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Genetic Test Based Risk Prediction of Early Calcific Aortic Valve Disease in Patients With Bicuspid Aortic Valve
Sponsor: Yonsei University
Summary
This study is to elucidate the impact of germline mutations and clonal hematopoiesis (CHIP) on the progression of early aortic valve calcification in patients with bicuspid aortic valves. The study will be conducted over a recruitment period of one year and a follow-up observation period of two years. Considering a 2-year event rate and a 33% occurrence rate of clonal hematopoiesis, each group requires a minimum of 102 participants. Accounting for a 15% dropout rate, a total of 120 participants are needed for each group (type I error (α) = 5%, type II error (β) = 20%). Therefore, the total study population, including patients with normal aortic valve function, is set at 240 participants.
Key Details
Gender
All
Age Range
19 Years - 80 Years
Study Type
OBSERVATIONAL
Enrollment
240
Start Date
2023-10-19
Completion Date
2028-10
Last Updated
2023-12-01
Healthy Volunteers
No
Conditions
Locations (1)
Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine
Seoul, South Korea