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

NCT04549272 | Unknown

• 1 other identifier: LMB08
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Keywords

Magnetic Resonance Imaging; Vascular Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Measurement of percentage change in diffusion parameters of the white matter

  Fiber tracking by DTI MRI

  At Enrollment

Secondary Outcomes (3)

• Quantification of the degree of shunt of the patent foramen ovale

  At Enrollment

• Detection of cognitive decline by decrease of MoCA score

  At Enrollment

• Detection of a non-invasive retinal screening

  At Enrollment

Study Arms (1)

Patients with Patent Foramen Ovale

Other: No interventions

Interventions

No interventions OTHER

No interventions - observational study

Patients with Patent Foramen Ovale

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuromed IRCCS: lead

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, plasma

MeSH Terms

Conditions

Foramen Ovale, Patent

Condition Hierarchy (Ancestors)

Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Giuseppe Lembo, MD, PhD

CONTACT

+390865915225; lembo@neuromed.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, MD, PhD

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 16, 2020
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share