Evaluation of Prevalence and Clinical Impact of Atrial Fibrillation in Elderly Patients With Cryptogenic Stroke and High-Risk Patent Foramen Ovale
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Paroxysmal AF episodes > 30 seconds detected with intermittent recordings or ≥ 2 minutes during ICM within 6 months
研究概览
简要总结
The purpose of DEFENSE-ELDERLY is to identify the prevalence of AF and evaluate the clinical impact of AF in elderly ESUS patients and no other known sources of stroke besides a high-risk patent foramen ovale, and compare it with elderly ESUS patients without high-risk PFO (no PFO or non-high risk PFOs)
详细描述
The purpose of DEFENSE-ELDERLY is to identify the prevalence of AF and evaluate the clinical impact of AF in elderly ESUS patients and no other known sources of stroke besides a high-risk patent foramen ovale, and compare it with elderly ESUS patients without high-risk PFO (no PFO or non-high risk PFOs)
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥60 y/o with ESUS and PFO that is likely to have causative role (high-risk anatomical feature) (cohort A)
- •Patients ≥60 y/o with ESUS without PFO, or with non-high risk PFO (cohort B)
- •The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the institutional review board
- •Patients who are scheduled to have implantable cardiac monitoring
排除标准
- •Transient ischemic attack
- •Lacunar infarction (infarction at subcortical area with a lesion diameter less than 2cm on MR)
- •Presence of complex aortic atheroma (≥4mm in plaque thickness or presence of mobile components)
- •Presence of ≥50% luminal stenosis (extra- or intracranial) in arteries supplying the ischemic area
- •Unwillingness or inability to comply with the procedures described in this protocol
- •Life expectancy < 1 years for any non-cardiac or cardiac causes
结局指标
主要结局
Paroxysmal AF episodes > 30 seconds detected with intermittent recordings or ≥ 2 minutes during ICM within 6 months
时间窗: Enrollment to 6 months
Paroxysmal AF episodes \> 30 seconds detected with intermittent recordings or ≥ 2 minutes during ICM within 6 months
次要结局
- Paroxysmal AF episodes > 30 seconds detected with intermittent recordings or ≥ 2 minutes during ICM within 36 months(Enrollment to 36 months)
- Paroxysmal AF episodes > 30 seconds detected with intermittent recordings or ≥ 6 minutes during ICM at 6 months and 36 months(6 months to 36 months)
- Rates of percutaneous device closure, prescription of anticoagulants (warfarin or direct oral anticoagulants)(Enrollment to 36 months)
- Recurrent stroke or TIA(Enrollment to 36 months)
- All-cause death, Vascular Death(Enrollment to 36 months)
研究者
Jae-Kwan Song
Jae-Kwan Song
Asan Medical Center