Pulmonary Embolism and Stroke in Patient With Patent Foramen Ovale (EPIC-FOP)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified January 2015 by University Hospital, Brest
Sponsor:
University Hospital, Brest
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT01216423
First received: September 29, 2010
Last updated: January 26, 2015
Last verified: January 2015
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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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 297 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | November 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 |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01216423
Please refer to this study by its ClinicalTrials.gov identifier: NCT01216423
Contacts
| Contact: Emmanuelle Le Moigne, MD | +33298347336 | emmanuelle.lemoigne@chu-brest.fr |
Locations
| France | |
| Army Hospital | Recruiting |
| Brest, France, 29200 | |
| Contact: Nicolas Paleiron, MD nicolas.paleiron@free.fr | |
| Principal Investigator: Nicolas Paleiron, MD | |
| Brest University Hospital | Recruiting |
| Brest, France, 29 609 | |
| Contact: Emmanuelle Le Moigne, MD +33 2 98 34 73 36 emmanuelle.lemoigne@chu-brest.fr | |
| Principal Investigator: Emmanuelle Le Moigne, MD | |
| CHU Dijon de Bocage | Recruiting |
| Dijon, France, 21079 | |
| Contact: Bernard Lorcerie, PH | |
| Principal Investigator: Bernard Lorcerie | |
| CHU Saint-Etienne | Not yet recruiting |
| Saint-Etienne, France, 45055 | |
| Contact: Laurent BERTOLETTI, PH | |
| Principal Investigator: Laurent BERTOLETTI, PH | |
Sponsors and Collaborators
University Hospital, Brest
Investigators
| Principal Investigator: | Emmanuelle LE MOIGNE, MD | University Hospital, Brest |
More Information
No publications provided
| 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 26, 2015 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Brest:
|
Patent Foramen Ovale Pulmonary embolism Stroke |
Additional relevant MeSH terms:
|
Embolism Foramen Ovale, Patent Pulmonary Embolism Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Embolism and Thrombosis |
Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial Lung Diseases Respiratory Tract Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on March 03, 2015