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Randomised Ischaemic Mitral Evaluation (RIME) Trial (RIME)

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ClinicalTrials.gov Identifier: NCT00413998
Recruitment Status : Completed
First Posted : December 20, 2006
Last Update Posted : June 4, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mitral Regurgitation Coronary Artery Disease Procedure: CABG + Mitral valve annuloplasty Procedure: CABG Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Evaluation of Mitral Annuloplasty During Coronary Artery Bypass Grafting for Moderate Functional Ischaemic Mitral Regurgitation.
Study Start Date : January 2007
Primary Completion Date : April 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :
  1. Functional capacity [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Left ventricular volumes [ Time Frame: 1 year ]
  2. Mitral regurgitation grade [ Time Frame: 1 year ]
  3. Neurohormonal levels [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413998

1st Dept of Cardiothoracic Surgery, Medical University of Silesia
Katowice, Poland
United Kingdom
Blackpool Victoria Hospital
Blackpool, Lancashire, United Kingdom, FY3 8NR
Bristol Heart Institute
Bristol, United Kingdom
Harefield Hospital
Harefield, United Kingdom, UB9 6UJ
Glenfield Hospital, Leicester
Leicester, United Kingdom, LE3 9QP
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Hammersmith Hospital
London, United Kingdom, W12 0HS
Heart Hospital, University College Hospital
London, United Kingdom, W1G 8PH
St. Mary's Hospital
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
Department of Health, United Kingdom
British Heart Foundation
British Medical Association
Royal Brompton & Harefield NHS Foundation Trust
Imperial College Healthcare NHS Trust
University Hospitals, Leicester
Medical University of Silesia
University Hospitals Bristol NHS Foundation Trust
Blackpool Victoria Hospital
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
More Information

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00413998     History of Changes
Other Study ID Numbers: 2006HS020B
NIHR Portfolio ID 4129 ( Other Grant/Funding Number: National Institute for Health Research )
First Posted: December 20, 2006    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: August 2013

Keywords provided by Imperial College London:
Functional ischaemic mitral regurgitation

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Mitral Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Heart Valve Diseases