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Risk of Stroke in Pulmonary Embolism With a Patent Foramen Ovale (PFO) (ICEP)

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: NCT00831259
Recruitment Status : Completed
First Posted : January 28, 2009
Last Update Posted : May 20, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
Pulmonary embolism is associated with a small but definite risk of paradoxical embolism in patients with a patent foramen ovale (PFO). While neurologic complications are unfrequent the incidence of clinically silent brain infarction is unknown. We will assess the rate of clinically apparent and silent cerebral embolism in patients with a pulmonary embolism (PE) in relation to the presence or not of a PFO.

Condition or disease
Silent Stroke Pulmonary Embolism Patent Foramen Ovale

Study Design

Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Silent Cerebral Infarcts in Patients With Pulmonary Embolism and a Patent Foramen Ovale: a Prospective Diffusion-weighted Magnetic Resonance Imaging Study.
Study Start Date : October 2007
Primary Completion Date : April 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
1
Incidence of silent stroke in patients with PFO
2
Incidence of silent stroke in patients without PFO


Outcome Measures

Primary Outcome Measures :
  1. Incidence of cerebral infarcts as detected by Diffusion-weighted MRI [ Time Frame: during hospitalization ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive series of patients with a pulmonary embolism
Criteria

Inclusion Criteria:

  • Pulmonary embolism, informed consent signed, no-contraindication to MRI

Exclusion Criteria:

  • contra-indication to MRI, informed consent not obtained
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): NCT00831259


Locations
France
USIC CHU de Caen
Caen, France, 14033
Sponsors and Collaborators
University Hospital, Caen
More Information

Responsible Party: Patrick MICHEL, research and strategy manager, CHU de CAEN
ClinicalTrials.gov Identifier: NCT00831259     History of Changes
Other Study ID Numbers: CHU de Caen
First Posted: January 28, 2009    Key Record Dates
Last Update Posted: May 20, 2011
Last Verified: May 2011

Keywords provided by University Hospital, Caen:
stroke
PFO
embolism

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