Study on Surgical Treatment Strategies for Moderate Ischemic Mitral Regurgitation

May 13, 2024 updated by: China National Center for Cardiovascular Diseases
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

464

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
coronary artery bypass grafting
Procedure: mitral valve repair
coronary artery bypass grafting concomitant mitral valve repair
coronary artery bypass grafting concomitant mitral valve repair
Procedure: mitral valve repair
coronary artery bypass grafting concomitant mitral valve repair

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

April 1, 2024

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

May 7, 2024

First Submitted That Met QC Criteria

May 7, 2024

First Posted (Actual)

May 10, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 13, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • m_IMR_2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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