Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-28 @ 11:39 AM
Study NCT ID:
NCT02701504
Status:
COMPLETED
Last Update Posted:
2020-03-26
First Post:
2014-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Undiagnosed Sleep Apnea and Bypass OperaTion
Sponsor:
National University of Singapore
Organization:
Study Overview
Official Title:
Association Between Sleep Apnea and Occurrence of Major Adverse Cardiovascular Events After Coronary Artery Bypass Grafting
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SABOT
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: