Relationship Between Obstructive Sleep Apnea and Coronary Atherosclerosis

Coronary Artery Disease Clinical Trial

— IDEAS-OSA  

Official title:

Intravascular Ultrasound Diagnostic Evaluation of Atherosclerosis in Singapore- Obstructive Sleep Apnea (IDEAS-OSA) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306526
• Other study ID #: DSRB: C/10/341
• Status: Completed
• Phase: N/A
• First received: March 1, 2011
• Last updated: January 7, 2014
• Start date: February 2011
• Est. completion date: March 2013

Study information

• Verified date: January 2014
• Source: National University, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Ministry of Education
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Apnea
• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Singapore	National University Health System	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Atheroma Volume	Relationship between OSA and Total Atheroma Volume determined (IVUS) will be determined	Baseline	No
Secondary	Thin-cap fibroatheroma	Relation between OSA and prevalence of thin-cap fibroatheroma (VH-IVUS) will be determined	Baseline	No