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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ischemic Mitral Regurgitation; Coronary Heart Disease (CHD)

• Study Type: Observational
• Enrollment (Estimated): 6000

Contacts and Locations

• Study Contact: Name: Erli Zhang, MD, PhD; Phone Number: +86-18500853301; Email: zhangerli@fuaihospital.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

People with coronary heart disease combined with ischemic mitral regurgitation

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
GDMT Group
Non-GDMT Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	3 month, 6 month, 12 month, 24 month
All-cause mortality	Incidence of death due to any cause during the follow-up period	3 month, 6 month, 12 month, 24 month
Hospitalization for heart failure	Incidence of unplanned hospital admission primarily for management of heart failure symptoms.	3, 6, 12, 24 months

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Erli Zhang, MD, PhD, China National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Estimated): November 10, 2025
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: January 2, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2024-GSP-TJ-7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No