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

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.

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Key information

Conditions

Silent Stroke Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Embolism Embolism and Thrombosis Foramen Ovale, Patent Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial Lung Diseases Nervous System Diseases Patent Foramen Ovale Pulmonary Embolism Respiratory Tract Diseases Stroke Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

USIC CHU de Caen

Caen, 14033, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

contra-indication to MRI, informed consent not obtained

Treatment and study plan

Primary outcomes

Incidence of cerebral infarcts as detected by Diffusion-weighted MRI

Time frame: during hospitalization

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Acronym: ICEP

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Jan 28, 2009
Registry last updated: May 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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