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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04549272
Other study ID # LMB08
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT04604015 - RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt N/A
Active, not recruiting NCT04950192 - Philips Intracardiac Echocardiography (ICE) Clinical Registry
Completed NCT02621528 - Lifetech CeraFlex™ Post-Market Surveillance Study N/A
Terminated NCT01018355 - The Effect of Device Closure of Patent Foramen Ovale in Elderly Patients With Crytogenic Stoke/TCI N/A
Completed NCT00831259 - Risk of Stroke in Pulmonary Embolism With a Patent Foramen Ovale (PFO) N/A
Not yet recruiting NCT05360771 - Study on the Safety and Effectiveness of the SnowyTM PFO Closure System N/A
Recruiting NCT05546320 - Comparison of the Effect of Medication Therapy in Alleviating Migraine With Patent Foramen Ovale Phase 4
Recruiting NCT05561660 - COMParison of the EffecT of dEvice Closure in Alleviating Migraine With PFO (COMPETE-2) Phase 4
Completed NCT03904277 - Does Patent Foramen Ovale Size Matter in Men and Women
Recruiting NCT06120270 - CeraFlex PFO Closure System PMCF Study
Terminated NCT01773252 - Right to Left Cardiac Shunt Detection Phase 3
Completed NCT01216423 - Pulmonary Embolism and Stroke in Patient With Patent Foramen Ovale N/A
Completed NCT03377465 - Biomarkers, Hemodynamic and Echocardiographic Predictors of Ischemic Strokes and Their Influence on the Course and Prognosis N/A
Active, not recruiting NCT04738071 - International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry
Not yet recruiting NCT06413147 - Long-term Procedural and Device Related Complications of PFO Closure
Not yet recruiting NCT06344494 - Cardiac Interventional ICE Imaging Trial N/A
Withdrawn NCT02378623 - Patients With Patent Foramen Ovale and Endocardial Device Leads on Apixaban for Prevention of Paradoxical Emboli Phase 2