Pulmonary Embolism and Stroke in Patient With Patent Foramen Ovale (EPIC-FOP)
This study has been completed.
Sponsor:
University Hospital, Brest
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT01216423
First received: September 29, 2010
Last updated: January 11, 2017
Last verified: January 2017
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Purpose
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.
| Condition |
|---|
|
Recent Stroke Pulmonary Embolism Patent Foramen Ovale |
| Study Type: | Observational |
| Study Design: | 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. |
Resource links provided by NLM:
Further study details as provided by University Hospital, Brest:
Primary Outcome Measures:
- 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 ]
| Enrollment: | 374 |
| Study Start Date: | November 2009 |
| Study Completion Date: | January 2017 |
| Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Incidence of recent stroke in patients with PFO |
| Incidence of recent stroke in patients without PFO |
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
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Consecutive series of hospitalized patients with pulmonary embolism
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01216423
Please refer to this study by its ClinicalTrials.gov identifier: NCT01216423
Locations
| 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 | |
Sponsors and Collaborators
University Hospital, Brest
Investigators
| Principal Investigator: | Emmanuelle LE MOIGNE, MD | University Hospital, Brest |
More Information
| Responsible Party: | University Hospital, Brest |
| ClinicalTrials.gov Identifier: | NCT01216423 History of Changes |
| Other Study ID Numbers: |
EPIC-FOP |
| Study First Received: | September 29, 2010 |
| Last Updated: | January 11, 2017 |
| Individual Participant Data | |
| Plan to Share IPD: | No |
Keywords provided by University Hospital, Brest:
|
Patent Foramen Ovale Pulmonary embolism Stroke |
Additional relevant MeSH terms:
|
Stroke Embolism Pulmonary 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 |
ClinicalTrials.gov processed this record on May 22, 2017