Undiagnosed Sleep Apnea and Bypass OperaTion

Completed

• Conditions: Sleep Apnea

• Registration Number: NCT02701504
• Lead Sponsor: National University of Singapore

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.

Study Timeline

• Study Start: 2013-10-01
• Study First Submitted: 2014-09-23
• Study First Submitted QC: 2016-03-07
• Study First Posted: 2016-03-08
• Primary Completion: 2019-03-31
• Study Completion: 2019-03-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-25
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac and Cerebrovascular Events	Average of 2 years after CABG	The number of patients with cardiac mortality, stroke, myocardial infarction, or repeat revascularization

Secondary Outcome Measures

Name	Time	Method
Other Cardiac and Cerebrovascular Events	Average of 2 years after CABG	Sudden cardiac death or resuscitated cardiac arrest, all-cause mortality, hospitalization for heart failure,

Trial Locations

Locations (1)

National University Heart Centre, Singapore; 🇸🇬 Singapore, Singapore