Cardiovascular DiseasesNCT05141292
A Registry Study of Biomarkers in Mitral Valve Disease (BIOMS-MVD)
An observational study of Cardiovascular Diseases, run by Beijing Institute of Heart, Lung and Blood Vessel Diseases at 1 site in China.
Trial summary
The registry study aims to discover the prognostic value of bio-markers in mitral valve disease Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2016to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: Patients with heart failure accorrding to Inclusion and exclusion criteria.
Who may be able to join
- 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
Who cannot join
- Age ≤ 18 years
- Failure to obtain medical records and ultrasound data
- Refuse follow-up
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Yuan WANG, PhD, 86-010-64456169, wangyuan980510@163.com
About this study
Official title: A Registry Study of Biomarkers in Mitral Valve Disease
The registry study aims to discover the prognostic value of bio-markers in mitral valve disease
Read the detailed 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.
- Conditions
- Cardiovascular Diseases
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of death (all cause)
Number of death within 2 years of discharge
Measured: 1 years of follow-up
Secondary outcomes (1)
Number of rehospitalizations
Number of heart failure related hospitalization within 1 years of discharge
Measured: 1 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start1 Apr 2016
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Responsible party
- Sponsor
- Investigators
- Jie Du, Study director, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141292
- Sponsor's protocol ID
- BIOMS-MVD
- Status last verified
- Jan 2022
- First submitted
- 19 Nov 2021
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39553845Zhou 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.
PubMed 35433879
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry Study of Biomarkers in Mitral Valve Disease
- ClinicalTrials.gov ID
- NCT05141292
- Acronym / sponsor ID
- BIOMS-MVD
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel DiseasesUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The registry study aims to discover the prognostic value of bio-markers in mitral valve disease
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with heart failure accorrding to Inclusion and exclusion criteria.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Age ≤ 18 years
- Failure to obtain medical records and ultrasound data
- Refuse follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of death (all cause)
Time frame: 1 years of follow-up
Number of death within 2 years of discharge
1 secondary outcome
Number of rehospitalizations
Time frame: 1 years of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Derived from this study: PubMed 39553845Zhou 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.
- Derived from this study: PubMed 35433879Zhou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Du study director
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Beijing Institute of Heart, Lung and Blood Vessel Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuan Wang, Dr (13910161443, wangyuan980510@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of death (all cause) (time frame: 1 years of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05141292, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.