Identification of Genetic Mechanisms of Bicuspid Aortic Valve Disease (BAV Genetics)
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Purpose
BAVgenetics is a partnership between Investigators at Brigham and Women's Hospital, Massachusetts General Hospital and the Harvard-Partners Center for Genetics and Genomics, dedicated to discovering the genetic causes of bicuspid aortic valve disease and associated aortic disease.
The Investigators at BAVgenetics are dedicated to discovering the mechanisms of bicuspid aortic valve disease and why individual genetics seem to play such an important role in generation of this disease.
If you have, or have had, a bicuspid aortic valve, we seek your help in this effort by volunteering to donate DNA and details of your disease to the Investigators, so that this disease can be better understood and therapies for it can be developed.
| Condition |
|---|
|
Bicuspid Aortic Valve |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Identification of Genetic Mechanisms of Bicuspid Aortic Valve Disease |
- Identification of genetic variants associated with the occurrence of bicuspid aortic valve disease [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Collection of salivary DNA
| Estimated Enrollment: | 4000 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | December 2019 |
| Estimated Primary Completion Date: | December 2019 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Bicuspid aortic valve
Collection of patients who are known to have bicuspid aortic valve disease, diagnosed by prior cardiac imaging
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
The investigators wish to identify genetic variation that is associated with BAV in Americans.
Patients with a diagnosis of bicuspid aortic valve will be enrolled. Patients who have had their bicuspid aortic valve previously replaced will also be enrolled.
Inclusion Criteria:
- Any adult patient ≥ 18 years of age may be recruited regardless of gender, ethnicity or racial group.
- Patients with a diagnosis of bicuspid aortic valve will be enrolled.
- Patients who have had their bicuspid aortic valve previously replaced will also be enrolled.
Exclusion Criteria:
- None
Contacts and Locations| Contact: Simon C Body, MBChB, MPH | 617-732-7330 | body@zeus.bwh.harvard.edu |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: | Simon C Body, MBChB, MPH | Brigham and Women's Hospital |
| Principal Investigator: | Christine E Seidman, MD | Brigham and Women's Hospital |
| Principal Investigator: | Jon G Seidman, PhD | Harvard Partners Center for Genetics and Genomics |
| Principal Investigator: | Robert Levine, MD | Massachusetts General Hospital |
| Principal Investigator: | Eric M Isselbacher, MD | Massachusetts General Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Simon Body, Associate Professor, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT01026571 History of Changes |
| Other Study ID Numbers: | 2009P001639 |
| Study First Received: | December 3, 2009 |
| Last Updated: | December 31, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Brigham and Women's Hospital:
|
Bicuspid aortic valve |
ClinicalTrials.gov processed this record on May 19, 2013