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临床试验/NCT03525041
NCT03525041Unknown不适用

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

Beijing Anzhen Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
Left Ventricular End Systolic Volume Index (LVESVI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • CAD that is amenable to CABG and a clinical indication for revascularization
  • 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%
  • Age ≥ 18 years
  • Mitral valve annuloplasty is applicable

排除标准

  • Organic mitral insufficiency caused by rupture of papillary muscle, rheumatic fever, degeneration or infectious endocarditis
  • Jet area of mitral valve cannot be evaluated by echocardiogram
  • In combination of other procedures such as surgery on tricuspid valve, aortic valve, congenital heart diseases or diseases of the thoracic arteries
  • Prior surgical or percutaneous mitral valve repair
  • Contraindication to cardiopulmonary bypass (CPB)
  • Clinical signs of cardiogenic shock at the time of randomization
  • Treatment with medication prior to the surgery
  • Severe, irreversible pulmonary hypertension in the judgment of the investigator
  • Evidence of cirrhosis or liver synthetic failure
  • 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

研究组 & 干预措施

CABG+mitral valve annuloplasty

Active Comparator

Participants will undergo CABG and mitral valve annuloplasty.

干预措施: CABG (Procedure)

CABG+mitral valve annuloplasty

Active Comparator

Participants will undergo CABG and mitral valve annuloplasty.

干预措施: mitral valve annuloplasty (Procedure)

CABG

Active Comparator

Participants will undergo CABG only.

干预措施: CABG (Procedure)

结局指标

主要结局

Left Ventricular End Systolic Volume Index (LVESVI)

时间窗: Measured at month 12

次要结局

  • In-hospital death(1 year)
  • Operative death(Measured during operation)
  • Rehospitalization(1 year)
  • Short-term complications(Measured within 1 week after operation)

研究者

发起方
Beijing Anzhen Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dong Ran

chief of ward No.11,cardiac surgery

Beijing Anzhen Hospital

研究点 (1)

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