Status:
RECRUITING
Genetic Test Based Risk Prediction of Early Calcific Aortic Valve Disease in Patients With Bicuspid Aortic Valve
Lead Sponsor:
Yonsei University
Conditions:
Bicuspid Aortic Valve
Eligibility:
All Genders
19-80 years
Brief 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 wi...
Eligibility Criteria
Inclusion
- Patients with confirmed bicuspid aortic valves based on cardiac imaging (echocardiography, CT, MRI) or surgical findings.
- Early aortic valve calcification group: Patients aged 20-80 with moderate or greater aortic valve stenosis/regurgitation.
- Normal functioning aortic valve group: Patients aged 20-80 with mild or less aortic valve stenosis/regurgitation.
- Patients who understand the purpose of the study and voluntarily consent to participate.
Exclusion
- Patients with malignant neoplastic diseases or other conditions, such as cerebrovascular accidents, which predict survival of 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 patients who have difficulty understanding the study content.
Key Trial Info
Start Date :
October 19 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06153407
Start Date
October 19 2023
End Date
October 1 2028
Last Update
December 1 2023
Active Locations (1)
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1
Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine
Seoul, South Korea, 03722