Assessment of Early Vascular Damage With Advanced Neuroimaging in Patient With Patent Foramen Ovale

• Conditions: Patent Foramen Ovale
• Interventions: Other: No interventions

• Registration Number: NCT04549272
• Lead Sponsor: Neuromed IRCCS

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-16
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-08
• Last Update Posted: 2022-04-11
• Study Start: 2022-10
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• age ≥ 18 and ≤ 65 years
• patients with patent foramen ovale
• written informed consent

Exclusion Criteria

• previous IMA, stroke or TIA
• arrhythmia or severe cardiac disease
• hypertension, diabetes or renal disease
• psychiatric disease
• neurological or neurodegenerative disease
• dementia
• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Patent Foramen Ovale	No interventions	-

Primary Outcome Measures

Name	Time	Method
Measurement of percentage change in diffusion parameters of the white matter	At Enrollment	Fiber tracking by DTI MRI

Secondary Outcome Measures

Name	Time	Method
Quantification of the degree of shunt of the patent foramen ovale	At Enrollment	Echography
Detection of cognitive decline by decrease of MoCA score	At Enrollment	Cognitive tests
Detection of a non-invasive retinal screening	At Enrollment	Digital ophthalmoscope