Recent StrokeEPIC-FOPNCT01216423
Pulmonary Embolism and Stroke in Patient With Patent Foramen Ovale
An observational study of Recent Stroke and Pulmonary Embolism, run by University Hospital, Brest at 4 sites in France.
Trial summary
The cause of ischemic stroke remains frequently unknown. In patients with patent foramen ovale (PFO), the link between PFO and Stroke is unclear. The investigators hypothesize that the main mechanism is paradoxical embolism and decided to look for clinically apparent and silent cerebral embolism in patients with a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recent Stroke, Pulmonary Embolism, Patent Foramen Ovale
- How many people
- 374 participants
- Where
- 4 sitesFrance
- Study dates
- Nov 2009to Jan 2017
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive series of hospitalized patients with pulmonary embolism
Who may be able to join
- age > 18 years old
- confirmed pulmonary embolism
- informed consent
- social ensured
Who cannot join
- pregnancy
- age < 18 years old
- protected major person (in sense of public health)
- consent refused
- MRI contraindications
Trial locations and contacts
4 sites in 1 country.
France4 sites
Army Hospital
Brest, France, 29200
Brest University Hospital
Brest, 29 609
CHU Dijon de Bocage
Dijon, France, 21079
Centre Hospitalier de Cornouaille
Quimper, France, 29107
About this study
Official title: Is There a Link Between Venous Thromboembolism and Stroke in Patient With Patent Foramen Ovale ? Research for Stroke in Hospitalized Patients With Pulmonary Embolism.
The cause of ischemic stroke remains frequently unknown. In patients with patent foramen ovale (PFO), the link between PFO and Stroke is unclear. The investigators hypothesize that the main mechanism is paradoxical embolism and decided to look for clinically apparent and silent cerebral embolism in patients with a recent pulmonary embolism.
Read the detailed description
Inclusion criteria :
- age > 18 years old
- confirmed pulmonary embolism
- informed consent
- social ensured
Exclusion criteria :
- pregnancy
- age < 18 years old
- protected major person (in sense of public health)
- consent refused
- MRI contraindications
- Conditions
- Recent Stroke, Pulmonary Embolism, Patent Foramen Ovale
- Keywords
- Patent Foramen Ovale, Pulmonary embolism, Stroke
- Medical subject headings
- Pulmonary Embolism, Foramen Ovale, Patent, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Incidence of recent stroke in patients with PFO | Not described | |
| Incidence of recent stroke in patients without PFO | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of recent ischemic stroke in patients hospitalized for a recent pulmonary embolism with comparison in two groups with and without PFO
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startNov 2009
- Primary completionDec 2015
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recent StrokeStudies 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
- Prospective
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuelle LE MOIGNE, MD, Principal investigator, University Hospital, Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216423
- Sponsor's protocol ID
- EPIC-FOP
- Acronym
- EPIC-FOP
- Status last verified
- Jan 2017
- First submitted
- 29 Sep 2010
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Le Moigne E, Timsit S, Ben Salem D, Didier R, Jobic Y, Paleiron N, Le Mao R, Joseph T, Hoffmann C, Dion A, Rousset J, Le Gal G, Lacut K, Leroyer C, Mottier D, Couturaud F. Patent Foramen Ovale and Ischemic Stroke in Patients With Pulmonary Embolism: A Prospective Cohort Study. Ann Intern Med. 2019 Jun 4;170(11):756-763. doi: 10.7326/M18-3485. Epub 2019 May 7.
PubMed 31060047
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Link Between Venous Thromboembolism and Stroke in Patient With Patent Foramen Ovale ? Research for Stroke in Hospitalized Patients With Pulmonary Embolism.
- ClinicalTrials.gov ID
- NCT01216423
- Acronym / sponsor ID
- EPIC-FOP / EPIC-FOP
- Conditions
- Recent Stroke, Pulmonary Embolism, Patent Foramen Ovale
- Keywords
- Patent Foramen Ovale, Pulmonary embolism, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 7 Oct 2010 (estimated)
- 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.
The cause of ischemic stroke remains frequently unknown. In patients with patent foramen ovale (PFO), the link between PFO and Stroke is unclear. The investigators hypothesize that the main mechanism is paradoxical embolism and decided to look for clinically apparent and silent cerebral embolism in patients with a recent pulmonary embolism.
Detailed description
Inclusion criteria :
- age > 18 years old
- confirmed pulmonary embolism
- informed consent
- social ensured
Exclusion criteria :
- pregnancy
- age < 18 years old
- protected major person (in sense of public health)
- consent refused
- MRI contraindications
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incidence of recent stroke in patients with PFO | – | – |
| Incidence of recent stroke in patients without PFO | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive series of hospitalized patients with pulmonary embolism
Key inclusion criteria (4 listed)
- age > 18 years old
- confirmed pulmonary embolism
- informed consent
- social ensured
Key exclusion criteria (5 listed)
- pregnancy
- age < 18 years old
- protected major person (in sense of public health)
- consent refused
- MRI contraindications
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
Incidence of recent ischemic stroke in patients hospitalized for a recent pulmonary embolism with comparison in two groups with and without PFO
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Derived from this study: PubMed 31060047Le Moigne E, Timsit S, Ben Salem D, Didier R, Jobic Y, Paleiron N, Le Mao R, Joseph T, Hoffmann C, Dion A, Rousset J, Le Gal G, Lacut K, Leroyer C, Mottier D, Couturaud F. Patent Foramen Ovale and Ischemic Stroke in Patients With Pulmonary Embolism: A Prospective Cohort Study. Ann Intern Med. 2019 Jun 4;170(11):756-763. doi: 10.7326/M18-3485. Epub 2019 May 7.
- 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.
Emmanuelle LE MOIGNE, MD principal investigator
University Hospital, Brest
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recent Stroke and Pulmonary Embolism, run by University Hospital, Brest at 4 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of recent ischemic stroke in patients hospitalized for a recent pulmonary embolism with comparison in two groups with and without PFO (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01216423, which also lists 1 linked publication.
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 12 Jan 2017.