Surgical Strategies in Moderate Ischemic Mitral Insufficiency in Patients Undergoing Coronary Artery Bypass Graft

NCT04279678 | Unknown

• 1 other identifier: Moderate ischemic MR
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Moderate Ischemic Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• 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.

  post operative ECHO assessment after 6 months.

Study Arms (2)

patients undergone mitral repair

includes all patients undergone repair of mitral valve with CABG

Procedure: Mitral valve repair

patients with no mitral repair

includes all patients where no repair done for mitral valve , only CABG

Interventions

Mitral valve repair PROCEDURE

surgical repair of moderate ischemic mitral regurgitation using pericardial patch or rigid semi-annular ring

Also known as: coronary artery bypass grafting

patients undergone mitral repair

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university Hospital

Asyut, 71515, Egypt

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Interventions

Mitral Valve Annuloplasty; Coronary Artery Bypass

Intervention Hierarchy (Ancestors)

Cardiac Valve Annuloplasty; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures; Myocardial Revascularization; Vascular Grafting; Vascular Surgical Procedures

Study Officials

• Mohamad Z Roushdi, PhD

  Mzidane

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamad Z Roushdi, PhD

CONTACT

+201006743140; mzidane89@gmail.com

Ahmad M Kamal, Professor

CONTACT

+201112743943; aelminshawy@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 21, 2020
• Study Start: March 1, 2020
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 24, 2020

Record last verified: 2020-02

Locations

EG (1)