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临床试验/NCT02701504
NCT02701504已完成不适用

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

National University of Singapore1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2013年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,000
试验地点
1
主要终点
Major Adverse Cardiac and Cerebrovascular Events

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Major Adverse Cardiac and Cerebrovascular Events

时间窗: Average of 2 years after CABG

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

次要结局

  • Other Cardiac and Cerebrovascular Events(Average of 2 years after CABG)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chi-Hang Lee

Associate Professor

National University of Singapore

研究点 (1)

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