Moderate Ischemic Mitral RegurgitationNCT04279678
Surgical Strategies in Moderate Ischemic Mitral Insufficiency in Patients Undergoing Coronary Artery Bypass Graft
An observational study of Moderate Ischemic Mitral Regurgitation, run by Assiut University at 1 site in Egypt.
Trial summary
Ischemic mitral regurgitation (IMR) is a common complication of myocardial infarction, with a reported prevalence of 13-59%. Approximately one-third of these patients have at least moderate MR . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Moderate Ischemic Mitral Regurgitation
- What is being tested?
- Mitral valve repair
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2020to Dec 2023
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: study will be conducted on all patients diagnosed as ischemic heart disease with multi-vessel disease indicated for CABG with moderate degree of ischemic mitral regurgitation and meeting inclusion and exclusion criteria at duration between 2019 and 2021 at cardiothoracic surgery department in Assuit university hospital
Who may be able to join
- All patient with multi-vessel coronary artery disease with moderate degree of ischemic mitral regurgitation .
- Patient undergone surgery using cardiopulmonary bypass.
- Patient done on elective basis
Who cannot join
- CABG done by off-pump technique.
- patients not candidates for complete revascularization.
- patients with other valvular affection other than mitral valve.
- Patients done on emergency basis.
- patient known to have Rheumatic valvular heart disease.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut university Hospital
Asyut, 71515
Mohamad Z Roushdi, PhD, +201006743140, mzidane89@gmail.com
About this study
Ischemic mitral regurgitation (IMR) is a common complication of myocardial infarction, with a reported prevalence of 13-59%. Approximately one-third of these patients have at least moderate MR .
Read the detailed description
Ischemic mitral regurgitation (IMR) is a common complication of myocardial infarction, with a reported prevalence of 13-59%. Approximately one-third of these patients have at least moderate MR .
The mechanism of IMR is complex and multifactorial.IMR results from the distortion and remodeling of the left ventricle after myocardial infarction ,where the papillary muscles are displaced away from the annular plane. Coupled with annular flattening, enlargement, and decreased contraction, this spatial deformation exerts traction on the chordae tendineae, leading to mal-coaptation of the structurally normal mitral valve and subsequently to secondary MR. Furthermore, the MR-related left ventricular(LV) volume overload promotes LV remodeling, resulting in exacerbation of the MR (MR begets more MR) . Two patterns of leaflet tethering have been reported in secondary MR: asymmetric tethering and symmetric tethering. Asymmetric tethering occurs with regional LV remodeling, resulting in displacement of the posterior papillary muscle in a lateral direction. Symmetric tethering generally results from global LV remodeling, resulting in apical tethering of both the anterior and posterior papillary muscles.
Most studies show that severe IMR is not usually improved by revascularization alone and that residual MR is associated with an increased mortality risk. It is generally accepted that severe IMR should be corrected at the time of Coronary artery bypass grafting(CABG).
Surgical correction of moderate IMR at the time of coronary revascularization is still an unresolved controversy.CABG alone did reduce MR at follow-up; nevertheless, CABG alone cannot be sufficient to eliminate MR in all cases , Adding mitral valve annuloplasty to CABG may eliminate MR immediately after surgery; however, recurrent MR did occur after CABG plus mitral valve annuloplasty, and no benefit for long-term survival was observed. There was also a tendency toward higher morbidity and mortality in CABG plus mitral valve procedure as compared with CABG alone in high-risk patients with moderate IMR. The latest American Association for Thoracic Surgery (AATS)guidelines suggested that for moderate IMR, mitral valve repair with an undersized complete rigid ring annuloplasty "may be considered" during CABG surgery, but not necessarily "preferred" over revascularization alone.Therefore ,the benefits of adding mitral valve procedure to CABG for treating moderate IMR have not been clearly established.
This study is aiming to determine the short term morbidity in patients undergoing CABG alone and comparing them with patients undergoing concomitant MV repair by assessment of morbidity and mortality in both groups postoperatively .
- Conditions
- Moderate Ischemic Mitral Regurgitation
- Being tested
- Mitral valve repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitral valve repairProcedure or surgery
Also called coronary artery bypass grafting
surgical repair of moderate ischemic mitral regurgitation using pericardial patch or rigid semi-annular ring
| Study group | Role | What they receive |
|---|---|---|
| patients undergone mitral repair | includes all patients undergone repair of mitral valve with CABG Receives: Procedure: Mitral valve repair | |
| patients with no mitral repair | includes all patients where no repair done for mitral valve , only CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the outcome of mitral valve repair plus CABG vs CABG alone.
the aim is to determine whether there is significant difference postoperatively in patients undergoing mitral valve repair+CABG and those with CABG only regarding post operative degree of MR.
Measured: post operative ECHO assessment after 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study startMar 2020 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate Ischemic Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamad Zidane Roushdi, Assiut University
- Investigators
- Mohamad Z Roushdi, PhD, Principal investigator, Mzidane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279678
- Sponsor's protocol ID
- Moderate ischemic MR
- Status last verified
- Feb 2020
- First submitted
- 18 Feb 2020
- Last updated
- 24 Feb 2020
- Results posted
- No
- Individual data sharing
- Undecided
Publications
1. Magne J, Senechal M, Dumesnil JD, Pibarot P. Ischemic mitral regurgitation: a complex multifaceted disease. Cardiology.2009;112:244-59. 2. Loperfido F, Biasucci LM, Pennestri F, Laurenzi F, Gimigliano F, Vigna C, et al. Pulsed Doppler echocardiographic analysis of mitral regurgitation after myocardial infarction. Am J Cardiol.1986;58:692-7. 3. Otsuji Y, Kumanohoso T, Yoshifuku S, Matsukida K, Koriyama C, Kisanuki A, et al. Isolated annular dilatation does not usually cause important functional mitral regurgitation: comparison between patients with lone atrial fibrillation and those with idiopathic or ischemic cardiomyopathy. J Am Coll Cardiol.2002;15(39):1651-6. 4.Levine RA, Schwammenthal E. Ischemic mitral regurgitation on the threshold of a solution: from paradoxes to unifying concepts. Circulation. 2005;112:745-58. 5.Lam BK, Gilinov AM, Blackstone EH, Rajeswaran J, Yuh B, et al. Importance of ischemic mitral regurgitation. Ann Thorac Surg.2005;79:462-70. 6.Bax JJ, Braun J, Somer ST, Klautz R, Holman ER, Versteegh MI, et al. Restrictive annuloplasty and coronary revascularization in ischemic mitral regurgitation results in reverse left ventricular remodeling. Circulation. 2004;110:103-8. 7.Sandoval Y, Sorajja P, Harris KM. Contemporary management of ischemic mitral regurgitation: a review. Am J Med 2018;131: 887-95. 8.Malhotra A, Ananthanarayanan C, Wadhawa V, et al. OPCABG for moderate CIMR in elderly patients: a superior option? Braz J Cardiovasc Surg 2018; 33: 15-22. 9.Salmasi MY, Harky A, Chowdhury MF, et al. Should the mitral valve be repaired for moderate ischemic mitral regurgitation at the time of revascularization surgery? J Card Surg 2018; 33:374-84. 10.Chan KM, Punjabi PP, Flather M, et al. Coronary artery bypass surgery with or without mitral valve annuloplasty in moderate functional ischemic mitral regurgitation: final results of the Randomized Ischemic Mitral Evaluation (RIME) trial. Circulation 2012; 126: 2502-10. 11.Sun X, Huang J, Shi M, Huang G, Pang L, Wang Y. Predictors of moderate ischemic mitral regurgitation improvement after off-pump coronary artery bypass. J Thorac Cardiovasc Surg 2015; 149: 1606-12. 12.Rabbah JP, Siefert AW, Bolling SF,Yoganathan AP. Mitral valve annuloplasty and anterior leaflet augmentation for functional ischemic mitral regurgitation: quantitative comparison of coaptation and subvalvular tethering. J Thorac Cardiovasc Surg 2014;148: 1688-93. 13.Smith PK, Puskas JD, Ascheim DD, et al. Surgical treatment of moderate ischemic mitral regurgitation. N Engl J Med 2014;371: 2178-88. 14.Kron IL, LaPar DJ, Acker MA, et al. 2016 update to TheAmerican Association for Thoracic Surgery consensus guidelines:Ischemic mitral valve regurgitation. J,Thorac Cardiovasc Surg 2017; 153: 1076-9.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Strategies in Moderate Ischemic Mitral Insufficiency in Patients Undergoing Coronary Artery Bypass Graft
- ClinicalTrials.gov ID
- NCT04279678
- Acronym / sponsor ID
- Moderate ischemic MR
- Conditions
- Moderate Ischemic Mitral Regurgitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 21 Feb 2020 (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.
Ischemic mitral regurgitation (IMR) is a common complication of myocardial infarction, with a reported prevalence of 13-59%. Approximately one-third of these patients have at least moderate MR .
Detailed description
Ischemic mitral regurgitation (IMR) is a common complication of myocardial infarction, with a reported prevalence of 13-59%. Approximately one-third of these patients have at least moderate MR .
The mechanism of IMR is complex and multifactorial.IMR results from the distortion and remodeling of the left ventricle after myocardial infarction ,where the papillary muscles are displaced away from the annular plane. Coupled with annular flattening, enlargement, and decreased contraction, this spatial deformation exerts traction on the chordae tendineae, leading to mal-coaptation of the structurally normal mitral valve and subsequently to secondary MR. Furthermore, the MR-related left ventricular(LV) volume overload promotes LV remodeling, resulting in exacerbation of the MR (MR begets more MR) . Two patterns of leaflet tethering have been reported in secondary MR: asymmetric tethering and symmetric tethering. Asymmetric tethering occurs with regional LV remodeling, resulting in displacement of the posterior papillary muscle in a lateral direction. Symmetric tethering generally results from global LV remodeling, resulting in apical tethering of both the anterior and posterior papillary muscles.
Most studies show that severe IMR is not usually improved by revascularization alone and that residual MR is associated with an increased mortality risk. It is generally accepted that severe IMR should be corrected at the time of Coronary artery bypass grafting(CABG).
Surgical correction of moderate IMR at the time of coronary revascularization is still an unresolved controversy.CABG alone did reduce MR at follow-up; nevertheless, CABG alone cannot be sufficient to eliminate MR in all cases , Adding mitral valve annuloplasty to CABG may eliminate MR immediately after surgery; however, recurrent MR did occur after CABG plus mitral valve annuloplasty, and no benefit for long-term survival was observed. There was also a tendency toward higher morbidity and mortality in CABG plus mitral valve procedure as compared with CABG alone in high-risk patients with moderate IMR. The latest American Association for Thoracic Surgery (AATS)guidelines suggested that for moderate IMR, mitral valve repair with an undersized complete rigid ring annuloplasty "may be considered" during CABG surgery, but not necessarily "preferred" over revascularization alone.Therefore ,the benefits of adding mitral valve procedure to CABG for treating moderate IMR have not been clearly established.
This study is aiming to determine the short term morbidity in patients undergoing CABG alone and comparing them with patients undergoing concomitant MV repair by assessment of morbidity and mortality in both groups postoperatively .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients undergone mitral repair | – | Procedure: Mitral valve repairincludes all patients undergone repair of mitral valve with CABG |
| patients with no mitral repair | – | –includes all patients where no repair done for mitral valve , only CABG |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- study will be conducted on all patients diagnosed as ischemic heart disease with multi-vessel disease indicated for CABG with moderate degree of ischemic mitral regurgitation and meeting inclusion and exclusion criteria at duration between 2019 and 2021 at cardiothoracic surgery department in Assuit university hospital
Key inclusion criteria (3 listed)
- All patient with multi-vessel coronary artery disease with moderate degree of ischemic mitral regurgitation .
- Patient undergone surgery using cardiopulmonary bypass.
- Patient done on elective basis
Key exclusion criteria (5 listed)
- CABG done by off-pump technique.
- patients not candidates for complete revascularization.
- patients with other valvular affection other than mitral valve.
- Patients done on emergency basis.
- patient known to have Rheumatic valvular heart disease.
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 repairAlso: coronary artery bypass graftingsurgical repair of moderate ischemic mitral regurgitation using pericardial patch or rigid semi-annular ring | Procedure or surgery | patients undergone mitral repair |
Primary outcome
To compare the outcome of mitral valve repair plus CABG vs CABG alone.
Time frame: post operative ECHO assessment after 6 months.
the aim is to determine whether there is significant difference postoperatively in patients undergoing mitral valve repair+CABG and those with CABG only regarding post operative degree of MR.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Background1. Magne J, Senechal M, Dumesnil JD, Pibarot P. Ischemic mitral regurgitation: a complex multifaceted disease. Cardiology.2009;112:244-59. 2. Loperfido F, Biasucci LM, Pennestri F, Laurenzi F, Gimigliano F, Vigna C, et al. Pulsed Doppler echocardiographic analysis of mitral regurgitation after myocardial infarction. Am J Cardiol.1986;58:692-7. 3. Otsuji Y, Kumanohoso T, Yoshifuku S, Matsukida K, Koriyama C, Kisanuki A, et al. Isolated annular dilatation does not usually cause important functional mitral regurgitation: comparison between patients with lone atrial fibrillation and those with idiopathic or ischemic cardiomyopathy. J Am Coll Cardiol.2002;15(39):1651-6. 4.Levine RA, Schwammenthal E. Ischemic mitral regurgitation on the threshold of a solution: from paradoxes to unifying concepts. Circulation. 2005;112:745-58. 5.Lam BK, Gilinov AM, Blackstone EH, Rajeswaran J, Yuh B, et al. Importance of ischemic mitral regurgitation. Ann Thorac Surg.2005;79:462-70. 6.Bax JJ, Braun J, Somer ST, Klautz R, Holman ER, Versteegh MI, et al. Restrictive annuloplasty and coronary revascularization in ischemic mitral regurgitation results in reverse left ventricular remodeling. Circulation. 2004;110:103-8. 7.Sandoval Y, Sorajja P, Harris KM. Contemporary management of ischemic mitral regurgitation: a review. Am J Med 2018;131: 887-95. 8.Malhotra A, Ananthanarayanan C, Wadhawa V, et al. OPCABG for moderate CIMR in elderly patients: a superior option? Braz J Cardiovasc Surg 2018; 33: 15-22. 9.Salmasi MY, Harky A, Chowdhury MF, et al. Should the mitral valve be repaired for moderate ischemic mitral regurgitation at the time of revascularization surgery? J Card Surg 2018; 33:374-84. 10.Chan KM, Punjabi PP, Flather M, et al. Coronary artery bypass surgery with or without mitral valve annuloplasty in moderate functional ischemic mitral regurgitation: final results of the Randomized Ischemic Mitral Evaluation (RIME) trial. Circulation 2012; 126: 2502-10. 11.Sun X, Huang J, Shi M, Huang G, Pang L, Wang Y. Predictors of moderate ischemic mitral regurgitation improvement after off-pump coronary artery bypass. J Thorac Cardiovasc Surg 2015; 149: 1606-12. 12.Rabbah JP, Siefert AW, Bolling SF,Yoganathan AP. Mitral valve annuloplasty and anterior leaflet augmentation for functional ischemic mitral regurgitation: quantitative comparison of coaptation and subvalvular tethering. J Thorac Cardiovasc Surg 2014;148: 1688-93. 13.Smith PK, Puskas JD, Ascheim DD, et al. Surgical treatment of moderate ischemic mitral regurgitation. N Engl J Med 2014;371: 2178-88. 14.Kron IL, LaPar DJ, Acker MA, et al. 2016 update to TheAmerican Association for Thoracic Surgery consensus guidelines:Ischemic mitral valve regurgitation. J,Thorac Cardiovasc Surg 2017; 153: 1076-9.
- Individual participant dataSharing planned: Undecided
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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.
Mohamad Z Roushdi, PhD principal investigator
Mzidane
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 Assiut University at 1 site in Egypt.
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 5 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 24 Feb 2020. 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 Egypt. 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 Mohamad Z Roushdi, PhD (+201006743140, mzidane89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the outcome of mitral valve repair plus CABG vs CABG alone. (time frame: post operative ECHO assessment after 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04279678, which also lists 1 linked publication.
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 24 Feb 2020.