Aortic Valve Disease Clinical Trial
Official title:
Identification of Genetic Causes of Calcific Aortic Valve Disease
This study aims to identify the molecular genetic causes of the variability in development of calcific aortic valve disease in bicuspid and tricuspid aortic valves and their associated aortic dilation.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | June 30, 2027 |
Est. primary completion date | June 30, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: - Patients with a plan to undergo elective aortic valve replacement and/or ascending aortic surgery Exclusion Criteria: - Age < 20 years - Unable/unwilling to consent - History of aortic valve replacement or transcatheter aortic valve replacement (TAVR) - History of endocarditis - History of rheumatic fever - History of chest radiotherapy - History of organ transplant |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center | Brigham and Women's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identification of expression signatures of aortic valve development and calcification in the macroscopically normal and abnormal portions of aortic valves excised during aortic valve replacement. | We will take a portion of the aortic valve and/or aortic tissue that is routinely excised for aortic valve or aortic replacement for expression analyses and generation of fibroblast cell lines. In collaboration with the Department of Pathology, we have established methods to take sufficient "normal" and abnormal tissue while allowing formal routine pathological evaluation.
All tissue samples for expression analysis will be transported in iced RNALater and later frozen in a -80°C research freezer, prior to next generation sequencing. We may use tissue samples to develop cell lines for indefinite use. |
8 years |
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