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NCT06069232 Clinical Trial

Aortic Valve Diseases RISk facTOr assessmenT and Prognosis modeL Construction

Aortic Valve Disease Clinical Trial

— ARISTOTLE  

Official title:
Aortic Valve Diseases RISk facTOr assessmenT and Prognosis modeL Construction (ARISTOTLE)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06069232
Other study ID # ARISTOTLE Study
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date March 1, 2028

Study information
Verified date October 2023
Source Sun Yat-sen University
Contact xiaodong zhuang, PhD
Phone +86 13760755035
Email zhuangxd3@mail.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is a multicenter cohort study including patients diagnosed with aortic valve disease during hospitalization, including aortic insufficiency and aortic valve stenosis. The primary outcome of the study was all-cause death, and the secondary outcome was cardiovascular events. Through follow-up observation, the prognostic risk factors of patients with aortic disease were evaluated, and a prognostic model was constructed to guide clinical decision-making.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date March 1, 2028
Est. primary completion date March 1, 2028
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - age = 18 - diagnosed as aortic valve disease Exclusion Criteria: - aortic valve replacement at baseline

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China First Affiliated Hospital, Sun Yat-Sen University Guangzhou Guangdong
China Third Affiliated Hospital, Sun Yat-Sun University Guangzhou Guangdong
China Jieyang People's Hospital Jieyang Guangdong
China Second Affiliated Hospital of Shantou University Medical College Shantou Guangdong
China Eighth Affiliated Hospital, Sun Yat-Sen University Shenzhen Guangdong
China Affiliated Hospital of Guangdong Medical University Zhanjiang Guangdong
China Zhongshan People's Hospital Zhongshan Guangdong

Sponsors (8)
Lead Sponsor Collaborator
Sun Yat-sen University Affiliated Hospital of Guangdong Medical University, Eighth Affiliated Hospital, Sun Yat-sen University, First Affiliated Hospital, Sun Yat-Sen University, Jieyang People's Hospital, Second Affiliated Hospital of Shantou University Medical College, Third Affiliated Hospital, Sun Yat-Sen University, Zhongshan People's Hospital, Guangdong, China

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary all-cause mortality death caused by any cause from baseline to death or end of follow-up
Secondary Cardiovascular death Death caused by cardiac causes from baseline to death or end of follow-up
Secondary Aortic valve replacement Transcatheter aortic valve replacement or surgical aortic valve replacement from baseline to aortic valve replacement
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