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

This study is currently recruiting participants.
Verified May 2013 by University Hospital, Brest
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT01216423
First received: September 29, 2010
Last updated: May 16, 2013
Last verified: May 2013
History of Changes
  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:

U.S. FDA Resources

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 2013
Estimated Primary Completion Date: December 2013 (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
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
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            
Army Hospital Recruiting
Brest, France, 29200
Contact: Nicolas Paleiron, MD         nicolas.paleiron@free.fr    
Principal Investigator: Nicolas Paleiron, MD            
CHU Dijon de Bocage Recruiting
Dijon, France, 21079
Contact: Bernard Lorcerie, PH            
Principal Investigator: Bernard Lorcerie            
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: May 16, 2013
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
Heart Septal Defects, Atrial
Pulmonary Embolism
Stroke
Cerebral Infarction
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
 Heart Diseases
Congenital Abnormalities
Lung Diseases
Respiratory Tract Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Infarction
Brain Ischemia
Thromboembolism
Thrombosis

ClinicalTrials.gov processed this record on May 16, 2013