A Study to Identify Differences in Gene Expression in Patients With Bicuspid and Tricuspid Valve Disease
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|ClinicalTrials.gov Identifier: NCT01194362|
Recruitment Status : Active, not recruiting
First Posted : September 3, 2010
Last Update Posted : July 13, 2017
|Condition or disease|
|Aortic Valve Disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||105 participants|
|Official Title:||A Study to Establish Genomic Bio Signatures of Ascending Aortic Aneurysms in Patients With Bicuspid and Tricuspid Aortic Valve Disease With Aortic Stenosis|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
|45 specimens collected from BAV patients|
|45 specimens collected from TAV patients|
|15 specimens collected from CABG pts|
- Determine differences in genetic expression profiles using mRNA transcriptional analysis [ Time Frame: 12 month ]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 the association between genetic expression profiles and aortic dilation in the two aortic valve disease groups. [ Time Frame: 12 months ]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 ]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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01194362
|United States, Texas|
|The Heart Hospital Baylor Plano|
|Plano, Texas, United States, 75093|
|Principal Investigator:||William Brinkman, MD||The Heart Hospital Baylor Plano|