Patent Foramen OvaleNCT04549272
Assessment of Early Vascular Damage With Advanced Neuroimaging in Patient With Patent Foramen Ovale
An observational study of Patent Foramen Ovale, run by Neuromed IRCCS.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patent Foramen Ovale
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- age ≥ 18 and ≤ 65 years
- patients with patent foramen ovale
- written informed consent
Who cannot join
- previous IMA, stroke or TIA
- arrhythmia or severe cardiac disease
- hypertension, diabetes or renal disease
- psychiatric disease
- neurological or neurodegenerative disease
- dementia
Show all 9Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- No interventions
- Keywords
- Magnetic Resonance Imaging, Vascular Cognitive Impairment
- Medical subject headings
- Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
No interventions - observational study
| Study group | Role | What they receive |
|---|---|---|
| Patients with Patent Foramen Ovale | Not described Receives: Other: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of percentage change in diffusion parameters of the white matter
Fiber tracking by DTI MRI
Measured: At Enrollment
Secondary outcomes (3)
Quantification of the degree of shunt of the patent foramen ovale
Echography
Measured: At Enrollment
Detection of cognitive decline by decrease of MoCA score
Cognitive tests
Measured: At Enrollment
Detection of a non-invasive retinal screening
Digital ophthalmoscope
Measured: At Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study startOct 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Foramen OvaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Lembo, Neuromed IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549272
- Sponsor's protocol ID
- LMB08
- Status last verified
- Apr 2022
- First submitted
- 8 Sep 2020
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Early Vascular Damage With Advanced Neuroimaging in Patient With Patent Foramen Ovale
- ClinicalTrials.gov ID
- NCT04549272
- Acronym / sponsor ID
- LMB08
- Conditions
- Patent Foramen Ovale
- Keywords
- Magnetic Resonance Imaging, Vascular Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Patent Foramen Ovale | – | Other: No interventions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- age ≥ 18 and ≤ 65 years
- patients with patent foramen ovale
- written informed consent
Key exclusion criteria (9 listed)
- previous IMA, stroke or TIA
- arrhythmia or severe cardiac disease
- hypertension, diabetes or renal disease
- psychiatric disease
- neurological or neurodegenerative disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionsNo interventions - observational study | Other | Patients with Patent Foramen Ovale |
Primary outcome
Measurement of percentage change in diffusion parameters of the white matter
Time frame: At Enrollment
Fiber tracking by DTI MRI
3 secondary outcomes
Quantification of the degree of shunt of the patent foramen ovale
Time frame: At Enrollment
Detection of cognitive decline by decrease of MoCA score
Time frame: At Enrollment
Detection of a non-invasive retinal screening
Time frame: At Enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Foramen Ovale, run by Neuromed IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Lembo, MD, PhD (+390865915225, lembo@neuromed.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of percentage change in diffusion parameters of the white matter (time frame: At Enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.