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
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 (echocardiography, CT, MRI) or surgical findings.
- Patients aged 20 to 80 years with moderate or greater aortic valve stenosis or regurgitation (early calcification group).
- Patients aged 20 to 80 years with mild or less aortic valve stenosis or regurgitation (normal valve function group).
- Patients who understand the study purpose and voluntarily agree to participate.
You will not qualify if you...
- Patients with malignant cancers or other serious conditions like stroke that predict survival less than 6 months.
- Patients without clear confirmation of bicuspid aortic valve.
- Patients with stage 3 or higher chronic kidney disease.
- Patients with other inherited heart conditions.
- Patients with cognitive impairment or unstable heart function who cannot understand the study.
AI-Screening
AI-Powered Screening
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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
CONTACT
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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