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Randomised Ischaemic Mitral Evaluation (RIME) Trial (RIME)

Primary Purpose

Mitral Regurgitation, Coronary Artery Disease

Status
Completed
Phase
Early Phase 1
Locations
International
Study Type
Interventional
Intervention
CABG + Mitral valve annuloplasty
CABG
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mitral Regurgitation focused on measuring Functional ischaemic mitral regurgitation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 1st Dept of Cardiothoracic Surgery, Medical University of Silesia
  • Blackpool Victoria Hospital
  • Bristol Heart Institute
  • Harefield Hospital
  • Glenfield Hospital, Leicester
  • Royal Brompton Hospital
  • Hammersmith Hospital
  • Heart Hospital, University College Hospital
  • St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CABG + Mitral valve repair

CABG only

Arm Description

Outcomes

Primary Outcome Measures

Functional capacity

Secondary Outcome Measures

Left ventricular volumes
Mitral regurgitation grade
Neurohormonal levels

Full Information

First Posted
December 19, 2006
Last Updated
March 24, 2023
Sponsor
Imperial College London
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, University Hospitals Bristol and Weston NHS Foundation Trust, Blackpool Victoria Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00413998
Brief Title
Randomised Ischaemic Mitral Evaluation (RIME) Trial
Acronym
RIME
Official Title
Randomized Evaluation of Mitral Annuloplasty During Coronary Artery Bypass Grafting for Moderate Functional Ischaemic Mitral Regurgitation.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
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, University Hospitals Bristol and Weston NHS Foundation Trust, Blackpool Victoria Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Regurgitation, Coronary Artery Disease
Keywords
Functional ischaemic mitral regurgitation

7. Study Design

Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CABG + Mitral valve repair
Arm Type
Experimental
Arm Title
CABG only
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
CABG + Mitral valve annuloplasty
Intervention Description
Patients will receive a mitral annuloplasty ring in addition to coronary artery bypass grafting.
Intervention Type
Procedure
Intervention Name(s)
CABG
Intervention Description
Patients will undergo coronary artery bypass grafting alone.
Primary Outcome Measure Information:
Title
Functional capacity
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Left ventricular volumes
Time Frame
1 year
Title
Mitral regurgitation grade
Time Frame
1 year
Title
Neurohormonal levels
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing CABG. Patients with moderate functional ischaemic mitral regurgitation without leaflet prolapse. Exclusion Criteria: Patients with severe LV dysfunction (EF less than 30%). Patients with associated significant aortic valve disease. 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). Patients with NYHA class IV symptoms, unstable angina, acute pulmonary oedema or cardiogenic shock. Patients unsuitable for surgery e.g. patients with advanced malignancy, unable to give informed consent. Patients with structural abnormalities of the mitral valve e.g. papillary muscle rupture, chordal rupture, etc. Patients with associated conditions which would significantly increase the risk of surgery. Patients who have had previous cardiac surgery. Patients with a previous history of endocarditis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R Pepper, MChir, FRCS
Organizational Affiliation
Royal Brompton & Harefield NHS Foundation Trust
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marcus Flather, MBBS, FRCP
Organizational Affiliation
Royal Brompton Hospital NHS Trust, London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
K. M. John Chan, FRCS CTh
Organizational Affiliation
Royal Brompton Hospital NHS Trust, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
1st Dept of Cardiothoracic Surgery, Medical University of Silesia
City
Katowice
Country
Poland
Facility Name
Blackpool Victoria Hospital
City
Blackpool
State/Province
Lancashire
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Facility Name
Bristol Heart Institute
City
Bristol
Country
United Kingdom
Facility Name
Harefield Hospital
City
Harefield
ZIP/Postal Code
UB9 6UJ
Country
United Kingdom
Facility Name
Glenfield Hospital, Leicester
City
Leicester
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Heart Hospital, University College Hospital
City
London
ZIP/Postal Code
W1G 8PH
Country
United Kingdom
Facility Name
St. Mary's Hospital
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19410679
Citation
Chan KM, Amirak E, Zakkar M, Flather M, Pepper JR, Punjabi PP. Ischemic mitral regurgitation: in search of the best treatment for a common condition. Prog Cardiovasc Dis. 2009 May-Jun;51(6):460-71. doi: 10.1016/j.pcad.2008.08.006.
Results Reference
background
PubMed Identifier
19102740
Citation
Chan KM, Wage R, Symmonds K, Rahman-Haley S, Mohiaddin RH, Firmin DN, Pepper JR, Pennell DJ, Kilner PJ. Towards comprehensive assessment of mitral regurgitation using cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2008 Dec 22;10(1):61. doi: 10.1186/1532-429X-10-61.
Results Reference
background
PubMed Identifier
23136163
Citation
Chan KM, Punjabi PP, Flather M, Wage R, Symmonds K, Roussin I, Rahman-Haley S, Pennell DJ, Kilner PJ, Dreyfus GD, Pepper JR; RIME Investigators. Coronary artery bypass surgery with or without mitral valve annuloplasty in moderate functional ischemic mitral regurgitation: final results of the Randomized Ischemic Mitral Evaluation (RIME) trial. Circulation. 2012 Nov 20;126(21):2502-10. doi: 10.1161/CIRCULATIONAHA.112.143818. Epub 2012 Nov 7.
Results Reference
result

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Randomised Ischaemic Mitral Evaluation (RIME) Trial

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