

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306526

Locations
Singapore
National University Health System
Singapore, Singapore, 119074
Sponsors and Collaborators
National University, Singapore
  More Information

No publications provided

Responsible Party: Chi-Hang Lee, Associate Professor, National University, Singapore
ClinicalTrials.gov Identifier: NCT01306526     History of Changes
Other Study ID Numbers: DSRB: C/10/341
Study First Received: March 1, 2011
Last Updated: January 7, 2014
Health Authority: Singapore: Ministry of Education

Keywords provided by National University, Singapore:
Thin-cap fibroatheroma
Vulnerable plaque
Coronary artery disease
Obstructive sleep apnea
Intravascular Ultrasound

Additional relevant MeSH terms:
Apnea
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 15, 2014