Mitral RegurgitationEarly Phase 1RIMENCT00413998
Randomised Ischaemic Mitral Evaluation (RIME) Trial
A Early Phase 1 study testing CABG + Mitral valve annuloplasty and CABG in people with Mitral Regurgitation and Coronary Artery Disease, run by Imperial College London at 9 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mitral Regurgitation, Coronary Artery Disease
- What is being tested?
- CABG + Mitral valve annuloplasty and CABG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Jan 2007to Aug 2012
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing CABG.
- Patients with moderate functional ischaemic mitral regurgitation without leaflet prolapse.
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United Kingdom8 sites
Blackpool Victoria Hospital
Blackpool, Lancashire, FY3 8NR
Bristol Heart Institute
Bristol
Harefield Hospital
Harefield, UB9 6UJ
Glenfield Hospital, Leicester
Leicester, LE3 9QP
Royal Brompton Hospital
London, SW3 6NP
Hammersmith Hospital
London, W12 0HS
Heart Hospital, University College Hospital
London, W1G 8PH
St. Mary's Hospital
London, W2 1NY
Poland1 site
1st Dept of Cardiothoracic Surgery, Medical University of Silesia
Katowice
About this study
Official title: Randomized Evaluation of Mitral Annuloplasty During Coronary Artery Bypass Grafting for Moderate Functional Ischaemic Mitral Regurgitation.
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.
Read the 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
- Being tested
- CABG + Mitral valve annuloplasty, CABG
- Keywords
- Functional ischaemic mitral regurgitation
- Medical subject headings
- Mitral Valve Insufficiency, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CABG + Mitral valve annuloplastyProcedure or surgery
Patients will receive a mitral annuloplasty ring in addition to coronary artery bypass grafting.
CABGProcedure or surgery
Patients will undergo coronary artery bypass grafting alone.
| Study group | Role | What they receive |
|---|---|---|
| CABG + Mitral valve repair | Experimental | Not described Receives: Procedure: CABG + Mitral valve annuloplasty |
| CABG only | Active comparator | Not described Receives: Procedure: CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
Measured: 1 year
Secondary outcomes (3)
Left ventricular volumes
Measured: 1 year
Mitral regurgitation grade
Measured: 1 year
Neurohormonal levels
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2006 (estimated)
- Study startJan 2007
- Primary completionApr 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- John R Pepper, MChir, FRCS, Study chair, Royal Brompton & Harefield NHS Foundation TrustMarcus Flather, MBBS, FRCP, Principal investigator, Royal Brompton Hospital NHS Trust, LondonK. M. John Chan, FRCS CTh, Principal investigator, Royal Brompton Hospital NHS Trust, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413998
- Sponsor's protocol ID
- 2006HS020B
- Other IDs
- NIHR Portfolio ID 4129
- Acronym
- RIME
- Status last verified
- Mar 2023
- First submitted
- 19 Dec 2006
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19410679Chan 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.
PubMed 19102740Chan 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.
PubMed 23136163
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation of Mitral Annuloplasty During Coronary Artery Bypass Grafting for Moderate Functional Ischaemic Mitral Regurgitation.
- ClinicalTrials.gov ID
- NCT00413998
- Acronym / sponsor ID
- RIME / 2006HS020B
- Conditions
- Mitral Regurgitation, Coronary Artery Disease
- Keywords
- Functional ischaemic mitral regurgitation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- 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
- Study start
- Jan 2007
- Primary completion
- Apr 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 20 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CABG + Mitral valve repair | Experimental | Procedure: CABG + Mitral valve annuloplasty |
| CABG only | Active comparator | Procedure: CABG |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing CABG.
- Patients with moderate functional ischaemic mitral regurgitation without leaflet prolapse.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CABG + Mitral valve annuloplastyPatients will receive a mitral annuloplasty ring in addition to coronary artery bypass grafting. | Procedure or surgery | CABG + Mitral valve repair |
| CABGPatients will undergo coronary artery bypass grafting alone. | Procedure or surgery | CABG only |
Primary outcome
Functional capacity
Time frame: 1 year
3 secondary outcomes
Left ventricular volumes
Time frame: 1 year
Mitral regurgitation grade
Time frame: 1 year
Neurohormonal levels
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Background: PubMed 19410679Chan 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.
- Background: PubMed 19102740Chan 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 publication: PubMed 23136163Chan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John R Pepper, MChir, FRCS study chair
Royal Brompton & Harefield NHS Foundation Trust
Marcus Flather, MBBS, FRCP principal investigator
Royal Brompton Hospital NHS Trust, London
K. M. John Chan, FRCS CTh principal investigator
Royal Brompton Hospital NHS Trust, London
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CABG + Mitral valve annuloplasty and CABG in people with Mitral Regurgitation and Coronary Artery Disease, run by Imperial College London at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00413998, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.