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A Study to Identify Differences in Gene Expression in Patients With Bicuspid and Tricuspid Valve Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Baylor Research Institute
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT01194362
First received: September 1, 2010
Last updated: March 3, 2014
Last verified: March 2014

September 1, 2010
March 3, 2014
September 2010
September 2014   (final data collection date for primary outcome measure)
Determine differences in genetic expression profiles using mRNA transcriptional analysis [ Time Frame: 12 month ] [ Designated as safety issue: No ]
Determine differences in genetic expression profiles using mRNA transcriptional analysis in the three groups: subjects with bicuspid aortic valves with aortic stenosis, subjects with tricuspid aortic valves with stenosis, and subjects without aortic valve disease.
Determine differences in genetic expression profiles using mRNA transcriptional analysis [ Time Frame: 12 month ] [ Designated as safety issue: No ]
Determine differences in genetic expression profiles using mRNA transcriptional analysis among: subjects with bicuspid aortic valves with aortic stenosis, subjects with tricuspid aortic valves with aortic stenosis, and subjects with no aortic valve diseas
Complete list of historical versions of study NCT01194362 on ClinicalTrials.gov Archive Site
  • Determine differences in the association between genetic expression profiles and aortic dilation in the two aortic valve disease groups. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Determine differences in the association between genetic expression profiles and aortic dilation (in cm) among: subjects with bicuspid aortic valves and subjects with tricuspid aortic valves with aortic stenosis.
  • Determine the association between expression of inflammatory markers/impaired response to oxidative stress and stenotic aortic valve disease. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Determine differences between expression of inflammatory markers/impaired response to oxidative stress and stenotic aortic valve disease among: subjects with bicuspid aortic valves and subjects with tricuspid aortic valves with aortic stenosis.
Determine differences in the association between genetic expression profiles and aortic dilation (in cm) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Determine differences in the association between genetic expression profiles and aortic dilation (in cm) among: subjects with bicuspid aortic valves and subjects with tricuspid aortic valves with aortic stenosis. Determine the association between expressi
Not Provided
Not Provided
 
A Study to Identify Differences in Gene Expression in Patients With Bicuspid and Tricuspid Valve Disease
A Study to Establish Genomic Bio Signatures of Ascending Aortic Aneurysms in Patients With Bicuspid and Tricuspid Aortic Valve Disease With Aortic Stenosis

For this study, blood and tissue samples will be collected in order to perform genetic testing to help researchers gather information about this disease and how and why it affects some patients more than others.

The cause of bicuspid aortic valve (BAV) and its associated co morbidities is unknown. There is, however, evidence supporting a genetic cause for the BAV, Pedigree analysis of familial clustering initially directed investigators to a genetic cause of BAV. Subsequent studies on BAV patients using linkage analysis have demonstrated high heritability.

Early identification of those patients with BAV disease who are at risk for ascending aneurysm formation and its complications may allow early intervention to prevent rupture, dissection and emergent cardiac surgery in at risk patients. Conversely, identification of those patients with BAVs not at risk for aortic aneurysm formation would delineate which patients do not need close follow up of aortic size or prophylactic ascending aortic replacement at time of aortic valve replacement.

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

Blood and Tissue

Probability Sample

Hospital facility

Aortic Valve Disease
Not Provided
  • 45 specimens collected from BAV patients
  • 45 specimens collected from TAV patients
  • 15 specimens collected from CABG pts
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
105
September 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients > or = to 18 years of age
  • Presenting with aortic stenosis and to undergo elective aortic valve replacement or repair with or without aortic aneurysm dilation repair
  • Able to sign informed consent document

Exclusion Criteria:

  • Patients unable to provide informed consent for any reason
  • Patients with predominant aortic regurgitation valve disease
  • Patients with other known connective tissue disorders (such as Marfan's Syndrome, Ehlers-Danlos Syndrome)
Both
18 Years and older
No
Contact: Geoffrey Gong 469-814-4732 gang.gong@baylorhealth.edu
United States
 
NCT01194362
010-161
No
Baylor Research Institute
Baylor Research Institute
Not Provided
Principal Investigator: William Brinkman, MD The Heart Hospital Baylor Plano
Baylor Research Institute
March 2014

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