NCT00413998

Randomised Ischaemic Mitral Evaluation (RIME) Trial

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Mitral Regurgitation
• Coronary Artery Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-01-01
• Primary completion: 2012-04-01
• Completion: 2012-08-01
• First posted: 2006-12-20
• Last updated: 2023-03-28

Locations

9 sites across 2 countries: Poland, United Kingdom