Aortic Valve Disease Clinical Trial
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
Verified date | February 2022 |
Source | Baylor Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | The Heart Hospital Baylor Plano | Plano | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor Research Institute |
United States,
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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