Transepicardial With Transseptal Autologous CD 133+ Bone Marrow Cell Implantation in Patient Following CABG Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02870933|
Recruitment Status : Completed
First Posted : August 17, 2016
Last Update Posted : November 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Biological: Transepicardial with Transseptal CD 133+ Implantation||Phase 4|
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.
Myocardial perfusion reserve index will be measure using MRI. MPRI value will be obtained globally and segmentally in each 16 ventricle segments VEGF plasma level will be measured using sandwich Enzyme-linked Immunosorbent Assay method.
Ejection fraction, left ventricle dimension, and scar size will be measured using MRI.
Quality of life will be measured using Minnesota Living With Heart Failure Questionnaire.
Statistical analysis is done using IBM SPSS Statistics version 21.0 (SPSS inc, Chicago, IL, USA). Numerical data will be presented in either mean/standard deviation or median/min-max depend on distribution of data. Hypothesis test for numeric variable is done using paired/non-paired T test or Mann-Whitney/Wilcoxon depend on normality of data. Normality test is done using Shapiro-Wilk test. Hypothesis test for category varible is done using chi-square or fischer test.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Transepicardial With Transseptal Autologous CD 133+ Bone Marrow Cell Implantation to Myocardial Perfusion in Patient Following Coronary Artery Bypass Grafting|
|Study Start Date :||January 2016|
|Actual Primary Completion Date :||May 2018|
|Actual Study Completion Date :||May 2018|
this arm will receive Transepicardial with Transseptal CD 133+ Implantation
Biological: Transepicardial with Transseptal CD 133+ Implantation
Transepicardial with Transseptal CD 133+ Implantation
No Intervention: control
this arm will not receive Transepicardial with Transseptal CD 133+ Implantation
- Myocardial perfusion [ Time Frame: 6 months ]Measured using myocardial perfusion reserve index
- Left ventricle ejection fraction [ Time Frame: 6 months ]
- Quality of life [ Time Frame: 6 months ]Quality of life will be measured using Minnesota Living With Heart Failure Questionnaire
- Wall motion abnormality [ Time Frame: 6 months ]Wall motion abnormality will be measured using Wall Motion Score Index
- scar size [ Time Frame: 6 months ]
- VEGF plasma level [ Time Frame: 6 months ]VEGF plasma level will be measured using sandwich ELISA method
- Left ventricle dimension [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02870933
|National Cardiovascular Center Harapan Kita|
|Jakarta, DKI Jakarta, Indonesia, 11420|
|Principal Investigator:||Tri Wisesa Soetisna, MD, MHA||National Cardiovascular Center Harapan Kita|