Ignite Creation Date:
2024-05-05 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00799565
Status:
COMPLETED
Last Update Posted:
2011-07-14
First Post:
2008-11-24
Brief Title:
Mitral Valve Prolapse MVP - France Study
Sponsor:
French Cardiology Society
Organization:
French Cardiology Society
Study Overview
Official Title:
Genetic Polymorphisms in Idiopathic Mitral Valve Prolapse A French Prospective Study Using a Genome Wide Analysis
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MVP-France
Brief Summary:
This prospective nation-wide France study aims to search for susceptibility genes in MVP using a genome wide analysis and comparing results obtained in 1000 patients with MVP and 1000 non-MVP subjects
Detailed Description:
Two MVP populations will be defined in that study either with the classical Barlow myxomatous disease or the fibroelastic degenerescence thin and redundant leaflets
MVP adult patients 18 year-old will be included if they present the following 1 or 2 criteria
1 2D-echocardiographic mitral leaflet prolapse on the parasternal long-axis view 2 mm AND leaflet thickness 4 mm or mitral regurgitation 2 using color Doppler
2 Previous surgery for pure severe mitral regurgitation due to MVP with Barlow disease or fibroelastic degenerescence with operative report available
Patients will be excluded in case of associated heart disease hypertrophic cardiomyopathy rheumatismal disease or syndromic disease Marfan Ehlers-Danlos
Around 30 cardiology cardiovascular surgery french centers will participate to this study An e-CRF will be used to collect clinical data A genetic core lab will collect the DNA samples An echocardiographic core lab will collect and read all the echo recordings
DNA analysis will be compared between the patient group and spouses of the patients used as controls In case of inadequacies concerning group size or age available genotyped cohorts will be used
MVP adult patients 18 year-old will be included if they present the following 1 or 2 criteria
1 2D-echocardiographic mitral leaflet prolapse on the parasternal long-axis view 2 mm AND leaflet thickness 4 mm or mitral regurgitation 2 using color Doppler
2 Previous surgery for pure severe mitral regurgitation due to MVP with Barlow disease or fibroelastic degenerescence with operative report available
Patients will be excluded in case of associated heart disease hypertrophic cardiomyopathy rheumatismal disease or syndromic disease Marfan Ehlers-Danlos
Around 30 cardiology cardiovascular surgery french centers will participate to this study An e-CRF will be used to collect clinical data A genetic core lab will collect the DNA samples An echocardiographic core lab will collect and read all the echo recordings
DNA analysis will be compared between the patient group and spouses of the patients used as controls In case of inadequacies concerning group size or age available genotyped cohorts will be used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None