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NCT05141292 Clinical Trial

A Registry Study of Biomarkers in Mitral Valve Disease (BIOMS-MVD)

Cardiovascular Diseases Clinical Trial

Official title:
A Registry Study of Biomarkers in Mitral Valve Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05141292
Other study ID # BIOMS-MVD
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2016
Est. completion date December 31, 2025

Study information
Verified date January 2022
Source Beijing Institute of Heart, Lung and Blood Vessel Diseases
Contact Yuan Wang, Dr
Phone 13910161443
Email wangyuan980510@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The registry study aims to discover the prognostic value of bio-markers in mitral valve disease

Description:

The purpose of this study is to investigate the prognostic value of biomarkers in mitral valve disease.Patients with confirmed diagnosis of mitral valve disease are enrolled.The primary outcome is all-cause mortality based on the death certificates. The secondary outcome is readmission for heart failure and all-cause mortality/readmission for heart failure according to the patients' medical records.

Recruitment information / eligibility
Status Recruiting
Enrollment 5000
Est. completion date December 31, 2025
Est. primary completion date December 31, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Patients clinically diagnosed with mitral valve disease in Beijing Anzhen Hospital from April 2016 to December 2019 - The operator performs more than 25 mitral valve operations per year / the operator unit has surgeons who complete 50 operations per year Exclusion Criteria: - Age = 18 years - Failure to obtain medical records and ultrasound data - Refuse follow-up

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Beijing Anzhen Hospital Beijing Beijing

Sponsors (2)
Lead Sponsor Collaborator
Beijing Institute of Heart, Lung and Blood Vessel Diseases Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of death (all cause) Number of death within 2 years of discharge 1 years of follow-up
Secondary Number of rehospitalizations Number of heart failure related hospitalization within 1 years of discharge 1 years of follow-up
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