Phase II, Blind, Controlled, Randomised Study of the Efficacy of Percutaneous Implantation of Autologous Myoblasts in Patients With Old Infarction
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- Ejection fraction and wall motion score index measured with M-mode and echocardiography
研究概览
简要总结
The purpose of this study is compare the improvement in global and regional cardiac function measured by echocardiography and magnetic resonance in patients with old myocardial infarction subject to cardiac catheterisation with percutaneous endocavity implantation of autologous myoblasts.
详细描述
Ischaemic heart disease is one of the main causes of mortality and morbidity. In particular, myocardial infarction (MI) is of special significance, as the heart muscle cannot regenerate so a region's necrosis leads to the formation of a fibrous scar. In the last few years, new treatments have been developed for the acute phase of myocardial infarction.We have managed to slow down disease progression with these new treatments, but it continues to the development of end stage heart failure. This study tries to determine the benefit of cell cardiomyoplasty with autologous myoblasts in patients with old MI.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosis of myocardial infarction, absence of viability.
- •Ejection fraction under 40% or 45% in symptomatic patients
- •Aged from 30-80 years old.
- •Negative pregnancy test (women of childbearing age)
- •Informed consent granted
排除标准
- •Prior history of tachycardia or ventricular fibrillation (except in the acute phase of MI).
- •Myocardial infarction with more than 10 years of evolution.
- •Patients positive for HIV, HBV or HCB.
- •Patients with organ dysfunction: liver and kidney function
- •History of cancer or prior treatment with chemotherapy.
- •The patient should not suffer from any concomitant severe and/or uncontrolled medical condition.
- •Patients who, due to their geographical, psychiatric or social status, have difficulties in meeting the conditions established in the protocol.
- •Pregnant or beast feeding women.
结局指标
主要结局
Ejection fraction and wall motion score index measured with M-mode and echocardiography
时间窗: 12 months after surgery
次要结局
- Wall motion score index measured with echocardigraphy and magnetic resonance in the ITT population(12 month after surgery)
- Viability measured with echocardigraphy and magnetic resonance in the ITT population(12 month after surgery)
- Ejection fraction measured with echocardiography in the ITT population(12 month after surgery)
- Incidence of cardiac arrythmias in the ITT population(12 month after surgery)