Study on Surgical Treatment Strategies for Moderate Ischemic Mitral Regurgitation

NCT06408779 | Completed

• 1 other identifier: m_IMR_2024
• Study Type: observational
• Target: 464
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Valve Insufficiency; Mitral Valve Annuloplasty; Coronary Artery Bypass

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

coronary artery bypass grafting

Procedure: mitral valve repair

coronary artery bypass grafting concomitant mitral valve repair

Procedure: mitral valve repair

Interventions

mitral valve repair PROCEDURE

coronary artery bypass grafting concomitant mitral valve repair

coronary artery bypass grafting; coronary artery bypass grafting concomitant mitral valve repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult coronary artery disease patients complicated with moderate ischemic mitral regurgitation undergoing coronary artery bypass grafting with or without mitral valve repair from August 2009 to August 2023 were enrolled

You may qualify if:

• Adult coronary artery disease patients complicated with moderate ischemic mitral regurgitation.
• undergoing coronary artery bypass grafting with or without mitral valve repair.

You may not qualify if:

• patients under the age of 18 years,
• patients complicated with more than moderate ischemic mitral regurgitation or undergoing mitral valve replacement,
• patients complicated with primary mitral valve disease other than ischemic mitral regurgitation, such as rheumatic mitral regurgitation or mitral valve leaflet prolapse,
• patients undergoing concomitant aortic valve procedure.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Interventions

Mitral Valve Annuloplasty

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Valve Annuloplasty; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: August 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

CN (1)