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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Functional capacity
Time Frame: 1 year
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Imperial College London

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2006

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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