Prospective Registry of Elderly Patients With ESUS to Evaluate the Role of Covert Atrial Fibrillation and Patent Foramen Ovale
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- ischemic stroke recurrence
研究概览
简要总结
Patent foramen ovale (PFO) is associated with an increased risk of stroke. PFO-closure was effective in preventing stroke in young stroke patients less than age 60 presented as an embolic stroke of undetermined source (ESUS). However, the benefit of PFO-closure in elderly ESUS patients is not clear. The investigators designed this prospective register-based observational study to verify the efficacy of PFO-closure in elderly ESUS patients with high-risk PFO, older than 60 years
详细描述
The COACH-ELDERLY ESUS study is a multicenter, prospective, registry-based, observational study in elderly ESUS patients with high-risk PFO treated with PFO-closure + standard antiplatelet treatment or standard antiplatelet treatment only in 20 centers in Korea.
Patients will receive an insertable loop recorder (ILR) to monitor paroxysmal atrial fibrillation. In cases, which are unavailable for ILR, recurrent EKG or Holter monitoring will be done based on the clinician's decision. Based on the attending physicians' decision with a multi-disciplinary approach, patients will receive PFO-closure with standard antiplatelet treatment or standard antiplatelet treatment only.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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 older than 60 years-old
- •Patients diagnosed as ESUS within 180 days from onset
- •PFO found from TTE or TEE, which attributed to the ischemic stroke
- •Patients or their legal representative agreed to participate
排除标准
- •Patients with transient ischemic attack
- •Patients with ischemic stroke at the vascular territory with significant stenosis
- •Patients with high risk cardioembolic stroke detected from EKG, Holter monitoring or echocardiography
- •Patients with other causes which may cause stroke (i.e. vasculitis, dissection, vasospasm, drug related or Moyamoya disease)
- •Patients with active cancer
- •Patients who need long term anticoagulation
- •Patients who have side effect on antiplatelet treatment
- •Patients with active internal bleeding
- •Patients who refuse to participate
结局指标
主要结局
ischemic stroke recurrence
时间窗: at least 1 year
Time to occurrence of ischemic stroke after registration
次要结局
- Hemorrhagic stroke(at least 1 year)
- Myocardial infarction(at least 1 year)
- Atrial fibrillation lasting more than 2 or 6 min after registration(at least 1 year)
- Atrial fibrillation after registration(at least 1 year)
- MACE(at least 1 year)
- Major bleeding(at least 1 year)
- Vascular death(at least 1 year)
研究者
Sun U. Kwon
Professor
Asan Medical Center