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NCT Number: NCT07230756

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Segmental wall motion abnormality or
  • 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.

Treatment and study plan

Primary outcomes

  1. Composite endpoint of heart failure hospitalization and all-cause death

    Time frame: 3, 6, 12, 24 months

    Time to first occurrence of either hospitalization for heart failure or death from any cause, whichever occurs first.

Secondary outcomes

  1. Change in mitral regurgitation severity

    Time frame: 3 month, 6 month, 12 month, 24 month

    Change in mitral regurgitation (MR) grade from baseline to 24 months as assessed by echocardiography, measured using standard semiquantitative grading (none, mild, moderate, severe).

  2. All-cause mortality

    Time frame: 3 month, 6 month, 12 month, 24 month

    Incidence of death due to any cause during the follow-up period

  3. Hospitalization for heart failure

    Time frame: 3, 6, 12, 24 months

    Incidence of unplanned hospital admission primarily for management of heart failure symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Erli Zhang, MD, PhD

CONTACT

[email protected]

+86-18500853301

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

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

Acronym: China-IMR

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Nov 17, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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