Early Identification of Patients With Coexisting Atrial Fibrillation and Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Number of Participants With Definite Atrial Fibrillation (Defined as an Irregularly Irregular Rhythm With Absence of p Waves)
研究概览
简要总结
The purpose of this research study is to learn about arrhythmia detection in obstructive sleep apnea (OSA). For several years patients with OSA have an increased likelihood of having irregular heartbeats. This study will determine how often patients with OSA have irregular heartbeats. This study will also define which OSA patients are most likely to have irregular heartbeats.
The participant is being asked to be in the study because the participant has been diagnosed with obstructive sleep apnea (OSA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of OSA within the last 12 months
- •No previous diagnosis of atrial fibrillation
- •Able and willing to follow-up as an outpatient
- •Age 40-85 years
排除标准
- •Life expectancy < 2 years
- •Dementia or other neurologic condition which would make outpatient follow-up difficult
- •CHADS score <2
- •Alcohol or drug abuse which would interfere with outpatient follow-up
- •Severe Congestive heart failure (NYHA class 3 or 4) or use of left ventricular assist device.
- •Current dialysis treatment or planned treatment within 12 months
- •Known bleeding disorder or prothrombin time >15 seconds
- •Mechanical heart valve requiring anticoagulation
- •Moderate to severe mitral stenosis or regurgitation
- •Prior clinical diagnosis of ischemic stroke (radiologic infarcts are not excluded)
- •Chronic obstructive pulmonary disease with oxygen dependence
- •Pregnant patients or patients that plan to become pregnant within the course of the study*.
- •Patients with anticipated need for a pacemaker during the course of the study *If any patients become pregnant during the course of the study, pregnancy outcomes will not be followed
结局指标
主要结局
Number of Participants With Definite Atrial Fibrillation (Defined as an Irregularly Irregular Rhythm With Absence of p Waves)
时间窗: Week 2
New cases of atrial fibrillation as evaluated by the LifestarAct III.
次要结局
- Number of Participants With Frequent Ventricular Premature Contractions(week 2)
- Longest Duration of Atrial Fibrillation(Week 2)
- Atrial Fibrillation Episodes Lasting More Than Six Minutes(Week 2)
- The Number of Participants With Frequent Premature Atrial Contractions(Week 2)
研究者
Alberto Rafael Ramos
Professor
University of Miami