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Coronary Heart Disease Complicated With Ischemic Mitral Regurgitation in China (China-IMR)

N

National Center for Cardiovascular Diseases

Status

Not yet enrolling

Conditions

Ischemic Mitral Regurgitation
Coronary Heart Disease (CHD)

Study type

Observational

Funder types

Other

Identifiers

NCT07230756
2024-GSP-TJ-7

Details and patient eligibility

About

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.

Enrollment

6,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

6,000 participants in 2 patient groups

GDMT Group
Non-GDMT Group

Trial contacts and locations

0

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Central trial contact

Erli Zhang, MD, PhD

Data sourced from clinicaltrials.gov

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