Randomized Evaluation of Mitral Annuloplasty During Coronary Artery Bypass Grafting for Moderate Functional Ischaemic Mitral Regurgitation.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 9
- 主要终点
- Functional capacity
研究概览
简要总结
The study is a randomised controlled trial comparing two treatment strategies for patients with moderate functional ischaemic mitral regurgitation undergoing coronary artery bypass grafting (CABG). Patients will be randomised to receive either CABG alone or CABG plus mitral annuloplasty. The objective of the study is to determine if mitral annuloplasty in addition to CABG improves outcome in patients with moderate functional ischaemic mitral regurgitation.
详细描述
70 patients with moderate functional ischaemic MR who are undergoing CABG will be recruited. Patients will be randomised to undergo either CABG alone or CABG combined with mitral annuloplasty. Patients will be investigated at baseline, 3 months and 1 year after surgery to determine functional capacity, quality of life, and cardiac function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing CABG.
- •Patients with moderate functional ischaemic mitral regurgitation without leaflet prolapse.
排除标准
- •Patients with severe LV dysfunction (EF less than 30%).
- •Patients with associated significant aortic valve disease.
- •Patients with significant co-morbidities: renal impairment (creatinine > 160), liver impairment (INR > 2.0, bilirubin > 40), or underlying chronic obstructive lung disease (FEV1:FVC ratio < 0.6).
- •Patients with NYHA class IV symptoms, unstable angina, acute pulmonary oedema or cardiogenic shock.
- •Patients unsuitable for surgery e.g. patients with advanced malignancy, unable to give informed consent.
- •Patients with structural abnormalities of the mitral valve e.g. papillary muscle rupture, chordal rupture, etc.
- •Patients with associated conditions which would significantly increase the risk of surgery.
- •Patients who have had previous cardiac surgery.
- •Patients with a previous history of endocarditis
研究组 & 干预措施
CABG + Mitral valve repair
干预措施: CABG + Mitral valve annuloplasty (Procedure)
CABG only
干预措施: CABG (Procedure)
结局指标
主要结局
Functional capacity
时间窗: 1 year
次要结局
- Left ventricular volumes(1 year)
- Mitral regurgitation grade(1 year)
- Neurohormonal levels(1 year)