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

December 19, 2006
November 25, 2013
January 2007
April 2012   (final data collection date for primary outcome measure)
Functional capacity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Functional capacity at 1 year
Complete list of historical versions of study NCT00413998 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Health related quality of life at 1 year
  • Cardiac function at 1 year
  • Mitral regurgitation grade at 1 year
  • Neurohormonal levels at 1 year
Not Provided
Not Provided
 
Randomised Ischaemic Mitral Evaluation (RIME) Trial
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Mitral Regurgitation
  • Coronary Artery Disease
  • Procedure: CABG + Mitral valve annuloplasty
    Patients will receive a mitral annuloplasty ring in addition to coronary artery bypass grafting.
  • Procedure: CABG
    Patients will undergo coronary artery bypass grafting alone.
  • Experimental: CABG + Mitral valve repair
    Intervention: Procedure: CABG + Mitral valve annuloplasty
  • Active Comparator: CABG only
    Intervention: Procedure: CABG

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
August 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Poland,   United Kingdom
 
NCT00413998
2006HS020B, NIHR Portfolio ID 4129
Yes
Imperial College London
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
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
Imperial College London
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP