Aortic Valve Disease Clinical Trial
— TAAOfficial title:
Pathogenetic Basis of Aortopathy and Aortic Valve Disease
The main purpose of this study is to define the complex genetic and pathogenic basis of thoracic aortic aneurysm (TAA) and other forms of aortopathy and/or aortic valve disease by identifying novel disease-causing genes and by identifying important genetic modifiers for aortic and aortic valve disease severity.
Status | Recruiting |
Enrollment | 3000 |
Est. completion date | December 31, 2030 |
Est. primary completion date | December 31, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Open to external enrollment: - Subjects with a genetic diagnosis of Marfan Syndrome (MDS), Loeys-Dietz Syndrome (LDS), or Vascular Ehlers-Danlos Syndrome (EDS); (Positive genetic testing or a previous cardiac study required to be eligible) - Family members of eligible subjects (Only family members of subjects with syndromic diagnoses are eligible for external enrollment at this time) - Closed to external enrollment: - Subjects with aortic disease including TAA* or dissection, aortic tortuosity, or aortic hypoplasia/stenosis (based on any cardiac imaging modality including echocardiography, CT, MRI, or angiography) - Subjects with aortic valve disease (bicuspid, unicuspid, or tricuspid disease) - Control subjects having tissue removed during a surgical procedure (e.g. coronary artery bypass graft surgery (CABG), cardiac transplant, etc.) Exclusion Criteria: • Inability or unwillingness to provide consent (assent when indicated) |
Country | Name | City | State |
---|---|---|---|
United States | Childrens Healthcare of Atlanta | Atlanta | Georgia |
United States | IU School of Medicine | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Biorepository Establishment | Establish a biorepository with detailed phenotype information to facilitate a broad spectrum of current and future studies | 20 years | |
Primary | Genetic Analysis | The mechanisms of TAA pathogenesis will be determined by studying explanted aortic tissue and cells derived from patients with TAA for gene expression, protein expression, and other functional assays. | 20 years |
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