Randomised Ischaemic Mitral Evaluation (RIME) Trial

NCT00413998 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2023-03-28

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Department of Health, United Kingdom

    collaborator OTHER_GOV
  • British Heart Foundation

    collaborator OTHER
  • British Medical Association

    collaborator OTHER
  • Royal Brompton & Harefield NHS Foundation Trust

    collaborator OTHER
  • Imperial College Healthcare NHS Trust

    collaborator OTHER
  • University Hospitals, Leicester

    collaborator OTHER
  • Medical University of Silesia

    collaborator OTHER
  • University Hospitals Bristol and Weston NHS Foundation Trust

    collaborator OTHER
  • Blackpool Victoria Hospital

    collaborator OTHER
  • Imperial College London

    lead OTHER

Principal Investigators

  • John R Pepper, MChir, FRCS · Royal Brompton & Harefield NHS Foundation Trust

  • Marcus Flather, MBBS, FRCP · Royal Brompton Hospital NHS Trust, London

  • K. M. John Chan, FRCS CTh · Royal Brompton Hospital NHS Trust, London

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2012-04-30
Completion
2012-08-31

Countries

  • Poland
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00413998 on ClinicalTrials.gov