Foramen Ovale, PatentEPIC-FOPCohortNCT04987008
Risk of Ischaemic Stroke After Pulmonary Embolism in Patients With and Without Patent Foramen Ovale
An observational study of Foramen Ovale, Patent, run by University Hospital, Brest at 3 sites in France.
Trial summary
stroke's risk is increased in patients with pulmonary embolism and PFO compared to patients without PFO. Does this increased risk persist years after pulmonary embolism ? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foramen Ovale, Patent
- How many people
- 53 participants
- Where
- 3 sitesFrance
- Study dates
- 18 May 2021to 31 Aug 2021
- 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 years and older
- All sexes
- Adult, Older adult
Study population: 53 of the 324 EPIC-FOP patients not followed in previous PE cohort
Who may be able to join
- patients included in EPIC-FOP study
Who cannot join
- refusal to participate
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
HIA
Brest, 29600
Marc Danguy des Déserts
- Recruiting
CHRU de Brest
Brest, 29609
Emmanuelle LE MOIGNE
- Recruiting
CHIC de Quimper
Quimper, 29000
Thierry JOSEPH
About this study
Official title: Risk of Ischaemic Stroke After Pulmonary Embolism in Patients With and Without Patent Foramen Ovale (29BRC21.0082)
stroke's risk is increased in patients with pulmonary embolism and PFO compared to patients without PFO. Does this increased risk persist years after pulmonary embolism ?
Read the detailed description
324 patients included in EPIC-FOP study (2009 to 2015) were followed annually to collect data about the recurrence of VTE, cardiovascular events and treatments.
- Conditions
- Foramen Ovale, Patent
- Keywords
- foramen ovale, patent, stroke, pulmonary embolism
- Medical subject headings
- Foramen Ovale, Patent, Stroke, Pulmonary Embolism
What is being measured
The primary outcome is the main question the study is designed to answer.
stroke
documented stroke
Measured: pulmonary embolism (2009 to 2015) to 2021
Secondary outcomes (4)
TIA or stroke
documented TIA or stroke
Measured: pulmonary embolism (2009 to 2015) to 2021
death
all deaths and cardiovascular deaths
Measured: pulmonary embolism (2009 to 2015) to 2021
bleeding
Major and clinically pertinent bleeding (ISTH classification)
Measured: pulmonary embolism (2009 to 2015) to 2021
VTE
recurrent VTE
Measured: pulmonary embolism (2009 to 2015) to 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start18 May 2021
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foramen Ovale, PatentStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987008
- Sponsor's protocol ID
- Cohorte EPIC-FOP
- Acronym
- EPIC-FOPCohort
- Status last verified
- Apr 2021
- First submitted
- 27 Jul 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Ischaemic Stroke After Pulmonary Embolism in Patients With and Without Patent Foramen Ovale (29BRC21.0082)
- ClinicalTrials.gov ID
- NCT04987008
- Acronym / sponsor ID
- EPIC-FOPCohort / Cohorte EPIC-FOP
- Conditions
- Foramen Ovale, Patent
- Keywords
- foramen ovale, patent, stroke, pulmonary embolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 3 Aug 2021 (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.
stroke's risk is increased in patients with pulmonary embolism and PFO compared to patients without PFO. Does this increased risk persist years after pulmonary embolism ?
Detailed description
324 patients included in EPIC-FOP study (2009 to 2015) were followed annually to collect data about the recurrence of VTE, cardiovascular events and treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 53 of the 324 EPIC-FOP patients not followed in previous PE cohort
Key inclusion criteria (1 listed)
- patients included in EPIC-FOP study
Key exclusion criteria (1 listed)
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
stroke
Time frame: pulmonary embolism (2009 to 2015) to 2021
documented stroke
4 secondary outcomes
TIA or stroke
Time frame: pulmonary embolism (2009 to 2015) to 2021
death
Time frame: pulmonary embolism (2009 to 2015) to 2021
bleeding
Time frame: pulmonary embolism (2009 to 2015) to 2021
VTE
Time frame: pulmonary embolism (2009 to 2015) to 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Foramen Ovale, Patent, run by University Hospital, Brest at 3 sites in France.
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 1 inclusion and 1 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 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Emmanuelle LE MOIGNE (0298347344, emmanuelle.lemoigne@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stroke (time frame: pulmonary embolism (2009 to 2015) to 2021). 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 3 Aug 2021.