NCT01394432Unknown3 期
Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction
Meshalkin Research Institute of Pathology of Circulation2 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2011年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Reduction in left ventricle systolic volume on 15% mesured by MRI
研究概览
简要总结
The investigators hypothesised that endocardial stem cells implantation following after percutaneous coronary intervention (PCI) could reduce the scar formation and increase reverse remodeling in patients with primary acute myocardial infarction.
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, Outcomes Assessor)
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
- •Patients with acute Q-wave myocardial infarction after thrombolitic therapy during 6-36 hours from the onsent of signs
- •Oclusion or significant stenosis of infarct-related left anterior descending artery (LAD)
- •Left ventricle ejection fraction (LVEF) < 50% measured by Echo
排除标准
- •Thrombolysis of pyrrolase or streptokinase
- •Surgical unsignificant stenosis of LAD
- •Indications for CABG
- •Cardiogenic shock
- •Uncontrolled hypertension
- •Thrombocytopenia
- •Ongoing bleeding
- •Anemia < 100 g/l
- •Patients, who required anticoagulation therapy at the time of inclusion
- •Obesity, BMI>40
- •Severe comorbidities
- •Unwillingness to participate
研究组 & 干预措施
Group 1 (PCI+SC implantation)
Active Comparator
Endocardial Stem cells implantation with Noga system
干预措施: PCI and Stem Cells or Placebo injections (Procedure)
Group 2 (PCI+Placebo)
Placebo Comparator
Placebo
干预措施: PCI and Stem Cells or Placebo injections (Procedure)
结局指标
主要结局
Reduction in left ventricle systolic volume on 15% mesured by MRI
时间窗: 12 months
次要结局
- number of patients with life-threatening arrhythmias(12 months)
- SPECT and Echo data(12 months)
- number of patients with thromboembolic events(12 months)
- number of heart failure hospitalizations(12 months)
- BNP level(12 months)
- All-cause death(12 months)
- Distance during 6-minute walking test(12 months)
研究者
研究点 (2)
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