NCT05141292

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 2, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 4, 2022

Status Verified

January 1, 2022

Enrollment Period

7.8 years

First QC Date

November 19, 2021

Last Update Submit

January 21, 2022

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Number of death (all cause)

    Number of death within 2 years of discharge

    1 years of follow-up

Secondary Outcomes (1)

  • Number of rehospitalizations

    1 years of follow-up

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with heart failure accorrding to Inclusion and exclusion criteria.

You may qualify if:

  • 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

You may not qualify if:

  • Age ≤ 18 years
  • Failure to obtain medical records and ultrasound data
  • Refuse follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Related Publications (2)

  • Zhou N, Zhang K, Qiao B, Chen C, Guo X, Fu W, Zheng J, Du J, Dong R. Personalized risk prediction of mortality and rehospitalization for heart failure in patients undergoing mitral valve repair surgery. Front Cardiovasc Med. 2024 Nov 1;11:1470987. doi: 10.3389/fcvm.2024.1470987. eCollection 2024.

    PMID: 39553845DERIVED

  • Zhou N, Ji Z, Li F, Qiao B, Lin R, Jiang W, Zhu Y, Lin Y, Zhang K, Li S, You B, Gao P, Dong R, Wang Y, Du J. Machine Learning-Based Personalized Risk Prediction Model for Mortality of Patients Undergoing Mitral Valve Surgery: The PRIME Score. Front Cardiovasc Med. 2022 Apr 1;9:866257. doi: 10.3389/fcvm.2022.866257. eCollection 2022.

    PMID: 35433879DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Jie Du

    The Key Laboratory of Remodeling-Related Cardiovascular Disease, Ministry of Education, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart,Lung and Blood Vessel Diseases

    STUDY DIRECTOR

Central Study Contacts

Yuan Wang, Dr

CONTACT

13910161443wangyuan980510@163.com

Ning Zhou, Dr

CONTACT

18611179515drzhou9515@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2021

First Posted

December 2, 2021

Study Start

April 1, 2016

Primary Completion

December 31, 2023

Study Completion

December 31, 2025

Last Updated

February 4, 2022

Record last verified: 2022-01

Locations

CN(1)