Risk of Stroke in Pulmonary Embolism With a Patent Foramen Ovale (PFO) - Full Text View

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

This study is currently recruiting participants.

Verified by University Hospital, Caen, January 2009

First Received: January 27, 2009 No Changes Posted

Sponsored by:	University Hospital, Caen
Information provided by:	University Hospital, Caen
ClinicalTrials.gov Identifier:	NCT00831259

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

MedlinePlus related topics: Pulmonary Embolism

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Silent Cerebral Infarcts in Patients With Pulmonary Embolism and a Patent Foramen Ovale: a Prospective Diffusion-Weighted Magnetic Resonance Imaging Study.

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	70
Study Start Date:	October 2007
Estimated Study Completion Date:	April 2009
Estimated 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	Recruiting
Caen, France, 14033
Contact: Martial HAMON, MD +33231065119 hamon-m@chu-caen.fr
Principal Investigator: Martial HAMON, MD

Sponsors and Collaborators

University Hospital, Caen

More Information

No publications provided

Responsible Party:	CHU de CAEN ( Patrick MICHEL, research and strategy manager )
Study ID Numbers:	CHU de Caen
Study First Received:	January 27, 2009
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00831259 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Caen:

stroke
PFO
embolism

Study placed in the following topic categories:

Heart Septal Defects
Heart Diseases
Pulmonary Embolism
Cerebral Infarction
Cardiovascular Abnormalities
Stroke
Vascular Diseases
Central Nervous System Diseases
Brain Diseases
Cerebrovascular Disorders
Thrombosis

Heart Septal Defects, Atrial
Embolism and Thrombosis
Respiratory Tract Diseases
Embolism
Foramen Ovale, Patent
Lung Diseases
Congenital Heart Septum Defect
Congenital Abnormalities
Infarction
Heart Defects, Congenital

Additional relevant MeSH terms:

Heart Septal Defects
Pulmonary Embolism
Heart Diseases
Cardiovascular Abnormalities
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases
Brain Diseases
Cerebrovascular Disorders

Heart Septal Defects, Atrial
Embolism and Thrombosis
Respiratory Tract Diseases
Embolism
Foramen Ovale, Patent
Lung Diseases
Cardiovascular Diseases
Congenital Abnormalities
Heart Defects, Congenital

ClinicalTrials.gov processed this record on May 06, 2009