jRCT2033210163进行中(未招募)不适用
A phase I/II study of human induced Pluripotent Stem (iPS) cell-derived cardiomyocyte spheroids in patients with severe heart failure, secondary to ischemic heart disease, undergoing coronary artery bypass grafting (LAPiS Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 10
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 80age old under(—)
- 性别
- All
入选标准
- •Patients with ischemic heart disease undergoing CABG
- •Patients with resting left ventricular ejection fraction (from 0.15 to 0.40) based on institutional assessment on either screening cardiac MRI or echocardiographic assessment
- •New York Heart Association Class II, III or IV
排除标准
- •Patients who are candidates for cardiovascular surgery other than CABG (such as valvular heart surgery)
- •Patients with the following complications
- •Pulmonary hypertension, hypertension, diabetes, liver dysfunction, liver dysfunction, gait disturbance, active infection, active bleeding
结局指标
主要结局
-
Safety
次要结局
未报告次要终点
研究者
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