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

Neuromed IRCCS

Status: Unknown

Conditions: Patent Foramen Ovale

Treatments: Other: No interventions

Study type: Observational

Funder types: Other

Identifiers

NCT04549272

LMB08

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Patients with Patent Foramen Ovale

Treatment:

Other: No interventions