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

This study has been completed.

Sponsor:

Information provided by:

Nantes University Hospital

ClinicalTrials.gov Identifier:

NCT00872443

First received: March 30, 2009

Last updated: April 27, 2010

Last verified: April 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	March 30, 2009
Last Updated Date	April 27, 2010
Start Date ^ICMJE	November 2008
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00872443 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Interest of Occlusion of Permeable Foramen Ovale After a Cryptogenic Cerebrovascular Accident (CVA)
Official Title ^ICMJE	Interest of Occlusion of Permeable Foramen Ovale After a Cryptogenic Cerebrovacular Accident.
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	patient who had an occlusion of POF after CVA, younger than 55 years and without thromboembolic events.
Condition ^ICMJE	Permeable Foramen Ovale Cerebrovascular Accident
Intervention ^ICMJE	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. Other Name: Data collection
Study Group/Cohort (s)	FOP Patients who already have an occlusion of POF secondary to a cryptogenic CVA and younger than 55 years old and without characterized thromboembolic events. Intervention: Other: Data collection
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	72
Completion Date	April 2010
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 55 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT00872443
Other Study ID Numbers ^ICMJE	BRD 08/8-J
Has Data Monitoring Committee	No
Responsible Party	Dr Patrice Guerin, Nantes University Hospital
Study Sponsor ^ICMJE	Nantes University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Nantes University Hospital
Verification Date	April 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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