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临床试验/NCT01149447
NCT01149447Unknown不适用

Prospective Clinical Follow-up of Patients Presenting With Cryptogenic Stroke Treated With the Percutaneous Closure of a Patent Foramen Ovale

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2001年1月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert F Bonvini

MD

University Hospital, Geneva

研究点 (1)

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