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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03525041
• Other study ID #: 2015217146
• Secondary ID: Z151100003915084
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: May 2018
• Source: Beijing Anzhen Hospital
• Contact: Kui Zhang, MD
• Phone: 86-10-64456411
• Email: zhangkui725[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. CAD that is amenable to CABG and a clinical indication for revascularization

2. Moderate mitral regurgitation in the judgment of the clinical site echocardiographer, quantitative guidelines as proposed would be: jet area between 4 cmsq to 8 cmsq, jet area/left atrial area ratio between 20% to 39%

3. Age = 18 years

4. Mitral valve annuloplasty is applicable

Exclusion Criteria:

1. Organic mitral insufficiency caused by rupture of papillary muscle, rheumatic fever, degeneration or infectious endocarditis

2. Jet area of mitral valve cannot be evaluated by echocardiogram

3. In combination of other procedures such as surgery on tricuspid valve, aortic valve, congenital heart diseases or diseases of the thoracic arteries

4. Prior surgical or percutaneous mitral valve repair

5. Contraindication to cardiopulmonary bypass (CPB)

6. Clinical signs of cardiogenic shock at the time of randomization

7. Treatment with medication prior to the surgery

8. Severe, irreversible pulmonary hypertension in the judgment of the investigator

9. Evidence of cirrhosis or liver synthetic failure

10. Recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair compliance with the study, in the judgment of the investigator

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Mitral Valve Insufficiency
• Myocardial Ischemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital	Beijing Municipal Science & Technology Commission

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left Ventricular End Systolic Volume Index (LVESVI)		Measured at month 12
Secondary	Operative death		Measured during operation
Secondary	In-hospital death	death during the time of hospitalization	1 year
Secondary	Short-term complications	Postoperative perivalvular leakage or heart failure	Measured within 1 week after operation
Secondary	Rehospitalization	Re-hospitalization caused by heart failure or aggravated mitral regurgitation	1 year