Coronary Heart Disease Complicated With Ischemic Mitral Regurgitation in China

NCT ID: NCT07230756

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 6000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-10
• Study Completion Date: 2029-12-31

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.

Conditions

Ischemic Mitral Regurgitation; Coronary Heart Disease (CHD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

GDMT Group

No interventions assigned to this group

Non-GDMT Group

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erli Zhang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

China National Center for Cardiovascular Diseases

Central Contacts

Erli Zhang, MD, PhD

Role: CONTACT

zhangerli@fuaihospital.org

+86-18500853301

Other Identifiers

2024-GSP-TJ-7

Identifier Type: -

Identifier Source: org_study_id