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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Patent Foramen Ovale |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No interventions | Other | No interventions - observational study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of percentage change in diffusion parameters of the white matter | Fiber tracking by DTI MRI | At Enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Quantification of the degree of shunt of the patent foramen ovale | Echography | At Enrollment |
| Detection of cognitive decline by decrease of MoCA score | Cognitive tests |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be selected from patients attending the Department of AngioCardioNeurology of the IRCCS Neuromed, accordingly to the following inclusion/exclusion criteria. Approximately 100 subjects of both genders will be included in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giuseppe Lembo, MD, PhD | Contact | +390865915225 | lembo@neuromed.it |
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| ID | Term |
|---|---|
| D054092 | Foramen Ovale, Patent |
| ID | Term |
|---|---|
| D006344 | Heart Septal Defects, Atrial |
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
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Whole blood, serum, plasma
| At Enrollment |
| Detection of a non-invasive retinal screening | Digital ophthalmoscope | At Enrollment |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |