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

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

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:

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)
Incidence of silent stroke in patients with PFO
Incidence of silent stroke in patients without PFO


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

Inclusion Criteria:

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

Exclusion Criteria:

  • contra-indication to MRI, informed consent not obtained
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00831259

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

Keywords provided by University Hospital, Caen:

Additional relevant MeSH terms:
Foramen Ovale, Patent
Pulmonary Embolism
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Embolism and Thrombosis
Heart Defects, Congenital
Heart Diseases
Heart Septal Defects
Heart Septal Defects, Atrial
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 25, 2016