Interest of Occlusion of Permeable Foramen Ovale After a Cryptogenic Cerebrovascular Accident (CVA) (FOPasa)

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. Identifier: NCT00872443
Recruitment Status : Completed
First Posted : March 31, 2009
Last Update Posted : April 28, 2010
Information provided by:
Nantes University Hospital

Brief Summary:

Facing the lack of recommandations of Neurology and cardiology societies, the investigators decided in 2002 some Good Medical Practices to define a specific and precise population for whom the closure of permeable oval formaen after a first CVA seem to be necessary. Current survey of these patients after implantation of a prothesis in interauricular septum is defined by a consultation at 1, 3 and 6 months after surgery for a clinical exam and an echocardiography. One year after implantation, the investigators systematically realized a control by MRI associated to a contrast echography.

In the aim of evaluating the investigators' medical practice, the investigators decided to do an observational study which will permit us to judge of the interest or lack of interest of our "Good medical practice" before the publication of prospective and randomised clinical studies.

Condition or disease Intervention/treatment
Permeable Foramen Ovale Cerebrovascular Accident Other: Data collection

Study Type : Observational
Actual Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Interest of Occlusion of Permeable Foramen Ovale After a Cryptogenic Cerebrovacular Accident.
Study Start Date : November 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Group/Cohort Intervention/treatment
Patients who already have an occlusion of POF secondary to a cryptogenic CVA and younger than 55 years old and without characterized thromboembolic events.
Other: Data collection

Collection of characteristics of interauricular septum, characteristics of the CVA, and headache history.

Collection of anamnesis data, surgical past history, especially at the moment of the implement of prothesis, collection of dtat of transthoracic echography, transcranial echodoppler, holter ECG, cerebral MRI.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patient who had an occlusion of POF after CVA, younger than 55 years and without thromboembolic events.

Inclusion Criteria:

  • less than 55 years old
  • occlusion of FOP after cryptogenic CVA

Exclusion Criteria:

  • characterized thromboembolic event
  • patients who have a surgery after transitory ischemic accident

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00872443

Nantes University Hospital
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital

Responsible Party: Dr Patrice Guerin, Nantes University Hospital Identifier: NCT00872443     History of Changes
Other Study ID Numbers: BRD 08/8-J
First Posted: March 31, 2009    Key Record Dates
Last Update Posted: April 28, 2010
Last Verified: April 2010

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases