Actively Recruiting
Genetic Test Based Risk Prediction of Early Calcific Aortic Valve Disease in Patients With Bicuspid Aortic Valve
Led by Yonsei University · Updated on 2023-12-01
240
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how genetic mutations and clonal hematopoiesis (CHIP) affect the early development of calcification in the aortic valve among patients with bicuspid aortic valves. This observational study aims to understand the progression of early aortic valve calcification by monitoring a total of 240 participants, including those with normal and abnormal valve function. The study is sponsored by Yonsei University and involves a recruitment period of one year followed by two years of follow-up observation. Participants will be divided into groups based on their valve function: those with moderate or greater aortic valve stenosis or regurgitation and those with mild or less valve dysfunction. The study does not involve any treatment but focuses on genetic testing and monitoring of valve changes. The total sample includes patients aged between 20 and 80 years, with careful attention to the presence of germline mutations and CHIP mutations over the two-year follow-up. During the study, participants will undergo cardiac imaging and genetic assessments to identify mutations and track the progression of valve calcification. Researchers will observe the presence of germline and CHIP mutations as the primary outcomes, and the progression of aortic valve calcification as a secondary outcome over two years. The study also includes ongoing safety monitoring and data collection to understand the genetic risk factors impacting valve disease progression.
CONDITIONS
Brief Title
Genetic Test Based Risk Prediction of Early Calcific Aortic Valve Disease in Patients With Bicuspid Aortic Valve
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with confirmed bicuspid aortic valves based on cardiac imaging or surgical findings
- Patients aged 20 to 80 with moderate or greater aortic valve stenosis or regurgitation (early calcification group)
- Patients aged 20 to 80 with mild or less aortic valve stenosis or regurgitation (normal functioning valve group)
- Patients who understand the study purpose and voluntarily consent to participate
You will not qualify if you...
- Patients with malignant neoplastic diseases or conditions predicting survival less than 6 months
- Patients with unclear presence of bicuspid aortic valves
- Patients with stage 3 or higher chronic kidney disease
- Patients with other inherited cardiac conditions
- Patients with cognitive impairment or hemodynamically unstable who have difficulty understanding the study content
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Initial assessment period
Participants undergo genetic testing and cardiac imaging to assess aortic valve condition and mutations.
1 visit (in-person)
Duration - 2 years
Participants are monitored over 2 years to observe the presence of genetic mutations and progression of aortic valve calcification.
Follow-up visits during 2-year period
Trial Site Locations
Total: 1 location
1
Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine
Seoul, South Korea, 03722
Actively Recruiting
Research Team
I
Iksung Cho
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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