NCT01368575Unknown4 期
The Effect of Different Surgical Methods in the Treatment of Patients With Ischemic Mitral Regurgitation and Assess the Dynamics of Heart Failure and the Effectiveness of Surgical Treatment of Mitral Valve.
Meshalkin Research Institute of Pathology of Circulation2 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2011年5月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 420
- 试验地点
- 2
- 主要终点
- Assess the degree of mitral regurgitation in the early and late term of the study. Identify the cause of the return of IMR. Determine the dynamics of heart failure in patients with IMR.
研究概览
简要总结
The primary objective is to estimate surgical treatment (prosthesis or plastic) of moderate and severe ischemic mitral regurgitation combined with CABG in patients with CAD and impact on heart failure and progress of mitral regurgitation.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is a male or female between 30 to 75 years of age (inclusive) on the day of signing the informed consent.
- •Patients with a verified diagnosis of CAD, including post myocardial infarction scar.
- •Coronary artery pathology to be coronary artery bypasses grafting.
- •The presence of moderate or severe ischemic mitral regurgitation.
排除标准
- •The patient did not sign the informed consent.
- •Aortic valve disease requiring prosthetic or aortic valve repair.
- •Organic lesion of valve and subvalvular structures (endocarditis and degenerative processes of the mitral valve).
- •а) separation of the mitral valve chords; б) rupture and perforation of the mitral valve; в) myxomatous degeneration and calcification of the mitral valve
- •Patients with acute coronary syndrome.
- •The presence of the indications for angioplasty of the coronary arteries.
- •Coronary artery bypasses grafting in history.
- •Parallel patient participation in other studies.
- •The organs diseases, which can be reason to death after surgery during the first 3 years.
结局指标
主要结局
Assess the degree of mitral regurgitation in the early and late term of the study. Identify the cause of the return of IMR. Determine the dynamics of heart failure in patients with IMR.
时间窗: 3,6,12,24,36 months
次要结局
- Assessment of IMR(3 years)
研究者
研究点 (2)
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