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NCT00831259 Clinical Trial

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

Pulmonary Embolism Clinical Trial

— ICEP  

Official title:
Silent Cerebral Infarcts in Patients With Pulmonary Embolism and a Patent Foramen Ovale: a Prospective Diffusion-weighted Magnetic Resonance Imaging Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00831259
Other study ID # CHU de Caen
Secondary ID
Status Completed
Phase N/A
First received January 27, 2009
Last updated May 19, 2011
Start date October 2007
Est. completion date May 2009

Study information
Verified date May 2011
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date May 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- contra-indication to MRI, informed consent not obtained

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France USIC CHU de Caen Caen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of cerebral infarcts as detected by Diffusion-weighted MRI during hospitalization Yes
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