Coronary DiseaseNCT00443365
Should we Repair Ischemic Mitral Regurgitation?
A study testing Mitral valve repair in people with Coronary Disease and Mitral Valve Insufficiency, run by Medical University of Silesia at 1 site in Poland.
Trial summary
The purpose of this study is to assess whether adding mitral valve repair to coronary artery bypass grafting improves outcome in patients with ischemic mitral regurgitation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Disease, Mitral Valve Insufficiency
- What is being tested?
- Mitral valve repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- Mar 2007to not given
- Phase
- Interventional
- 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
- Stable coronary artery disease
- Patient accepted for coronary artery bypass surgery
- Ischemic mitral regurgitation
Who cannot join
- Acute coronary syndrome within 30 days
- Organic valvular heart disease
- Need for other than CABG and mitral valve repair cardiac surgical procedure
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
2nd Dept of Cardiac Surgery, Medical University of Silesia
Katowice, 40-635
Marek A Deja, MD PhD, 48-32-252-6093, mdeja@slam.katowice.pl
Marek A Deja, MD PhD
About this study
The purpose of this study is to assess whether adding mitral valve repair to coronary artery bypass grafting improves outcome in patients with ischemic mitral regurgitation.
- Conditions
- Coronary Disease, Mitral Valve Insufficiency
- Being tested
- Mitral valve repair
- Medical subject headings
- Coronary Disease, Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitral valve repairProcedure or surgery
mitral valve annuloplasty
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Coronary Artery Bypass Grafting with no Mitral Valve intervention |
| 2 | Active comparator | Coronary Artery Bypass Grafting + Mitral Annuloplasty Receives: Procedure: Mitral valve repair |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2007 (estimated)
- Study startMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Poland
- Investigators
- Marek A Deja, MD PhD, Principal investigator, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00443365
- Sponsor's protocol ID
- 6/252/35/3747
- Status last verified
- May 2008
- First submitted
- 2 Mar 2007
- Last updated
- 30 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Should we Repair Ischemic Mitral Regurgitation?
- ClinicalTrials.gov ID
- NCT00443365
- Acronym / sponsor ID
- 6/252/35/3747
- Conditions
- Coronary Disease, Mitral Valve Insufficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Collaborators
- Ministry of Health, Poland
- Study start
- Mar 2007
- First posted
- 6 Mar 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.
The purpose of this study is to assess whether adding mitral valve repair to coronary artery bypass grafting improves outcome in patients with ischemic mitral regurgitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Coronary Artery Bypass Grafting with no Mitral Valve intervention |
| 2 | Active comparator | Procedure: Mitral valve repairCoronary Artery Bypass Grafting + Mitral Annuloplasty |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Stable coronary artery disease
- Patient accepted for coronary artery bypass surgery
- Ischemic mitral regurgitation
Key exclusion criteria (3 listed)
- Acute coronary syndrome within 30 days
- Organic valvular heart disease
- Need for other than CABG and mitral valve repair cardiac surgical procedure
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 repairmitral valve annuloplasty | Procedure or surgery | 2 |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2008.
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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.
Marek A Deja, MD PhD principal investigator
Medical University of Silesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitral valve repair in people with Coronary Disease and Mitral Valve Insufficiency, run by Medical University of Silesia at 1 site in Poland.
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 3 inclusion and 3 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 30 May 2008. 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 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.
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 Marek A Deja, MD PhD (48-32-359-8542, mdeja@slam.katowice.pl), or a site near the patient. 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 30 May 2008.