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

This study has been terminated.
(The study stooped because the answer to the primary objective is possible.)
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT01216423
First received: September 29, 2010
Last updated: March 22, 2016
Last verified: March 2016
  Purpose
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.

Condition
Recent Stroke
Pulmonary Embolism
Patent Foramen Ovale

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is There a Link Between Venous Thromboembolism and Stroke in Patient With Patent Foramen Ovale ? Research for Stroke in Hospitalized Patients With Pulmonary Embolism.

Resource links provided by NLM:


Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 313
Study Start Date: November 2009
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Incidence of recent stroke in patients with PFO
Incidence of recent stroke in patients without PFO

Detailed Description:

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive series of hospitalized patients with pulmonary embolism
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01216423

Locations
France
Brest University Hospital
Brest, France, 29 609
Army Hospital
Brest, France, 29200
CHU Dijon de Bocage
Dijon, France, 21079
Centre Hospitalier de Cornouaille
Quimper, France, 29107
Sponsors and Collaborators
University Hospital, Brest
Investigators
Principal Investigator: Emmanuelle LE MOIGNE, MD University Hospital, Brest
  More Information

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT01216423     History of Changes
Other Study ID Numbers: EPIC-FOP 
Study First Received: September 29, 2010
Last Updated: March 22, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Brest:
Patent Foramen Ovale
Pulmonary embolism
Stroke

Additional relevant MeSH terms:
Embolism
Foramen Ovale, Patent
Pulmonary Embolism
Stroke
Brain Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Congenital Abnormalities
Embolism and Thrombosis
Heart Defects, Congenital
Heart Diseases
Heart Septal Defects
Heart Septal Defects, Atrial
Lung Diseases
Nervous System Diseases
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 04, 2016