Coronary Heart Disease Complicated With Ischemic Mitral Regurgitation in China

NCT07230756 | Not Yet Recruiting DMC

• 1 other identifier: 2024-GSP-TJ-7
• Study Type: observational
• Target: 6,000
• Locations: 0 countries
• Sites: N/A

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)

Outcome Measures

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.

  3, 6, 12, 24 months

Secondary Outcomes (3)

• Change in mitral regurgitation severity

  3 month, 6 month, 12 month, 24 month

• All-cause mortality

  3 month, 6 month, 12 month, 24 month

• Hospitalization for heart failure

  3, 6, 12, 24 months

Study Arms (2)

GDMT Group

Non-GDMT Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with coronary heart disease combined with ischemic mitral regurgitation

You may qualify if:

• 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:
• Segmental wall motion abnormality or
• Mitral regurgitation is consistent with Carpentier type IIIb (eccentric regurgitation)
• Cardiac ultrasound prompts: moderate or above ischemic mitral regurgitation

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Erli Zhang, MD, PhD

  China National Center for Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erli Zhang, MD, PhD

CONTACT

+86-18500853301; zhangerli@fuaihospital.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: November 17, 2025
• Study Start: November 10, 2025
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: November 17, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share