Clinical trial NCT01306526: Relationship Between Obstructive Sleep Apnea and Coronary Atherosclerosis
Official title: Intravascular Ultrasound Diagnostic Evaluation of Atherosclerosis in Singapore- Obstructive Sleep Apnea (IDEAS-OSA) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Obstructive Sleep Apnea
Keywords: Thin-cap fibroatheroma
Vulnerable plaque
Coronary artery disease
Obstructive sleep apnea
Intravascular Ultrasound
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2011-03-02
Enrollment: 118
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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.


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

Primary outcomes:
measure: Total Atheroma Volume
timeFrame: Baseline
Secondary outcomes:
measure: Thin-cap fibroatheroma
timeFrame: Baseline
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Health System
Study officials:
References:
citation: 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.
citation: 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.