This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
University Hospital, Caen 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 ]

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   (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

Inclusion Criteria:

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

Exclusion Criteria:

  • contra-indication to MRI, informed consent not obtained
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its 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 Identifier: NCT00831259     History of Changes
Other Study ID Numbers: CHU de Caen
Study First Received: January 27, 2009
Last Updated: May 19, 2011

Keywords provided by University Hospital, Caen:

Additional relevant MeSH terms:
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 processed this record on September 21, 2017