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Pulmonary Embolism and Stroke in Patient With Patent Foramen Ovale (EPIC-FOP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT01216423
First received: September 29, 2010
Last updated: January 11, 2017
Last verified: January 2017

September 29, 2010
January 11, 2017
November 2009
December 2015   (Final data collection date for primary outcome measure)
Incidence of recent ischemic stroke in patients hospitalized for a recent pulmonary embolism with comparison in two groups with and without PFO [ Time Frame: 7 days ]
Same as current
Complete list of historical versions of study NCT01216423 on ClinicalTrials.gov Archive Site
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Pulmonary Embolism and Stroke in Patient With Patent Foramen Ovale
Is There a Link Between Venous Thromboembolism and Stroke in Patient With Patent Foramen Ovale ? Research for Stroke in Hospitalized Patients With Pulmonary Embolism.
The cause of ischemic stroke remains frequently unknown. In patients with patent foramen ovale (PFO), the link between PFO and Stroke is unclear. The investigators hypothesize that the main mechanism is paradoxical embolism and decided to look for clinically apparent and silent cerebral embolism in patients with a recent pulmonary embolism.

Inclusion criteria :

  • age > 18 years old
  • confirmed pulmonary embolism
  • informed consent
  • social ensured

Exclusion criteria :

  • pregnancy
  • age < 18 years old
  • protected major person (in sense of public health)
  • consent refused
  • MRI contraindications
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Consecutive series of hospitalized patients with pulmonary embolism
  • Recent Stroke
  • Pulmonary Embolism
  • Patent Foramen Ovale
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  • Incidence of recent stroke in patients with PFO
  • Incidence of recent stroke in patients without PFO
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
374
January 2017
December 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • age > 18 years old
  • confirmed pulmonary embolism
  • informed consent
  • social ensured

Exclusion Criteria:

  • pregnancy
  • age < 18 years old
  • protected major person (in sense of public health)
  • consent refused
  • MRI contraindications
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01216423
EPIC-FOP
Yes
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No
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University Hospital, Brest
University Hospital, Brest
Not Provided
Principal Investigator: Emmanuelle LE MOIGNE, MD University Hospital, Brest
University Hospital, Brest
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP