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NCT Number: NCT00413998

Randomised Ischaemic Mitral Evaluation (RIME) Trial

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

1st Dept of Cardiothoracic Surgery, Medical University of Silesia, Katowice, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CABG + Mitral valve annuloplasty

Procedure

Patients will receive a mitral annuloplasty ring in addition to coronary artery bypass grafting.

CABG

Procedure

Patients will undergo coronary artery bypass grafting alone.

Primary outcomes

  1. Functional capacity

    Time frame: 1 year

Secondary outcomes

  1. Left ventricular volumes

    Time frame: 1 year

  2. Mitral regurgitation grade

    Time frame: 1 year

  3. Neurohormonal levels

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: RIME

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Dec 20, 2006
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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