Pioneering Advancements in Cardiocerebrovascular Interactions in the Asia pacFIC - Patent Foramen Ovale Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Recurrent ischemic stroke or transient ischemic attack event within 1 year
研究概览
简要总结
A registry of patients from the Asia-Pacific region with PFO and ischemic stroke, designed to study the characteristics, investigations, treatment and outcomes using real-world data.
详细描述
This is an observational, multi-center, non-randomized real-world registry including ischemic stroke and/or transient ischemic attack patients with PFO in the Asia Pacific region. The primary objective of this registry is to assess the clinical characteristics and outcomes of patients with PFO and stroke or TIA using real-world data in the Asia-Pacific region, including patients who underwent PFO closure versus medical management only.
Patients who had ischemic stroke or TIA within 5 years of inclusion into the registry, with follow up data of at least 1 year. Patients with AIS or TIA within one year of inclusion into the registry will be part of the prospective cohort. The total duration of the registry will be approximately 3 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Patients diagnosed with patient foramen ovale and ischemic stroke or transient ischemic attack.
The PACIFIC-PFO registry aims to include patients from Asia and Oceania. Academic, non-academic, urban and rural sites will be included. Principal investigators will be neurologists or cardiologists. A confirmed diagnosis of ischemic stroke or TIA is mandatory before enrolment. Information on the interventions performed and treatment instigated (e.g. PFO closure, medical therapy) will be collected.
干预措施: PFO closure using approved PFO closure devices, Surgical PFO closure (Procedure)
Patients diagnosed with patient foramen ovale and ischemic stroke or transient ischemic attack.
The PACIFIC-PFO registry aims to include patients from Asia and Oceania. Academic, non-academic, urban and rural sites will be included. Principal investigators will be neurologists or cardiologists. A confirmed diagnosis of ischemic stroke or TIA is mandatory before enrolment. Information on the interventions performed and treatment instigated (e.g. PFO closure, medical therapy) will be collected.
干预措施: Medical management (Drug)
结局指标
主要结局
Recurrent ischemic stroke or transient ischemic attack event within 1 year
时间窗: Within 1 year
Ischemic stroke is defined as: Acute focal neurological dysfunction caused by focal infarction at single or multiple sites of the brain or retina. Evidence of acute infarction may come either from A) Symptom duration lasting more than 24 hours B) Neuroimaging or other technique in the clinically relevant area of the brain TIA is defined as: A transient episode of focal neurological dysfunction caused by focal brain or retinal ischemia without acute infarction in the clinically relevant area of the brain or retina. Symptoms should resolve completely within 24 hours.
次要结局
- Short term and long term neurological and cardiovascular outcomes(90 days, 1 year, >1 year)
- Modified Rankin Scale (mRS)(90 days)