Prospective Clinical Follow-up of Patients Presenting With Cryptogenic Stroke Treated With the Percutaneous Closure of a Patent Foramen Ovale
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- residual shunt at 6-12 months follow-up
研究概览
简要总结
Following a cryptogenic stroke, many patients are nowadays treated with the percutaneous closure of a patent foramen ovale (PFO), assuming that the aetiology of the stroke is secondary to a paradoxical embolism. After the PFO closure procedure a dual antiplatelet regimen is often prescribed for 3-6 months and several cardiologic and neurologic follow-up exams are scheduled in the first 12 months of follow-up. Usually a transthoracic +/- transoesophageal echocardiography (TTE +/- TEE) are performed at 6 months, however this kind of control is not systematically performed. In order to improve the clinical outcomes in this young patients' population, the investigators prospectively perform a complete cardiologic and neurologic follow-up program to all patients undergoing a successful percutaneous closure of a PFO.
The aim of these controls is to confirm the good position of the PFO-device, to confirm the absence of any residual right to left shunt or any significant atrial arrhythmias Furthermore this prospective follow-up will analyze the possible mechanisms leading to a cerebral stroke recurrence (e.g. size of the PFO, presence of an atrial septal aneurysm, presence of a residual shunt, size of the utilized closure device, ....).
详细描述
At follow-up the following exams will be performed:
- at hospital discharge: chest X-ray +/- TTE + 7-days event loop record (ELR)
- at 6 months: clinical cardiologic and neurologic examination + TTE + TEE + 7-days ELR + trans-cranial doppler (TCD) with micro bubbles detection.
- at 1 year: clinical cardiologic and neurologic examination + TTE +/- TEE + 7-days ELR + trans-cranial doppler (TCD) with micro bubbles detection +/- cerebral MRI
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
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old patients
- •signed informed consent
- •all consecutive patients undergoing a successful percutaneous closure of a PFO secondary to a cryptogenic stroke
排除标准
- •all patients with an alternative aetiology of the initial stroke
- •all patients in whom the percutaneous closure of the PFO is contraindicated
- •all patients with a known allergy to aspirin and or clopidogrel
结局指标
主要结局
residual shunt at 6-12 months follow-up
时间窗: 6-12 months
incidence and clinical relevance of right to left residual shunts at 6-12 months after the successful closure of the PFO
possible other aetiologies of the initial cryptogenic stroke
时间窗: 6-12 months
during the 12 months follow-up all other possible aetiologies explaining the initial cryptogenic stroke will be taken into consideration
stroke recurrence
时间窗: 6-12 months
incidence and clinical predictors of stroke recurrence at 6-12 months
次要结局
- 6 months dual antiplatelet regimen safety and efficacy(6 months)
研究者
Robert F Bonvini
MD
University Hospital, Geneva
