Mitral Valve InsufficiencyPhase 4TIMENCT01368575
Surgical Treatment of Ischemic Mitral Regurgitation
A Phase 4 study testing CABG, CABG combined with MV repair with remodeling annuloplasty rigid ring and CABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatus in people with Mitral Valve Insufficiency, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
The primary objective is to estimate surgical treatment (prosthesis or plastic) of moderate and severe ischemic mitral regurgitation combined with CABG in patients with CAD and impact on heart failure and progress of mitral regurgitation. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Mitral Valve Insufficiency
- What is being tested?
- CABG, CABG combined with MV repair with remodeling annuloplasty rigid ring and CABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteRussia
- Study dates
- May 2011to Nov 2015
- Phase
- Phase 4
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is a male or female between 30 to 75 years of age (inclusive) on the day of signing the informed consent.
- Patients with a verified diagnosis of CAD, including post myocardial infarction scar.
- Coronary artery pathology to be coronary artery bypasses grafting.
- The presence of moderate or severe ischemic mitral regurgitation.
Who cannot join
- The patient did not sign the informed consent.
- Aortic valve disease requiring prosthetic or aortic valve repair.
- Organic lesion of valve and subvalvular structures (endocarditis and degenerative processes of the mitral valve).
- а) separation of the mitral valve chords; б) rupture and perforation of the mitral valve; в) myxomatous degeneration and calcification of the mitral valve
- Patients with acute coronary syndrome.
- The presence of the indications for angioplasty of the coronary arteries.
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- Coronary artery bypasses grafting in history.
- Parallel patient participation in other studies.
- The organs diseases, which can be reason to death after surgery during the first 3 years.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
State Research Institute of Circulation Patholody
Novosibirsk, 630055
Alexander Cherniavskiy, MD, PhD, +73833322655, amchern@mail.ru
Vidadi Efendiev, M.D, +73833322655, vidadiue@gmail.com
About this study
Official title: The Effect of Different Surgical Methods in the Treatment of Patients With Ischemic Mitral Regurgitation and Assess the Dynamics of Heart Failure and the Effectiveness of Surgical Treatment of Mitral Valve.
The primary objective is to estimate surgical treatment (prosthesis or plastic) of moderate and severe ischemic mitral regurgitation combined with CABG in patients with CAD and impact on heart failure and progress of mitral regurgitation.
- Conditions
- Mitral Valve Insufficiency
- Being tested
- CABG, CABG combined with MV repair with remodeling annuloplasty rigid ring, CABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatus, CABG and MV replacement
- Keywords
- Ischemic, Mitral, Valve, Insufficiency, SVR
- Medical subject headings
- Mitral Valve Insufficiency, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CABGProcedure or surgery
Also called will be performed only CABG (subgroup A1)
CABG
CABG combined with MV repair with remodeling annuloplasty rigid ringProcedure or surgery
CABG combined with MV repair with remodeling annuloplasty rigid ring
CABG combined with MV repair with remodeling annuloplasty rigid ringProcedure or surgery
Also called patients in subgroup B1 will receive CABG combined with MV repair with remodeling annuloplasty rigid ring
CABG combined with MV repair with remodeling annuloplasty rigid ring
CABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatusProcedure or surgery
Also called CABG grafting combined with MV repair with remodeling annuloplasty and endoventricularplasty of subvalvular
CABG combined with MV repair with remodeling annuloplasty
CABG and MV replacementProcedure or surgery
Also called patients in subgroup B3 will be performed CABG and MV replacement with preservation of subvalvular apparatus
coronary artery bypass grafting and mitral valve replacement
| Study group | Role | What they receive |
|---|---|---|
| subgroup B1 | Active comparator | subgroup B1 will receive CABG combined with MV repair with annuloplasty rigid ring Receives: Procedure: CABG combined with MV repair with remodeling annuloplasty rigid ring |
| subgroup B2 | Active comparator | B2 - CABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatus Receives: Procedure: CABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatus |
| subgroup A2 | Active comparator | CABG combined with MV repair with remodeling annuloplasty rigid ring Receives: Procedure: CABG combined with MV repair with remodeling annuloplasty rigid ring |
| subgroup A1 | Active comparator | only CABG Receives: Procedure: CABG |
| subgroup B3 | Active comparator | patients in subgroup B3 will be performed CABG and MV replacement with preservation of subvalvular apparatus Receives: Procedure: CABG and MV replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the degree of mitral regurgitation in the early and late term of the study. Identify the cause of the return of IMR. Determine the dynamics of heart failure in patients with IMR.
Measured: 3,6,12,24,36 months
Secondary outcomes (1)
Assessment of IMR
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2014
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve InsufficiencyStudies of the same condition, open and under way.
- 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Alexander Cherniavskiy, MD, PhD, Principal investigator, State Research Institute of Circulation Patholody Novosibirsk, 630055 Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368575
- Sponsor's protocol ID
- TIME-002
- Acronym
- TIME
- Status last verified
- Sep 2015
- First submitted
- 24 May 2011
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Surgical Methods in the Treatment of Patients With Ischemic Mitral Regurgitation and Assess the Dynamics of Heart Failure and the Effectiveness of Surgical Treatment of Mitral Valve.
- ClinicalTrials.gov ID
- NCT01368575
- Acronym / sponsor ID
- TIME / TIME-002
- Conditions
- Mitral Valve Insufficiency
- Keywords
- Ischemic, Mitral, Valve, Insufficiency, SVR
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- May 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Nov 2015 (estimated)
- First posted
- 8 Jun 2011 (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 primary objective is to estimate surgical treatment (prosthesis or plastic) of moderate and severe ischemic mitral regurgitation combined with CABG in patients with CAD and impact on heart failure and progress of mitral regurgitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| subgroup B1 | Active comparator | Procedure: CABG combined with MV repair with remodeling annuloplasty rigid ringsubgroup B1 will receive CABG combined with MV repair with annuloplasty rigid ring |
| subgroup B2 | Active comparator | Procedure: CABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatusB2 - CABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatus |
| subgroup A2 | Active comparator | Procedure: CABG combined with MV repair with remodeling annuloplasty rigid ringCABG combined with MV repair with remodeling annuloplasty rigid ring |
| subgroup A1 | Active comparator | Procedure: CABGonly CABG |
| subgroup B3 | Active comparator | Procedure: CABG and MV replacementpatients in subgroup B3 will be performed CABG and MV replacement with preservation of subvalvular apparatus |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is a male or female between 30 to 75 years of age (inclusive) on the day of signing the informed consent.
- Patients with a verified diagnosis of CAD, including post myocardial infarction scar.
- Coronary artery pathology to be coronary artery bypasses grafting.
- The presence of moderate or severe ischemic mitral regurgitation.
Key exclusion criteria (9 listed)
- The patient did not sign the informed consent.
- Aortic valve disease requiring prosthetic or aortic valve repair.
- Organic lesion of valve and subvalvular structures (endocarditis and degenerative processes of the mitral valve).
- а) separation of the mitral valve chords; б) rupture and perforation of the mitral valve; в) myxomatous degeneration and calcification of the mitral valve
- Patients with acute coronary syndrome.
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 |
|---|---|---|
| CABGAlso: will be performed only CABG (subgroup A1)CABG | Procedure or surgery | subgroup A1 |
| CABG combined with MV repair with remodeling annuloplasty rigid ringCABG combined with MV repair with remodeling annuloplasty rigid ring | Procedure or surgery | subgroup A2 |
| CABG combined with MV repair with remodeling annuloplasty rigid ringAlso: patients in subgroup B1 will receive CABG combined with MV repair with remodeling annuloplasty rigid ringCABG combined with MV repair with remodeling annuloplasty rigid ring | Procedure or surgery | subgroup B1 |
| CABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatusAlso: CABG grafting combined with MV repair with remodeling annuloplasty and endoventricularplasty of subvalvularCABG combined with MV repair with remodeling annuloplasty | Procedure or surgery | subgroup B2 |
| CABG and MV replacementAlso: patients in subgroup B3 will be performed CABG and MV replacement with preservation of subvalvular apparatuscoronary artery bypass grafting and mitral valve replacement | Procedure or surgery | subgroup B3 |
Primary outcome
Assess the degree of mitral regurgitation in the early and late term of the study. Identify the cause of the return of IMR. Determine the dynamics of heart failure in patients with IMR.
Time frame: 3,6,12,24,36 months
1 secondary outcome
Assessment of IMR
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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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.
Alexander Cherniavskiy, MD, PhD principal investigator
State Research Institute of Circulation Patholody Novosibirsk, 630055 Russian Federation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CABG, CABG combined with MV repair with remodeling annuloplasty rigid ring and CABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatus in people with Mitral Valve Insufficiency, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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 4 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: status not confirmed, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Cherniavskiy, MD, Prof. (+7 383 3322655, amchern@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the degree of mitral regurgitation in the early and late term of the study. Identify the cause of the return of IMR. Determine the dynamics of heart failure in patients with IMR. (time frame: 3,6,12,24,36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2015.