Mitral RegurgitationIMR2NCT00491452
Repair of Ischemic Mitral Regurgitation: Comparison Between Flexible and Rigid Annuloplasty Rings
An observational study of Mitral Regurgitation, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
Mitral valve repair for ischemic mitral regurgitation is performed primarily by annuloplasty. There is some degree of late failure, which may be due in part to the type of ring employed. We want to compare late results with mitral valve annuloplasty using flexible vs rigid annuloplasty rings. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mitral Regurgitation
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Apr 2007to Jul 2009
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: All patients undergoing CABG with Mitral valve repair for ischemic MR
Who may be able to join
- All patients undergoing CABG with Mitral valve repair for ischemic MR
Who cannot join
- Other valve procedures
Trial locations and contacts
1 site in 1 country.
About this study
Mitral valve repair for ischemic mitral regurgitation is performed primarily by annuloplasty. There is some degree of late failure, which may be due in part to the type of ring employed. We want to compare late results with mitral valve annuloplasty using flexible vs rigid annuloplasty rings.
- Conditions
- Mitral Regurgitation
- Keywords
- Ischemic MR, Annuloplasty
- Medical subject headings
- Mitral Valve Insufficiency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2007 (estimated)
- Study startApr 2007
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case-control
- 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
- NCT00491452
- Sponsor's protocol ID
- ISCH-MR1
- Acronym
- IMR2
- Status last verified
- May 2011
- First submitted
- 25 Jun 2007
- Last updated
- 27 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repair of Ischemic Mitral Regurgitation: Comparison Between Flexible and Rigid Annuloplasty Rings
- ClinicalTrials.gov ID
- NCT00491452
- Acronym / sponsor ID
- IMR2 / ISCH-MR1
- Conditions
- Mitral Regurgitation
- Keywords
- Ischemic MR, Annuloplasty
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Apr 2007
- Study completion
- Jul 2009 (actual)
- First posted
- 26 Jun 2007 (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.
Mitral valve repair for ischemic mitral regurgitation is performed primarily by annuloplasty. There is some degree of late failure, which may be due in part to the type of ring employed. We want to compare late results with mitral valve annuloplasty using flexible vs rigid annuloplasty rings.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients undergoing CABG with Mitral valve repair for ischemic MR
Key inclusion criteria (1 listed)
- All patients undergoing CABG with Mitral valve repair for ischemic MR
Key exclusion criteria (1 listed)
- Other valve procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 27 May 2011.
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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.
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 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 27 May 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.
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 27 May 2011.