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

Patent Foramen Ovale Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04549272
• Other study ID #: LMB08
• Status: Not yet recruiting
• Start date: October 2022
• Est. completion date: October 2023

Study information

• Verified date: April 2022
• Source: Neuromed IRCCS
• Contact: Giuseppe Lembo, MD, PhD
• Phone: +390865915225
• Email: lembo[@]neuromed.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Patent Foramen Ovale

Intervention

Other:
• No interventions
No interventions - observational study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Neuromed IRCCS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of percentage change in diffusion parameters of the white matter	Fiber tracking by DTI MRI	At Enrollment
Secondary	Quantification of the degree of shunt of the patent foramen ovale	Echography	At Enrollment
Secondary	Detection of cognitive decline by decrease of MoCA score	Cognitive tests	At Enrollment
Secondary	Detection of a non-invasive retinal screening	Digital ophthalmoscope	At Enrollment