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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01194362
Other study ID # 010-161
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 2010
Est. completion date December 2022

Study information

Verified date February 2022
Source Baylor Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 105
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Locations

Country Name City State
United States The Heart Hospital Baylor Plano Plano Texas

Sponsors (1)

Lead Sponsor Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determine differences in genetic expression profiles using mRNA transcriptional analysis 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. 12 month
Secondary Determine differences in the association between genetic expression profiles and aortic dilation in the two aortic valve disease groups. 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. 12 months
Secondary Determine the association between expression of inflammatory markers/impaired response to oxidative stress and stenotic aortic valve disease. 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. 12 months
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