NCT03525041

Mitral Valve Repair Combined Coronary Artery Bypass Grafting(CABG) Verus CABG Alone on Functional Ischemic Mitral Regurgitation

The Randomly Controlled Trial of Optimal Surgical Method for CAD Patients Combined Moderate Functional Ischemic Mitral Regurgitation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Coronary artery bypass grafting(CABG) is an effective procedure in treating severe coronary artery disease(CAD). Optimal surgical method for CAD patients with functional ischemic mitral regurgitation(FIMR) is still controversial. This study will evaluate the different effectiveness of CABG plus mitral valve annuloplasty versus CABG alone on patients with moderate FIMR.

Detailed description

CAD is a severe health problem worldwide. It is a result of plaque buildup, and eventually leads to the reduction of blood supply on myocardium. CABG is one of the procedure to improve symptoms caused by myocardial ischemia. And it is especially effective in treating severe coronary artery disease. FIMR is one of the most common complications of CAD. After acute myocardial infarction, FIMR will occur in 17%-55% patients, and 3%-19% of them will develop into moderate or severe MR eventually. FIMR is an important prognostic factor of CAD, the in-hospital mortality rate of patients with IMR is significantly higher in several studies. In patients with mild MR, CABG alone is enough to improve myocardial ischemia; however, in people with moderate mitral regurgitation, there is still a dispute on whether mitral valve annuloplasty is beneficial at the time of CABG. The purpose of this study is to determine the optimal surgical procedure of CAD patients combined moderate FIMR. This study will compare the effectiveness of different surgical procedure on people with moderate FIMR by enrolling people with enrolling people with CAD who require CABG procedure and have moderate mitral regurgitation. At baseline study, a questionnaire will be assigned to undergo either CABG surgery of CABG plus mitral calve annuloplasty. Blood, urine and tissue samples will be collected after the surgery. All participants will be followed up at month 1,3,6,12, participants will take part in a medication history review, a physical examination, a blood collection to evaluate the brain natriuretic peptide and an echocardiogram.

Conditions

• Coronary Artery Disease
• Mitral Valve Insufficiency

Interventions

Type	Name	Description
PROCEDURE	CABG	CABG will be performed using standard surgical techniques. All procedures will be performed with cardiopulmonary bypass(CPB). Saphenous vein(SV)will be used as conduit but harvesting methods will not be prescribed, and utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, judging by the surgical investigator.
PROCEDURE	mitral valve annuloplasty	Surgical techniques for mitral valve annuloplasty may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation.

Timeline

• Start date: 2017-05-01
• Primary completion: 2019-12-31
• Completion: 2020-06-30
• First posted: 2018-05-15
• Last updated: 2018-05-15

Locations

1 site across 1 country: China