Randomised Ischaemic Mitral Evaluation (RIME) Trial

Coronary Artery Disease Clinical Trial

— RIME  

Official title:

Randomized Evaluation of Mitral Annuloplasty During Coronary Artery Bypass Grafting for Moderate Functional Ischaemic Mitral Regurgitation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00413998
• Other study ID #: 2006HS020B
• Secondary ID: NIHR Portfolio I
• Status: Completed
• Phase: Early Phase 1
• Start date: January 2007
• Est. completion date: August 2012

Study information

• Verified date: March 2023
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: August 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Procedure:
• CABG + Mitral valve annuloplasty
Patients will receive a mitral annuloplasty ring in addition to coronary artery bypass grafting.
• CABG
Patients will undergo coronary artery bypass grafting alone.

Locations

Country	Name	City	State
Poland	1st Dept of Cardiothoracic Surgery, Medical University of Silesia	Katowice
United Kingdom	Blackpool Victoria Hospital	Blackpool	Lancashire
United Kingdom	Bristol Heart Institute	Bristol
United Kingdom	Harefield Hospital	Harefield
United Kingdom	Glenfield Hospital, Leicester	Leicester
United Kingdom	Hammersmith Hospital	London
United Kingdom	Heart Hospital, University College Hospital	London
United Kingdom	Royal Brompton Hospital	London
United Kingdom	St. Mary's Hospital	London

Sponsors (10)

Lead Sponsor	Collaborator
Imperial College London	Blackpool Victoria Hospital, British Heart Foundation, British Medical Association, Department of Health, United Kingdom, Imperial College Healthcare NHS Trust, Medical University of Silesia, Royal Brompton & Harefield NHS Foundation Trust, University Hospitals Bristol and Weston NHS Foundation Trust, University Hospitals, Leicester

Countries where clinical trial is conducted

Poland,  United Kingdom, 

References & Publications (3)

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. — View 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 mitra — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional capacity		1 year
Secondary	Left ventricular volumes		1 year
Secondary	Mitral regurgitation grade		1 year
Secondary	Neurohormonal levels		1 year