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

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • First Affiliated Hospital, Sun Yat-Sen University
        • Contact:
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Third Affiliated Hospital, Sun Yat-Sun University
        • Contact:
      • Jieyang, Guangdong, China, 522000
        • Recruiting
        • Jieyang People's Hospital
        • Contact:
      • Shantou, Guangdong, China, 515041
        • Recruiting
        • Second Affiliated Hospital of Shantou University Medical College
        • Contact:
      • Shenzhen, Guangdong, China, 518000
        • Recruiting
        • Eighth Affiliated Hospital, Sun Yat-sen University
        • Contact:
      • Zhanjiang, Guangdong, China, 524001
        • Recruiting
        • Affiliated Hospital of Guangdong Medical University
        • Contact:
      • Zhongshan, Guangdong, China, 528400
        • Recruiting
        • Zhongshan People's Hospital
        • Contact:

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

Sun Yat-sen University

Collaborators

First Affiliated Hospital, Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University
Zhongshan People's Hospital, Guangdong, China
Jieyang People's Hospital
Eighth Affiliated Hospital, Sun Yat-sen University
Second Affiliated Hospital of Shantou University Medical College
Affiliated Hospital of Guangdong Medical University

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

Keywords

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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