Epicardial Mitral Touch System for Mitral Insufficiency
NCT04396379
Functional Mitral Regurgitation, Ischemic Mitral Regurgitation
Plano, Texas, United States
View Trial DetailsNCT Number: NCT07230756
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
Time frame: 3 month, 6 month, 12 month, 24 month
Incidence of death due to any cause during the follow-up period
Time frame: 3, 6, 12, 24 months
Incidence of unplanned hospital admission primarily for management of heart failure symptoms.
Contact information is provided by the study sponsor or research team.
China National Center for Cardiovascular Diseases
Other Gov
A Prospective Cohort Study of Coronary Heart Disease Complicated With Ischemic Mitral Regurgitation in China
Acronym: China-IMR
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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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