An observational study in Patent Foramen Ovale, sponsored by Neuromed IRCCS. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-04-11.
Sponsored by Neuromed IRCCS · Observational
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.
134 studies on the registry are indexed under Foramen Ovale, Patent; 46 are open to participants now.
This study's planned enrollment of 100 is below the median of 226 across 57 observational studies indexed under Foramen Ovale, Patent.
Browse Foramen Ovale, Patent studies →Neuromed IRCCS is the lead sponsor of 76 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Other: No interventions
No interventions - observational study
Measurement of percentage change in diffusion parameters of the white matter
Fiber tracking by DTI MRI
Time frame: At Enrollment
Quantification of the degree of shunt of the patent foramen ovale
Echography
Time frame: At Enrollment
Detection of cognitive decline by decrease of MoCA score
Cognitive tests
Time frame: At Enrollment
Detection of a non-invasive retinal screening
Digital ophthalmoscope
Time frame: At Enrollment
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Neuromed IRCCS