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Not yet recruiting NCT07230756

Coronary Heart Disease Complicated With Ischemic Mitral Regurgitation in China

Observational Ischemic Mitral Regurgitation Coronary Heart Disease (CHD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Ischemic Mitral Regurgitation, Coronary Heart Disease (CHD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Composite endpoint of heart failure hospitalization and all-cause death [Time frame: 3, 6, 12, 24 months]
Secondary outcome measures (3)
  • Change in mitral regurgitation severity [Time frame: 3 month, 6 month, 12 month, 24 month]
  • All-cause mortality [Time frame: 3 month, 6 month, 12 month, 24 month]
  • Hospitalization for heart failure [Time frame: 3, 6, 12, 24 months]

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:
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07230756 · 2024-GSP-TJ-7

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗