Assessment of Early Vascular Damage With Advanced Neuroimaging in Patient With Patent Foramen Ovale
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- Measurement of percentage change in diffusion parameters of the white matter
研究概览
简要总结
Patent foramen ovale arises from the incomplete postnatal fusion of the septum primum and secundum and can cause paradoxical embolism in adults. In case of cerebral ischemic stroke, the correlation with the patent foramen ovale is based on probabilistic approach. For this reason, continuous research is indispensable, especially according to new approaches, to offer tools capable of guiding in case of adverse event with greater certainty and even better to prevent it. Thus, this study aims to: 1) evaluate the microstructural brain damage through advanced MRI analysis in patients with patent foramen ovale; 2) evaluate how much the degree of the shunt can affect brain damage. In order to do this, this study aims to evaluate advanced brain imaging in a cohort of patients with patent foramen ovale to identify the development of early vascular damage.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 and ≤ 65 years
- •patients with patent foramen ovale
- •written informed consent
排除标准
- •previous IMA, stroke or TIA
- •arrhythmia or severe cardiac disease
- •hypertension, diabetes or renal disease
- •psychiatric disease
- •neurological or neurodegenerative disease
- •assumption of drugs known to interfere with cognitive function
- •inability to be subjected MRI analysis
- •participation to other clinical trial, ongoing or terminated less than one month before enrolment in this study.
结局指标
主要结局
Measurement of percentage change in diffusion parameters of the white matter
时间窗: At Enrollment
Fiber tracking by DTI MRI
次要结局
- Quantification of the degree of shunt of the patent foramen ovale(At Enrollment)
- Detection of cognitive decline by decrease of MoCA score(At Enrollment)
- Detection of a non-invasive retinal screening(At Enrollment)
研究者
Giuseppe Lembo
Full Professor, MD, PhD
Neuromed IRCCS