Interest of Occlusion of Permeable Foramen Ovale After a Cryptogenic Cerebrovascular Accident (CVA) - Full Text View

Sponsor:	Nantes University Hospital
Information provided by:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT00872443

Purpose

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	Intervention
Permeable Foramen Ovale Cerebrovascular Accident	Other: Data collection

Study Type:	Observational
Study Design:	Cohort, Retrospective
Official Title:	Interest of Occlusion of Permeable Foramen Ovale After a Cryptogenic Cerebrovacular Accident.

Further study details as provided by Nantes University Hospital:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	November 2008

Groups/Cohorts	Assigned Interventions
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.	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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
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.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872443

Contacts

Contact: Patrice Guérin, MD

0240087868

patrice.guerin@chu-nantes.fr

Locations

France
Nantes University Hospital	Recruiting
Nantes, France, 44093
Contact: Patrice Guerin, MD 0240087868 patrice.guerin@chu-nantes.fr
Principal Investigator: Patrice Guérin, MD

Sponsors and Collaborators

Nantes University Hospital

More Information

No publications provided

Responsible Party:	Nantes University Hospital ( Dr Patrice Guerin )
Study ID Numbers:	BRD 08/8-J
Study First Received:	March 30, 2009
Last Updated:	March 30, 2009
ClinicalTrials.gov Identifier:	NCT00872443 History of Changes
Health Authority:	France: French Data Protection Authority; France: Institutional Ethical Committee

Additional relevant MeSH terms:

Cerebral Infarction
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases

Brain Ischemia
Cardiovascular Diseases
Brain Infarction
Brain Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on February 09, 2010