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Pulmonary Embolism and Stroke in Patient With Patent Foramen Ovale (EPIC-FOP)

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
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Recent Stroke Pulmonary Embolism Patent Foramen Ovale

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

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
Primary Completion Date : December 2015
Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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


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
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

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