- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00831259
Risk of Stroke in Pulmonary Embolism With a Patent Foramen Ovale (PFO) (ICEP)
May 19, 2011 updated by: University Hospital, Caen
Silent Cerebral Infarcts in Patients With Pulmonary Embolism and a Patent Foramen Ovale: a Prospective Diffusion-weighted Magnetic Resonance Imaging Study.
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Caen, France, 14033
- USIC CHU de Caen
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Consecutive series of patients with a pulmonary embolism
Description
Inclusion Criteria:
- Pulmonary embolism, informed consent signed, no-contraindication to MRI
Exclusion Criteria:
- contra-indication to MRI, informed consent not obtained
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
Incidence of silent stroke in patients with PFO
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2
Incidence of silent stroke in patients without PFO
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of cerebral infarcts as detected by Diffusion-weighted MRI
Time Frame: during hospitalization
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during hospitalization
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
January 27, 2009
First Submitted That Met QC Criteria
January 27, 2009
First Posted (Estimate)
January 28, 2009
Study Record Updates
Last Update Posted (Estimate)
May 20, 2011
Last Update Submitted That Met QC Criteria
May 19, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Congenital Abnormalities
- Embolism and Thrombosis
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Heart Septal Defects, Atrial
- Heart Septal Defects
- Stroke
- Embolism
- Foramen Ovale, Patent
- Pulmonary Embolism
Other Study ID Numbers
- CHU de Caen
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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