A Prospective Cohort Study of Coronary Heart Disease Complicated With Ischemic Mitral Regurgitation in China
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6,000
- 主要终点
- Composite endpoint of heart failure hospitalization and all-cause death
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Composite endpoint of heart failure hospitalization and all-cause death
时间窗: 3, 6, 12, 24 months
Time to first occurrence of either hospitalization for heart failure or death from any cause, whichever occurs first.
次要结局
- 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)