Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT07230756
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Coronary Heart Disease Complicated With Ischemic Mitral Regurgitation in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': "Investigators will collect blood samples from up to 2,500 patients, separate patients' plasma, serum, and peripheral blood RNA, and store them long-term in the biobank of the National Center for Cardiovascular Diseases. These samples will be used for future extended studies, such as nested cohort studies , with the aim of discovering new biomarkers and other purposes."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-01-02', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite endpoint of heart failure hospitalization and all-cause death', 'timeFrame': '3, 6, 12, 24 months', 'description': 'Time to first occurrence of either hospitalization for heart failure or death from any cause, whichever occurs first.'}], 'secondaryOutcomes': [{'measure': 'Change in mitral regurgitation severity', 'timeFrame': '3 month, 6 month, 12 month, 24 month', 'description': 'Change in mitral regurgitation (MR) grade from baseline to 24 months as assessed by echocardiography, measured using standard semiquantitative grading (none, mild, moderate, severe).'}, {'measure': 'All-cause mortality', 'timeFrame': '3 month, 6 month, 12 month, 24 month', 'description': 'Incidence of death due to any cause during the follow-up period'}, {'measure': 'Hospitalization for heart failure', 'timeFrame': '3, 6, 12, 24 months', 'description': 'Incidence of unplanned hospital admission primarily for management of heart failure symptoms.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemic Mitral Regurgitation', 'Coronary Heart Disease (CHD)']}, 'descriptionModule': {'briefSummary': "This project will rely on the established multi-center cooperation platform for total valve disease and based on the Carpentier classification, which is newly proposed and widely recognized by the academic community, and will specifically target the population with coronary heart disease combined with Ischemic Mitral Regurgitation（IMR） to conduct a nationwide, multi-center, single valve disease, prospective cohort. Research. From November 2025 to December 2025, 6,000 patients with coronary heart disease combined with moderate or above IMR were consecutively selected from outpatients or inpatients in 21 regional medical centers across the country, and clinical characteristics, imaging data, and serology were collected. Information, drug/surgical intervention status and clinical outcome indicators were included in the clinical follow-up at baseline, 3 months, 6 months, 12 months and 24 months respectively. The main research objectives are to describe the disease characteristics, treatment status and clinical outcomes of coronary heart disease patients with IMR; to evaluate the current application status of GDMT strategies in IMR diagnosis and treatment practice and its impact on mid- and long-term prognosis. The secondary research objectives are to identify factors affecting prognosis, construct a risk stratification model for mid- and long-term prognosis, and discover new molecular markers.\n\nThis project will for the first time construct the world's largest clearly defined cohort of coronary heart disease combined with IMR. Its research results can provide high-quality data and decision-making basis for precise diagnosis and treatment of IMR populations. Therefore, this project has important scientific research value and clinical guidance significance."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People with coronary heart disease combined with ischemic mitral regurgitation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years, secondary mitral regurgitation discovered during outpatient visit or hospitalization;\n* Have definite coronary heart disease\n* Cardiac ultrasound: consistent with mitral regurgitation caused by myocardial ischemia or myocardial infarction:\n\n 1. Segmental wall motion abnormality or\n 2. Mitral regurgitation is consistent with Carpentier type IIIb (eccentric regurgitation)\n* Cardiac ultrasound prompts: moderate or above ischemic mitral regurgitation\n\nExclusion Criteria:\n\n* Patients within the past year or currently participating in other clinical studies;\n* Primary mitral regurgitation (such as mitral valve prolapse, perforation, chordae tendineae rupture, etc.);\n* Dilated cardiomyopathy, hypertrophic cardiomyopathy and other diseases;\n* Moderate and above aortic stenosis/regurgitation, mitral stenosis, tricuspid stenosis, etc.;\n* Patients who have undergone cardiac valve intervention/surgery.'}, 'identificationModule': {'nctId': 'NCT07230756', 'acronym': 'China-IMR', 'briefTitle': 'Coronary Heart Disease Complicated With Ischemic Mitral Regurgitation in China', 'organization': {'class': 'OTHER_GOV', 'fullName': 'China National Center for Cardiovascular Diseases'}, 'officialTitle': 'A Prospective Cohort Study of Coronary Heart Disease Complicated With Ischemic Mitral Regurgitation in China', 'orgStudyIdInfo': {'id': '2024-GSP-TJ-7'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GDMT Group'}, {'label': 'Non-GDMT Group'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Erli Zhang, MD, PhD', 'role': 'CONTACT', 'email': 'zhangerli@fuaihospital.org', 'phone': '+86-18500853301'}], 'overallOfficials': [{'name': 'Erli Zhang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China National Center for Cardiovascular Diseases'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}