ARISTOTLE: Aortic Valve Diseases RISk facTOr assessmenT and Prognosis modeL Construction

Sponsor

Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06069232

Collaborator

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

2,000

Enrollment

Locations

Anticipated Duration (Months)

285.7

Patients Per Site

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Disease

Study Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2028

Anticipated Study Completion Date :

Mar 1, 2028

Outcome Measures

Primary Outcome Measures

all-cause mortality [from baseline to death or end of follow-up]
death caused by any cause

Secondary Outcome Measures

Cardiovascular death [from baseline to death or end of follow-up]
Death caused by cardiac causes
Aortic valve replacement [from baseline to aortic valve replacement]
Transcatheter aortic valve replacement or surgical aortic valve replacement

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

age ≥ 18
diagnosed as aortic valve disease

Exclusion Criteria:

aortic valve replacement at baseline

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Guangdong	China	510000
2	Third Affiliated Hospital, Sun Yat-Sun University	Guangzhou	Guangdong	China	510000
3	Jieyang People's Hospital	Jieyang	Guangdong	China	522000
4	Second Affiliated Hospital of Shantou University Medical College	Shantou	Guangdong	China	515041
5	Eighth Affiliated Hospital, Sun Yat-Sen University	Shenzhen	Guangdong	China	518000
6	Affiliated Hospital of Guangdong Medical University	Zhanjiang	Guangdong	China	524001
7	Zhongshan People's Hospital	Zhongshan	Guangdong	China	528400