Clinical trial NCT03525041: Mitral Valve Repair Combined Coronary Artery Bypass Grafting(CABG) Verus CABG Alone on Functional Ischemic Mitral Regurgitation
Official title: The Randomly Controlled Trial of Optimal Surgical Method for CAD Patients Combined Moderate Functional Ischemic Mitral Regurgitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Mitral Valve Insufficiency
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Science & Technology Commission
First posted: 2018-05-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Left Ventricular End Systolic Volume Index (LVESVI)
timeFrame: Measured at month 12
Secondary outcomes:
measure: Operative death
timeFrame: Measured during operation
measure: In-hospital death
timeFrame: 1 year
measure: Short-term complications
timeFrame: Measured within 1 week after operation
measure: Rehospitalization
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: Ran Dong, MD
role: STUDY_CHAIR
References: