Randomised Ischaemic Mitral Evaluation (RIME) Trial (RIME)

March 24, 2023 updated by: Imperial College London

Randomized Evaluation of Mitral Annuloplasty During Coronary Artery Bypass Grafting for Moderate Functional Ischaemic Mitral Regurgitation.

The study is a randomised controlled trial comparing two treatment strategies for patients with moderate functional ischaemic mitral regurgitation undergoing coronary artery bypass grafting (CABG). Patients will be randomised to receive either CABG alone or CABG plus mitral annuloplasty. The objective of the study is to determine if mitral annuloplasty in addition to CABG improves outcome in patients with moderate functional ischaemic mitral regurgitation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

70 patients with moderate functional ischaemic MR who are undergoing CABG will be recruited. Patients will be randomised to undergo either CABG alone or CABG combined with mitral annuloplasty. Patients will be investigated at baseline, 3 months and 1 year after surgery to determine functional capacity, quality of life, and cardiac function.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Early Phase 1

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

  • Poland
      • Katowice, Poland
        • 1st Dept of Cardiothoracic Surgery, Medical University of Silesia
  • United Kingdom
      • Bristol, United Kingdom
        • Bristol Heart Institute
      • Harefield, United Kingdom, UB9 6UJ
        • Harefield Hospital
      • Leicester, United Kingdom, LE3 9QP
        • Glenfield Hospital, Leicester
      • London, United Kingdom, W2 1NY
        • St. Mary's Hospital
      • London, United Kingdom, W12 0HS
        • Hammersmith Hospital
      • London, United Kingdom, SW3 6NP
        • Royal Brompton Hospital
      • London, United Kingdom, W1G 8PH
        • Heart Hospital, University College Hospital
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY3 8NR
        • Blackpool Victoria Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients undergoing CABG.
  2. Patients with moderate functional ischaemic mitral regurgitation without leaflet prolapse.

Exclusion Criteria:

  1. Patients with severe LV dysfunction (EF less than 30%).
  2. Patients with associated significant aortic valve disease.
  3. Patients with significant co-morbidities: renal impairment (creatinine > 160), liver impairment (INR > 2.0, bilirubin > 40), or underlying chronic obstructive lung disease (FEV1:FVC ratio < 0.6).
  4. Patients with NYHA class IV symptoms, unstable angina, acute pulmonary oedema or cardiogenic shock.
  5. Patients unsuitable for surgery e.g. patients with advanced malignancy, unable to give informed consent.
  6. Patients with structural abnormalities of the mitral valve e.g. papillary muscle rupture, chordal rupture, etc.
  7. Patients with associated conditions which would significantly increase the risk of surgery.
  8. Patients who have had previous cardiac surgery.
  9. Patients with a previous history of endocarditis

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CABG + Mitral valve repair
Procedure: CABG + Mitral valve annuloplasty
Patients will receive a mitral annuloplasty ring in addition to coronary artery bypass grafting.
Active Comparator: CABG only
Procedure: CABG
Patients will undergo coronary artery bypass grafting alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional capacity
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Mitral regurgitation grade
Time Frame: 1 year
1 year
Left ventricular volumes
Time Frame: 1 year
1 year
Neurohormonal levels
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Imperial College London

Collaborators

University Hospitals, Leicester
Medical University of Silesia
Royal Brompton & Harefield NHS Foundation Trust
British Heart Foundation
University Hospitals Bristol and Weston NHS Foundation Trust
Imperial College Healthcare NHS Trust
Blackpool Victoria Hospital
Department of Health, United Kingdom
British Medical Association

Investigators

  • Study Chair: John R Pepper, MChir, FRCS, Royal Brompton & Harefield NHS Foundation Trust
  • Principal Investigator: Marcus Flather, MBBS, FRCP, Royal Brompton Hospital NHS Trust, London
  • Principal Investigator: K. M. John Chan, FRCS CTh, Royal Brompton Hospital NHS Trust, London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2007

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

December 19, 2006

First Submitted That Met QC Criteria

December 19, 2006

First Posted (Estimate)

December 20, 2006

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006HS020B
  • NIHR Portfolio ID 4129 (Other Grant/Funding Number: National Institute for Health Research)

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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