Study on Surgical Treatment Strategies for Moderate Ischemic Mitral Regurgitation

Completed

• Conditions: Mitral Valve Insufficiency; Mitral Valve Annuloplasty; Coronary Artery Bypass
• Interventions: Procedure: mitral valve repair

• Registration Number: NCT06408779
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-01
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-07
• Study First Submitted QC: 2024-05-07
• Study First Posted: 2024-05-10
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 464

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
coronary artery bypass grafting	mitral valve repair	-
coronary artery bypass grafting concomitant mitral valve repair	mitral valve repair	-

Primary Outcome Measures

Name	Time	Method
major adverse cardiovascular and cerebrovascular events	2years	the composite of all-cause death, rehospitalization for heart failure, non-fatal myocardial infarction, non-fatal stroke or repeat mitral valve surgery.

Trial Locations

Locations (1)

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, China