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OpenTrials
Completed

NCT Number: NCT02701504

Undiagnosed Sleep Apnea and Bypass OperaTion

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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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National University Heart Centre, Singapore

Singapore, 119228

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Major Adverse Cardiac and Cerebrovascular Events

    Time frame: Average of 2 years after CABG

    The number of patients with cardiac mortality, stroke, myocardial infarction, or repeat revascularization

Secondary outcomes

  1. Other Cardiac and Cerebrovascular Events

    Time frame: Average of 2 years after CABG

    Sudden cardiac death or resuscitated cardiac arrest, all-cause mortality, hospitalization for heart failure,

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Registry information

Official study title

Association Between Sleep Apnea and Occurrence of Major Adverse Cardiovascular Events After Coronary Artery Bypass Grafting

Acronym: SABOT

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Mar 8, 2016
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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