- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06069232
Aortic Valve Diseases RISk facTOr assessmenT and Prognosis modeL Construction (ARISTOTLE)
October 10, 2023 updated by: Xiao-dong Zhuang, Sun Yat-sen University
Aortic Valve Diseases RISk facTOr assessmenT and Prognosis modeL Construction (ARISTOTLE)
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiaodong Zhuang, PhD
- Phone Number: +86 13760755035
- Email: zhuangxd3@mail.sysu.edu.cn
Study Locations
-
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Guangdong
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Guangzhou, Guangdong, China, 510000
- Recruiting
- First Affiliated Hospital, Sun Yat-Sen University
-
Contact:
- Xiaodong Zhuang, PhD
- Phone Number: +86 13760755035
- Email: zhuangxd3@mail.sysu.edu.cn
-
Guangzhou, Guangdong, China, 510000
- Recruiting
- Third Affiliated Hospital, Sun Yat-Sun University
-
Contact:
- Zhuoshan Huang, PhD
- Phone Number: +86 13728059476
- Email: huangzhsh@mail.sysu.edu.cn
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Jieyang, Guangdong, China, 522000
- Recruiting
- Jieyang People's Hospital
-
Contact:
- Mingwei Xu, PhD
- Phone Number: 13828186368
- Email: versy@163.com
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Shantou, Guangdong, China, 515041
- Recruiting
- Second Affiliated Hospital of Shantou University Medical College
-
Contact:
- Jilin Li, PhD
- Phone Number: +86 13592852807
- Email: lijilin@126.com
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Shenzhen, Guangdong, China, 518000
- Recruiting
- Eighth Affiliated Hospital, Sun Yat-Sen University
-
Contact:
- jianwen liang, PhD
- Phone Number: +86 13688847419
- Email: liangjw39@mail.sysu.edu.cn
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Zhanjiang, Guangdong, China, 524001
- Recruiting
- Affiliated Hospital of Guangdong Medical University
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Contact:
- Jianying Chen, PhD
- Phone Number: +86 13828223032
- Email: jychen271@126.com
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Zhongshan, Guangdong, China, 528400
- Recruiting
- Zhongshan People's Hospital
-
Contact:
- Li Feng, PhD
- Phone Number: +86 13902593410
- Email: lifengdoc@126.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
The participant included in this study were patients with aortic valve disease diagnosed during hospitalization, and these patients were followed up for a long time after discharge.
Description
Inclusion Criteria:
- age ≥ 18
- diagnosed as aortic valve disease
Exclusion Criteria:
- aortic valve replacement at baseline
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
all-cause mortality
Time Frame: from baseline to death or end of follow-up
|
death caused by any cause
|
from baseline to death or end of follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiovascular death
Time Frame: from baseline to death or end of follow-up
|
Death caused by cardiac causes
|
from baseline to death or end of follow-up
|
Aortic valve replacement
Time Frame: from baseline to aortic valve replacement
|
Transcatheter aortic valve replacement or surgical aortic valve replacement
|
from baseline to aortic valve replacement
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Xiaodong Zhuang, PhD, First Affiliated Hospital, Sun Yat-Sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2021
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2028
Study Registration Dates
First Submitted
October 1, 2023
First Submitted That Met QC Criteria
October 1, 2023
First Posted (Actual)
October 5, 2023
Study Record Updates
Last Update Posted (Actual)
October 12, 2023
Last Update Submitted That Met QC Criteria
October 10, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARISTOTLE Study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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