Randomised Ischaemic Mitral Evaluation (RIME) Trial

This study has been completed.
Sponsor:
Collaborators:
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
United Bristol Healthcare NHS Trust
Blackpool Teaching Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT00413998
First received: December 19, 2006
Last updated: November 25, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Mitral Regurgitation
Coronary Artery Disease
Procedure: CABG + Mitral valve annuloplasty
Procedure: CABG
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Evaluation of Mitral Annuloplasty During Coronary Artery Bypass Grafting for Moderate Functional Ischaemic Mitral Regurgitation.

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Functional capacity [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Left ventricular volumes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Mitral regurgitation grade [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Neurohormonal levels [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 73
Study Start Date: January 2007
Study Completion Date: August 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413998

Locations
Poland
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
Hammersmith Hospital
London, United Kingdom, W12 0HS
Heart Hospital, University College Hospital
London, United Kingdom, W1G 8PH
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
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
United Bristol Healthcare NHS Trust
Blackpool Teaching Hospitals NHS Foundation Trust
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
  More Information

Publications:
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00413998     History of Changes
Other Study ID Numbers: 2006HS020B, NIHR Portfolio ID 4129
Study First Received: December 19, 2006
Last Updated: November 25, 2013
Health Authority: United Kingdom: Research Ethics Committee

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
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Heart Valve Diseases

ClinicalTrials.gov processed this record on July 29, 2014