Pulmonary Embolism and Stroke in Patient With Patent Foramen Ovale
EPIC-FOP
Is There a Link Between Venous Thromboembolism and Stroke in Patient With Patent Foramen Ovale ? Research for Stroke in Hospitalized Patients With Pulmonary Embolism.
1 other identifier
observational
374
1 country
4
Brief 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 recent pulmonary embolism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2009
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 29, 2010
CompletedFirst Posted
Study publicly available on registry
October 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedJanuary 12, 2017
January 1, 2017
6.1 years
September 29, 2010
January 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of recent ischemic stroke in patients hospitalized for a recent pulmonary embolism with comparison in two groups with and without PFO
7 days
Study Arms (2)
Incidence of recent stroke in patients with PFO
Incidence of recent stroke in patients without PFO
Eligibility Criteria
Consecutive series of hospitalized patients with pulmonary embolism
You may qualify if:
- age \> 18 years old
- confirmed pulmonary embolism
- informed consent
- social ensured
You may not qualify if:
- pregnancy
- age \< 18 years old
- protected major person (in sense of public health)
- consent refused
- MRI contraindications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Army Hospital
Brest, France, 29200, France
CHU Dijon de Bocage
Dijon, France, 21079, France
Centre Hospitalier de Cornouaille
Quimper, France, 29107, France
Brest University Hospital
Brest, 29 609, France
Related Publications (1)
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.
PMID: 31060047DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emmanuelle LE MOIGNE, MD
University Hospital, Brest
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2010
First Posted
October 7, 2010
Study Start
November 1, 2009
Primary Completion
December 1, 2015
Study Completion
January 1, 2017
Last Updated
January 12, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share