Pulmonary Embolism and Stroke in Patient With Patent Foramen Ovale (EPIC-FOP)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01216423 |
Recruitment Status :
Completed
First Posted : October 7, 2010
Last Update Posted : January 12, 2017
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Condition or disease |
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Recent Stroke Pulmonary Embolism Patent Foramen Ovale |
Study Type : | Observational |
Actual Enrollment : | 374 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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. |
Study Start Date : | November 2009 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | January 2017 |

Group/Cohort |
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Incidence of recent stroke in patients with PFO |
Incidence of recent stroke in patients without PFO |
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01216423
France | |
Brest University Hospital | |
Brest, France, 29 609 | |
Army Hospital | |
Brest, France, 29200 | |
CHU Dijon de Bocage | |
Dijon, France, 21079 | |
Centre Hospitalier de Cornouaille | |
Quimper, France, 29107 |
Principal Investigator: | Emmanuelle LE MOIGNE, MD | University Hospital, Brest |
Responsible Party: | University Hospital, Brest |
ClinicalTrials.gov Identifier: | NCT01216423 |
Other Study ID Numbers: |
EPIC-FOP |
First Posted: | October 7, 2010 Key Record Dates |
Last Update Posted: | January 12, 2017 |
Last Verified: | January 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Patent Foramen Ovale Pulmonary embolism Stroke |
Pulmonary Embolism Stroke Embolism Foramen Ovale, Patent Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Heart Septal Defects, Atrial Heart Septal Defects Heart Defects, Congenital Cardiovascular Abnormalities Heart Diseases Congenital Abnormalities |