Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-26 @ 12:13 AM
Study NCT ID:
NCT05141292
Status:
RECRUITING
Last Update Posted:
2022-02-04
First Post:
2021-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Registry Study of Biomarkers in Mitral Valve Disease (BIOMS-MVD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-21', 'studyFirstSubmitDate': '2021-11-19', 'studyFirstSubmitQcDate': '2021-11-19', 'lastUpdatePostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of death (all cause)', 'timeFrame': '1 years of follow-up', 'description': 'Number of death within 2 years of discharge'}], 'secondaryOutcomes': [{'measure': 'Number of rehospitalizations', 'timeFrame': '1 years of follow-up', 'description': 'Number of heart failure related hospitalization within 1 years of discharge'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '39553845', 'type': 'DERIVED', 'citation': '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': '35433879', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The registry study aims to discover the prognostic value of bio-markers in mitral valve disease', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with heart failure accorrding to Inclusion and exclusion criteria.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients clinically diagnosed with mitral valve disease in Beijing Anzhen Hospital from April 2016 to December 2019\n* The operator performs more than 25 mitral valve operations per year / the operator unit has surgeons who complete 50 operations per year\n\nExclusion Criteria:\n\n* Age ≤ 18 years\n* Failure to obtain medical records and ultrasound data\n* Refuse follow-up'}, 'identificationModule': {'nctId': 'NCT05141292', 'briefTitle': 'A Registry Study of Biomarkers in Mitral Valve Disease (BIOMS-MVD)', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Institute of Heart, Lung and Blood Vessel Diseases'}, 'officialTitle': 'A Registry Study of Biomarkers in Mitral Valve Disease', 'orgStudyIdInfo': {'id': 'BIOMS-MVD'}}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuan WANG, PhD', 'role': 'CONTACT', 'email': 'wangyuan980510@163.com', 'phone': '86-010-64456169'}], 'facility': 'Beijing Anzhen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yuan Wang, Dr', 'role': 'CONTACT', 'email': 'wangyuan980510@163.com', 'phone': '13910161443'}, {'name': 'Ning Zhou, Dr', 'role': 'CONTACT', 'email': 'drzhou9515@163.com', 'phone': '18611179515'}], 'overallOfficials': [{'name': 'Jie Du', 'role': 'STUDY_DIRECTOR', 'affiliation': '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'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Institute of Heart, Lung and Blood Vessel Diseases', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}