Anticoagulants for PFO Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 277
- 主要终点
- whether occur recurrent stroke or migraine relief
研究概览
简要总结
Patients who underwent both bubble transcranial Doppler (bubble-TCD) and transoesophageal echocardiography (TEE) at our institution were consecutively enrolled in this real-world case-control study from August 2016 through August 2023. The patients were categorized into three groups based on the degree of the shunt observed: mild (3-9 bubbles), moderate (10-30bubbles), and severe (more than 30 bubbles). In cases with mild-shunt (small-size) PFO, post-procedural anticoagulation or PFO closure was administered. Subsequent to the interventions, the follow-up encompassed the recording of migraine remission, recurrent neurological incidents, instances of major bleeding, and mortality.
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
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •verified PFO diagnosis through TEE, Bubble-TCD, or contrast echocardiography of the right heart;
- •ages range between 16 and 65;
- •no restrictions on sexual orientation;
- •stroke patients with cryptogenic strokes as per the TOAST classification;
- •no other likely causes for migraines, with the exception of PFO;
- •no multiple risk factors for cerebrovascular disease, such as hypertension, diabetes, or smoking.
排除标准
- •severe, acute, or life-threatening conditions including acute cardio-cerebrovascular diseases, significant organ failure, or infections; 2)magnetic resonance imaging (MRI) contraindications, especially with contrast enhancement; 3) presence of cerebral artery stenosis, internal carotid artery stenosis, or atherosclerosis; 4) hypercoagulability or venous thrombosis; 5) contraindications associated with PFO closure and anticoagulants; 6) obstructive sleep apnea.
研究组 & 干预措施
small-shunt Group
small (3-9 bubbles)
干预措施: PFO closure (Procedure)
small-shunt Group
small (3-9 bubbles)
干预措施: anticoagulant (Drug)
moderate-shunt Group
(10-30 bubbles)
干预措施: PFO closure (Procedure)
moderate-shunt Group
(10-30 bubbles)
干预措施: anticoagulant (Drug)
large-shunt Group
>30 bubbles
干预措施: PFO closure (Procedure)
large-shunt Group
>30 bubbles
干预措施: anticoagulant (Drug)
结局指标
主要结局
whether occur recurrent stroke or migraine relief
时间窗: 12 months
次要结局
未报告次要终点