Coronary Heart Disease Complicated With Ischemic Mitral Regurgitation in China
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChina National Center for Cardiovascular Diseases
About this trial
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.
This 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years, secondary mitral regurgitation discovered during outpatient visit or hospitalization;
Have definite coronary heart disease
Segmental wall motion abnormality or
Mitral regurgitation is consistent with Carpentier type IIIb (eccentric regurgitation)
Disqualifiers
Patients within the past year or currently participating in other clinical studies;
Primary mitral regurgitation (such as mitral valve prolapse, perforation, chordae tendineae rupture, etc.);
Dilated cardiomyopathy, hypertrophic cardiomyopathy and other diseases;
Moderate and above aortic stenosis/regurgitation, mitral stenosis, tricuspid stenosis, etc.;
Trial population
People with coronary heart disease combined with ischemic mitral regurgitation
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
6,000 Participants
are grouped into 2 trial groupsGroup A: GDMT Group
Group B: Non-GDMT Group
Trial outcomes
Primary outcomes
1
Composite endpoint of heart failure hospitalization and all-cause death
Time to first occurrence of either hospitalization for heart failure or death from any cause, whichever occurs first.
Time frame
3, 6, 12, 24 monthsSecondary outcomes
1
Change in mitral regurgitation severity
Change in mitral regurgitation (MR) grade from baseline to 24 months as assessed by echocardiography, measured using standard semiquantitative grading (none, mild, moderate, severe).
Time frame
3 month, 6 month, 12 month, 24 month2
All-cause mortality
Incidence of death due to any cause during the follow-up period
Time frame
3 month, 6 month, 12 month, 24 month3
Hospitalization for heart failure
Incidence of unplanned hospital admission primarily for management of heart failure symptoms.
Time frame
3, 6, 12, 24 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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