Clinical trial NCT02701504: Undiagnosed Sleep Apnea and Bypass OperaTion
Official title: Association Between Sleep Apnea and Occurrence of Major Adverse Cardiovascular Events After Coronary Artery Bypass Grafting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea
Keywords: sleep apnea
coronary artery bypass grafting
outcomes
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2016-03-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with coronary artery disease scheduled to undergo coronary artery bypass surgery

Brief summary: Sleep apnea is a prevalent disorder in patients with coronary artery disease. Previous studies suggested sleep apnea was associated with coronary plaque burden and future adverse cardiovascular events after percutaneous coronary intervention. In the SABOT study, the investigators used a FDA-approved portable sleep device to diagnose sleep apnea, and evaluate the relationship between sleep apnea and cardiovascular outcomes after non-urgent coronary artery bypass surgery.

Detailed description: The SABOT Study is an observational study designed to study the impact of sleep apnea on cardiovascular outcomes after non-urgent coronary artery bypass surgery (CABG). Patients between the ages of 18 and 90 who are scheduled undergo an non-urgent CABG were eligible for the study

The recruited patients participants were scheduled to undergo a hospital-based overnight sleep study using a US Food and Drug Administration-approved portable monitoring devices: the Watch-PAT (Itamar Medical, Caesarea, Israel). Watch-PAT is a four-channel unattended sleep monitoring device that measures peripheral arterial tone (PAT), pulse oximetry, heart rate, and actigraphy from a built-in actigraph. Respiratory events are identified by digital vasoconstriction mediated by α-adrenergic receptors that are sensitive to surges in sympathetic activity. Respiratory events are considered to be present when one of the following three criteria was met: a reduction in PAT amplitude with an acceleration of the pulse rate or an increase in wrist activity; a reduction in PAT amplitude with ≥3% oxyhemoglobin desaturation; and ≥4% oxyhemoglobin desaturation only. Although manual scoring and editing of the Watch-PAT signals are possible, we adopted results generated by the device algorithm alone with no intervention by the operator. The diagnosis of sleep apnea is confirmed if the AHI was greater than 15 events/h.

End Points The pre-specified primary end point is a major adverse cardiac and cerebrovascular event (MACCE), defined as a composite of cardiovascular mortality, non-fatal myocardial infarction, non-fatal stroke, and repeat revascularization.

The secondary end point comprised sudden cardiac death or resuscitated cardiac arrest, all-cause mortality, and hospitalization for heart failure.

Eligibility criteria: Inclusion Criteria:

* Patients with coronary artery disease scheduled to undergo non-urgent coronary artery bypass surgery

Exclusion Criteria:

* Known sleep apnea on CPAP therapy
* Cardiogenic shock on mechanical hemodynamic support
* Intubated on mechanical ventilation
* Heart failure on oxygen therapy
* Long -term alpha blocker therapy
* Severe chronic pulmonary disease
* Recurrent malignant arrhythmia
* Inability to provide informed consent

Primary outcomes:
measure: Major Adverse Cardiac and Cerebrovascular Events
timeFrame: Average of 2 years after CABG
Secondary outcomes:
measure: Other Cardiac and Cerebrovascular Events
timeFrame: Average of 2 years after CABG
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Heart Centre, Singapore
Study officials:
affiliation: National University of Singapore
name: Chi-Hang Lee, MD
role: STUDY_CHAIR
References:
citation: Aung AT, Koo CY, Tam WW, Chen Z, Kristanto W, Sim HW, Kojodjojo P, Kofidis T, Lee CH. Sleep apnea and diabetes mellitus are independently associated with cardiovascular events and hospitalization for heart failure after coronary artery bypass grafting. Sci Rep. 2020 Dec 10;10(1):21664. doi: 10.1038/s41598-020-78700-9.
citation: Koo CY, Aung AT, Chen Z, Kristanto W, Sim HW, Tam WW, Gochuico CF, Tan KA, Kang GS, Sorokin V, Ong PJL, Kojodjojo P, Richards AM, Tan HC, Kofidis T, Lee CH. Sleep apnoea and cardiovascular outcomes after coronary artery bypass grafting. Heart. 2020 Oct;106(19):1495-1502. doi: 10.1136/heartjnl-2019-316118. Epub 2020 May 18.