Genetic of Aortic Valve Stenosis - Clinical and Therapeutic Implications (GENERAC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00647088
First received: March 26, 2008
Last updated: August 3, 2011
Last verified: June 2011

March 26, 2008
August 3, 2011
March 2008
March 2013   (final data collection date for primary outcome measure)
Identification of genetic polymorphisms of fetuin-A, matrix-GLA protein, vitamin D receptor [ Time Frame: end of the study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00647088 on ClinicalTrials.gov Archive Site
Identification of other genetic polymorphisms [ Time Frame: End of the Study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Genetic of Aortic Valve Stenosis - Clinical and Therapeutic Implications
Genetic of Aortic Valve Stenosis - Clinical and Therapeutic Implications

Pathophysiology of Aortic Valve Stenosis remains poorly known. The aim of the present study is to identify genetic factors involved in this disease using a case control trial design.

Aortic valve stenosis (AS) is the most common valvular disease and the second most common indication for cardiac surgery in Western countries. AS has long been considered as a passive and degenerative process. Recent data challenged this concept, showing that AS is an active and highly regulated process with some similarities to atherosclerosis. However, pathophysiology of AS remains poorly understood and preliminary data suggest that genetic factors may be involved. The aim of the present study is to identify genetic factors involved in this disease using a case control trial design (1000 patients with AS and 1500 controls with no evidence of valve disease). For all patients and controls, blood samples including DNA and echocardiography will be performed.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

blood samples DNA Tissue valve

Non-Probability Sample

case control study Case = patients with aortic valve stenosis Controls = participants free of aortic valve stenosis

Aortic Valve Stenosis
Not Provided
  • aortic stenosis
    various age and disease severity
  • Controls
    Controls free of valvular disease

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2200
March 2014
March 2013   (final data collection date for primary outcome measure)

Patients:

Inclusion criteria :

  • Age >=18 years
  • Pure isolated degenerative aortic valve stenosis

Exclusion criteria :

  • Rheumatic, congenital or post-radiation aortic stenosis
  • Severe renal insufficiency (clearance < 30 ml/min)
  • Aortic insufficiency > or = grade 2/4
  • Other valve disease > or = grade 2/4

Controls

Inclusion criteria :

- Age >=18 years

Exclusion criteria :

  • Known first degree relative with aortic valve stenosis
  • Severe renal insufficiency (clearance < 30 ml/min)
  • Any valve disease > or = grade 2/4
Both
18 Years and older
Yes
France
 
NCT00647088
P070141
Yes
Christophe Aucan, Department Clinical Research of Developpement
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator: David Messika-Zeitoun, MD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP