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NCT06408779 Clinical Trial

Study on Surgical Treatment Strategies for Moderate Ischemic Mitral Regurgitation

Mitral Valve Insufficiency Clinical Trial

Official title:
Study on Surgical Treatment Strategies for Moderate Ischemic Mitral Regurgitation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06408779
Other study ID # m_IMR_2024
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2023
Est. completion date April 1, 2024

Study information
Verified date May 2024
Source China National Center for Cardiovascular Diseases
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aimed to compare the efficacy of isolated coronary artery bypass grafting and coronary artery bypass grafting + mitral valve repair in moderate ischemic mitral regurgitation patients through a cohort and explore the potential risk factors of the clinical outcomes.

Recruitment information / eligibility
Status Completed
Enrollment 464
Est. completion date April 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Adult coronary artery disease patients complicated with moderate ischemic mitral regurgitation. 2. undergoing coronary artery bypass grafting with or without mitral valve repair. Exclusion Criteria: 1. patients under the age of 18 years, 2. patients complicated with more than moderate ischemic mitral regurgitation or undergoing mitral valve replacement, 3. patients complicated with primary mitral valve disease other than ischemic mitral regurgitation, such as rheumatic mitral regurgitation or mitral valve leaflet prolapse, 4. patients undergoing concomitant aortic valve procedure.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• mitral valve repair
coronary artery bypass grafting concomitant mitral valve repair

Locations
Country Name City State
China Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing

Sponsors (1)
Lead Sponsor Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary major adverse cardiovascular and cerebrovascular events the composite of all-cause death, rehospitalization for heart failure, non-fatal myocardial infarction, non-fatal stroke or repeat mitral valve surgery. 2years
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