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Coronary Heart Disease Complicated With Ischemic Mitral Regurgitation in China

A Prospective Cohort Study of Coronary Heart Disease Complicated With Ischemic Mitral Regurgitation in China

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07230756
Acronym
China-IMR
Enrollment
6000
Registered
2025-11-17
Start date
2025-11-10
Completion date
2029-12-31
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease (CHD), Ischemic Mitral Regurgitation

Brief summary

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.

Interventions

None listed

Sponsors

China National Center for Cardiovascular Diseases
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥18 years, secondary mitral regurgitation discovered during outpatient visit or hospitalization; * Have definite coronary heart disease * Cardiac ultrasound: consistent with mitral regurgitation caused by myocardial ischemia or myocardial infarction: 1. Segmental wall motion abnormality or 2. Mitral regurgitation is consistent with Carpentier type IIIb (eccentric regurgitation) * Cardiac ultrasound prompts: moderate or above ischemic mitral regurgitation

Exclusion criteria

* 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.; * Patients who have undergone cardiac valve intervention/surgery.

Design outcomes

Primary

MeasureTime frameDescription
Composite endpoint of heart failure hospitalization and all-cause death3, 6, 12, 24 monthsTime to first occurrence of either hospitalization for heart failure or death from any cause, whichever occurs first.

Secondary

MeasureTime frameDescription
Change in mitral regurgitation severity3 month, 6 month, 12 month, 24 monthChange in mitral regurgitation (MR) grade from baseline to 24 months as assessed by echocardiography, measured using standard semiquantitative grading (none, mild, moderate, severe).
All-cause mortality3 month, 6 month, 12 month, 24 monthIncidence of death due to any cause during the follow-up period
Hospitalization for heart failure3, 6, 12, 24 monthsIncidence of unplanned hospital admission primarily for management of heart failure symptoms.

Contacts

Primary ContactErli Zhang, MD, PhD
zhangerli@fuaihospital.org+86-18500853301

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026