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

NCT ID: NCT04549272

Last Updated: 2022-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-31
• Study Completion Date: 2023-10-31

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.

Conditions

Patent Foramen Ovale

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients with Patent Foramen Ovale

No interventions

Intervention Type: OTHER

No interventions - observational study

Interventions

No interventions

No interventions - observational study

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neuromed IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Giuseppe Lembo

Full Professor, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Giuseppe Lembo, MD, PhD

Role: CONTACT

lembo@neuromed.it

+390865915225

Other Identifiers

LMB08

Identifier Type: -

Identifier Source: org_study_id