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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04549272

Enrollment

100

Registered

2020-09-16

Start date

2022-10-31

Completion date

2023-10-31

Last updated

2022-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patent Foramen Ovale

Keywords

Magnetic Resonance Imaging, Vascular Cognitive Impairment

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.

Interventions

OTHERNo interventions

No interventions - observational study

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Measurement of percentage change in diffusion parameters of the white matter	At Enrollment	Fiber tracking by DTI MRI

Secondary

Measure	Time frame	Description
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

Contacts

Primary ContactGiuseppe Lembo, MD, PhD

lembo@neuromed.it+390865915225

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026