The Effect of Transepicardial Augmentation on Transseptal Autologous CD 133+ Bone Marrow Cell Implantation to Myocardial Perfusion in Patient Following Coronary Artery Bypass Grafting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Myocardial Defect Perfusion
研究概览
简要总结
Heart Failure has several etiologies and one of them is coronary artery disease. Coronary artery bypass grafting (CABG) is one of revascularizations method which has been used for decades in coronary artery disease theraphy. However, data about coronary artery bypass grafting shows that post-CABG patients still have low ejection fraction. For the last decade, there have been a lot of studies about the using of stem cells to increase heart contractility and reverse the heart remodelling process. In this study, we use CD 133+ bone marrow stem cells which has been proved to have higher angiogenesis potential. The stem cells is given during CABG by injection transepicardial and transseptal. The purpose of this study is to determine whether transpicardial and transseptal injection of CD 133+ bone marrow stem cells can improve myocardial perfusion in patient with low ejection fraction following CABG surgery.
详细描述
Study sample : patient with low ejection fraction indicated for CABG surgery in NCCHK who fulfill inclusion and exclusion criteria
Sampling method : first we use consecutive method to find subject with male sex and age 40-70. After that, we use simple random sampling to allocate each subject to each group.
Total samples is 13 for each group. To anticipated drop out rate 10%, total sample is 15 for each group.
Intervention and measurement :
Control group will only receive CABG surgery. Study group will receive CBAG surgery and stem cell implantation. Stem cell aspiration will be performed 1 day before CABG procedure. Before aspiration, patients will be given local anesthetic and light sedation. Stem cell will be collected from posterior iliac crest. Total aspirate 190 cc. Stem cell CD133+ will be separated using CliniMACS® Magnetic Separation Device after labelled with Magnetic microbeads - anti CD133 labelling.
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
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with coronary artery disease 3 vessels disease indicated for CABG
- •LVEF < 35% which has been confirmed by MRI
- •Patients with akinetic or hypokineic segment, and left ventricle myocardial hypoperfusion confirmed in MRI
- •has signed informed consent
排除标准
- •Emergency CABG Ungraftable coronary artery Acute myocardial Infarct (<14 days) Valve disease which need surgery repair Contraindicated for MRI High degree ventricular arrhytmia Coagulation disorder HIV positive patient, Hepatitis B + patients, HCV + patients AST/ALT > 1,5 upper normal value Creatinine > 2 g/dl. Malignancy
- •Drop out criteria :
- •Aortic cross clamp >120 minutes and CABG total time >180
结局指标
主要结局
Myocardial Defect Perfusion
时间窗: Baseline, 6 months
Number of heart wall segments with perfusion defect measured by MRI.
Left Ventricular Ejection Fraction
时间窗: Baseline, 6 months
Left ventricular ejection fraction (LVEF) measured by MRI. Normal range of LVEF ranges from 50% to 70%. Borderline LVEF ranges from 41% to 49% Reduced LVEF ranges \< 41%
次要结局
- Vascular Endothelial Growth Factor(Baseline, 6 months)
- Minnesota Living With Heart Failure Questionnaire(Baseline, 6 months)
- Wall Motion Score Index(Baseline, 6 months)
- Left Ventricle End Systolic Volume(Baseline, 6 months)
- Six Minutes Walking Test(Baseline, 6 months)
- Myocardial Scar Size(Baseline, 6 months)
- Left Ventricle End Diastolic Volume(Baseline, 6 months)
研究者
Tri Wisesa Soetisna, MD, MHA
Director of Human Capital and General Affairs of National Cardiac Center
National Cardiovascular Center Harapan Kita Hospital Indonesia