Undiagnosed Sleep Apnea and Bypass OperaTion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-01

Study Completion Date

2019-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sleep Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sleep apnea group

The patients who are found to have sleep apnea based on the results of the portable sleep study

No interventions assigned to this group

Non sleep apnea group

The patients who are found to have no sleep apnea based on the results of the portable sleep study

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No