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

April 8, 2022 updated by: Giuseppe Lembo, Neuromed IRCCS
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Patent Foramen Ovale
Other: No interventions
No interventions - observational study

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuromed IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

September 8, 2020

First Submitted That Met QC Criteria

September 8, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 8, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LMB08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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