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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT00831259
First received: January 27, 2009
Last updated: May 19, 2011
Last verified: May 2011
History of Changes
  Purpose

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
Silent Stroke
Pulmonary Embolism
Patent Foramen Ovale

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • Incidence of cerebral infarcts as detected by Diffusion-weighted MRI [ Time Frame: during hospitalization ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: October 2007
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Incidence of silent stroke in patients with PFO
2
Incidence of silent stroke in patients without PFO

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00831259

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

No publications provided

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
Study First Received: January 27, 2009
Last Updated: May 19, 2011
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Caen:
stroke
PFO
embolism

Additional relevant MeSH terms:
Embolism
Foramen Ovale, Patent
Heart Septal Defects, Atrial
Pulmonary Embolism
Stroke
Cerebral Infarction
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

ClinicalTrials.gov processed this record on June 18, 2013