Mitral Valve InsufficiencyNCT06408779
Study on Surgical Treatment Strategies for Moderate Ischemic Mitral Regurgitation
An observational study of Mitral Valve Insufficiency and Mitral Valve Annuloplasty, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This study aimed to compare the efficacy of isolated coronary artery bypass grafting and coronary artery bypass grafting + mitral valve repair in moderate ischemic mitral regurgitation patients through a cohort and explore the potential risk factors of the clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Insufficiency, Mitral Valve Annuloplasty, Coronary Artery Bypass
- What is being tested?
- mitral valve repair
- Type of treatment
- Surgery or procedure
- How many people
- 464 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 1 Apr 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: adult coronary artery disease patients complicated with moderate ischemic mitral regurgitation undergoing coronary artery bypass grafting with or without mitral valve repair from August 2009 to August 2023 were enrolled
Who may be able to join
- Adult coronary artery disease patients complicated with moderate ischemic mitral regurgitation.
- undergoing coronary artery bypass grafting with or without mitral valve repair.
Who cannot join
- patients under the age of 18 years,
- patients complicated with more than moderate ischemic mitral regurgitation or undergoing mitral valve replacement,
- patients complicated with primary mitral valve disease other than ischemic mitral regurgitation, such as rheumatic mitral regurgitation or mitral valve leaflet prolapse,
- patients undergoing concomitant aortic valve procedure.
Trial locations and contacts
1 site in 1 country.
China1 site
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
About this study
This study aimed to compare the efficacy of isolated coronary artery bypass grafting and coronary artery bypass grafting + mitral valve repair in moderate ischemic mitral regurgitation patients through a cohort and explore the potential risk factors of the clinical outcomes.
- Being tested
- mitral valve repair
- Medical subject headings
- 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
coronary artery bypass grafting concomitant mitral valve repair
| Study group | Role | What they receive |
|---|---|---|
| coronary artery bypass grafting | Not described Receives: Procedure: mitral valve repair | |
| coronary artery bypass grafting concomitant mitral valve repair | Not described Receives: Procedure: mitral valve repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiovascular and cerebrovascular events
the composite of all-cause death, rehospitalization for heart failure, non-fatal myocardial infarction, non-fatal stroke or repeat mitral valve surgery.
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start1 Aug 2023
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
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.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 464 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408779
- Sponsor's protocol ID
- m_IMR_2024
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Surgical Treatment Strategies for Moderate Ischemic Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT06408779
- Acronym / sponsor ID
- m_IMR_2024
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 464 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 10 May 2024 (actual)
- 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.
This study aimed to compare the efficacy of isolated coronary artery bypass grafting and coronary artery bypass grafting + mitral valve repair in moderate ischemic mitral regurgitation patients through a cohort and explore the potential risk factors of the clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| coronary artery bypass grafting | – | Procedure: mitral valve repair |
| coronary artery bypass grafting concomitant mitral valve repair | – | Procedure: mitral valve repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult coronary artery disease patients complicated with moderate ischemic mitral regurgitation undergoing coronary artery bypass grafting with or without mitral valve repair from August 2009 to August 2023 were enrolled
Key inclusion criteria (2 listed)
- Adult coronary artery disease patients complicated with moderate ischemic mitral regurgitation.
- undergoing coronary artery bypass grafting with or without mitral valve repair.
Key exclusion criteria (4 listed)
- patients under the age of 18 years,
- patients complicated with more than moderate ischemic mitral regurgitation or undergoing mitral valve replacement,
- patients complicated with primary mitral valve disease other than ischemic mitral regurgitation, such as rheumatic mitral regurgitation or mitral valve leaflet prolapse,
- patients undergoing concomitant aortic valve 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 repaircoronary artery bypass grafting concomitant mitral valve repair | Procedure or surgery | coronary artery bypass grafting, coronary artery bypass grafting concomitant mitral valve repair |
Primary outcome
major adverse cardiovascular and cerebrovascular events
Time frame: 2years
the composite of all-cause death, rehospitalization for heart failure, non-fatal myocardial infarction, non-fatal stroke or repeat mitral valve surgery.
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 16 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Valve Insufficiency and Mitral Valve Annuloplasty, run by China National Center for Cardiovascular Diseases at 1 site in China.
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 4 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 16 May 2024. 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 China. 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?
major adverse cardiovascular and cerebrovascular events (time frame: 2years). 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 16 May 2024.