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

Cerebrovascular Accident Clinical Trial

— FOPasa  

Official title:

Interest of Occlusion of Permeable Foramen Ovale After a Cryptogenic Cerebrovacular Accident.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00872443
• Other study ID #: BRD 08/8-J
• Status: Completed
• Phase: N/A
• First received: March 30, 2009
• Last updated: April 27, 2010
• Start date: November 2008
• Est. completion date: April 2010

Study information

• Verified date: April 2010
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection AuthorityFrance: Institutional Ethical Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Permeable Foramen Ovale
• Stroke

Intervention

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.

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France,