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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01216423
Recruitment Status : Completed
First Posted : October 7, 2010
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Tracking Information
First Submitted Date September 29, 2010
First Posted Date October 7, 2010
Last Update Posted Date January 12, 2017
Study Start Date November 2009
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 6, 2010)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pulmonary Embolism and Stroke in Patient With Patent Foramen Ovale
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.
Brief Summary 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.
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Consecutive series of hospitalized patients with pulmonary embolism
Condition
  • Recent Stroke
  • Pulmonary Embolism
  • Patent Foramen Ovale
Intervention Not Provided
Study Groups/Cohorts
  • Incidence of recent stroke in patients with PFO
  • Incidence of recent stroke in patients without PFO
Publications * Le Moigne E, Timsit S, Ben Salem D, Didier R, Jobic Y, Paleiron N, Le Mao R, Joseph T, Hoffmann C, Dion A, Rousset J, Le Gal G, Lacut K, Leroyer C, Mottier D, Couturaud F. Patent Foramen Ovale and Ischemic Stroke in Patients With Pulmonary Embolism: A Prospective Cohort Study. Ann Intern Med. 2019 Jun 4;170(11):756-763. doi: 10.7326/M18-3485. Epub 2019 May 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 11, 2017)
374
Original Estimated Enrollment
 (submitted: October 6, 2010)
297
Actual Study Completion Date January 2017
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01216423
Other Study ID Numbers EPIC-FOP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Brest
Study Sponsor University Hospital, Brest
Collaborators Not Provided
Investigators
Principal Investigator: Emmanuelle LE MOIGNE, MD University Hospital, Brest
PRS Account University Hospital, Brest
Verification Date January 2017