Moderate Ischemic Mitral RegurgitationNCT00394797
Surgical Correction of Moderate Ischemic Mitral Regurgitation
An observational study of Moderate Ischemic Mitral Regurgitation, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to try and determine whether repair of moderate ischemic mitral regurgitation at the time of coronary bypass graft surgery (CABG) has an impact on survival.We will compare patients undergoing CABG + mitral repair or CABG only groups. Primary endpoints include late survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate Ischemic Mitral Regurgitation
- What is being tested?
- mitral valve annuloplasty
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients undergoing coronary bypass surgery who have moderate degree of ischemic MR
Who may be able to join
- patients undergoing coronary bypass surgery who have moderate degree of ischemic MR
Who cannot join
- etiology of mitral regurgitation other than ischemic, degree of regurgitation other than moderate.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to try and determine whether repair of moderate ischemic mitral regurgitation at the time of coronary bypass graft surgery (CABG) has an impact on survival.We will compare patients undergoing CABG + mitral repair or CABG only groups. Primary endpoints include late survival. Secondary endpoints include event free survival, symptoms, and echocardiographic outcomes.
- Conditions
- Moderate Ischemic Mitral Regurgitation
- Being tested
- mitral valve annuloplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitral valve annuloplastyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
survival at 1,5 and 10 years
Secondary outcomes (3)
event free survival
symptoms
echocardiographic parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Ischemic Mitral RegurgitationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Shuli Silberman, MD, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394797
- Sponsor's protocol ID
- IMR001
- Status last verified
- May 2011
- First submitted
- 31 Oct 2006
- Last updated
- 1 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Correction of Moderate Ischemic Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT00394797
- Acronym / sponsor ID
- IMR001
- Conditions
- Moderate Ischemic Mitral Regurgitation
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- First posted
- 1 Nov 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 purpose of this study is to try and determine whether repair of moderate ischemic mitral regurgitation at the time of coronary bypass graft surgery (CABG) has an impact on survival.We will compare patients undergoing CABG + mitral repair or CABG only groups. Primary endpoints include late survival. Secondary endpoints include event free survival, symptoms, and echocardiographic outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing coronary bypass surgery who have moderate degree of ischemic MR
Key inclusion criteria (1 listed)
- patients undergoing coronary bypass surgery who have moderate degree of ischemic MR
Key exclusion criteria (1 listed)
- etiology of mitral regurgitation other than ischemic, degree of regurgitation other than moderate.
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 |
|---|---|---|
| mitral valve annuloplasty | Procedure or surgery | – |
Primary outcome
survival at 1,5 and 10 years
3 secondary outcomes
event free survival
symptoms
echocardiographic parameters
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 1 Jun 2011.
Related trials for Moderate Ischemic Mitral Regurgitation
RecruitingPhase 4
Treatment of Moderate Ischemic Mitral Regurgitation in Patients With Coronary Artery Disease
Coronary Artery Disease, Ischemic Mitral Regurgitation
Active, not recruitingObservational study
Long Term Follow Up for CTSN Mitral Valve Repair Studies
Mitral Valve Insufficiency, Coronary Artery Disease
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.
Shuli Silberman, MD principal investigator
Shaare Zedek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate Ischemic Mitral Regurgitation, run by Shaare Zedek Medical Center at 1 site in Israel.
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 1 inclusion and 1 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 1 Jun 2011. 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 Israel. 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.
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?
survival at 1,5 and 10 years. 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 1 Jun 2011.