Relationship Between Obstructive Sleep Apnea and Coronary Atherosclerosis

NCT ID: NCT01306526

Last Updated: 2014-01-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 118 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-03-31

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.

Conditions

Coronary Artery Disease; Obstructive Sleep Apnea

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Moderate to Severe OSA

No interventions assigned to this group

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University of Singapore

OTHER

Sponsor Role: lead

Responsible Party

Chi-Hang Lee

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National University Health System

Singapore, Singapore, Singapore

Countries

Singapore

References

Lee CH, Sethi R, Li R, Ho HH, Hein T, Jim MH, Loo G, Koo CY, Gao XF, Chandra S, Yang XX, Furlan SF, Ge Z, Mundhekar A, Zhang WW, Uchoa CH, Kharwar RB, Chan PF, Chen SL, Chan MY, Richards AM, Tan HC, Ong TH, Roldan G, Tai BC, Drager LF, Zhang JJ. Obstructive Sleep Apnea and Cardiovascular Events After Percutaneous Coronary Intervention. Circulation. 2016 May 24;133(21):2008-17. doi: 10.1161/CIRCULATIONAHA.115.019392. Epub 2016 May 13.

Reference Type: DERIVED

PMID: 27178625 (View on PubMed)

Tan A, Hau W, Ho HH, Ghaem Maralani H, Loo G, Khoo SM, Tai BC, Richards AM, Ong P, Lee CH. OSA and coronary plaque characteristics. Chest. 2014 Feb;145(2):322-330. doi: 10.1378/chest.13-1163.

Reference Type: DERIVED

PMID: 24178625 (View on PubMed)

Other Identifiers

DSRB: C/10/341

Identifier Type: -

Identifier Source: org_study_id