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Transepicardial With Transseptal Autologous CD 133+ Bone Marrow Cell Implantation in Patient Following CABG Surgery

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ClinicalTrials.gov Identifier: NCT02870933
Recruitment Status : Completed
First Posted : August 17, 2016
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
Tri Wisesa Soetisna, MD, MHA, National Cardiovascular Center Harapan Kita Hospital Indonesia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Biological: Transepicardial with Transseptal CD 133+ Implantation Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: subject
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



Primary Outcome Measures :
  1. Myocardial perfusion [ Time Frame: 6 months ]
    Measured using myocardial perfusion reserve index


Secondary Outcome Measures :
  1. Left ventricle ejection fraction [ Time Frame: 6 months ]
  2. Quality of life [ Time Frame: 6 months ]
    Quality of life will be measured using Minnesota Living With Heart Failure Questionnaire

  3. Wall motion abnormality [ Time Frame: 6 months ]
    Wall motion abnormality will be measured using Wall Motion Score Index

  4. scar size [ Time Frame: 6 months ]
  5. VEGF plasma level [ Time Frame: 6 months ]
    VEGF plasma level will be measured using sandwich ELISA method

  6. Left ventricle dimension [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02870933


Locations
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Indonesia
National Cardiovascular Center Harapan Kita
Jakarta, DKI Jakarta, Indonesia, 11420
Sponsors and Collaborators
National Cardiovascular Center Harapan Kita Hospital Indonesia
Investigators
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Principal Investigator: Tri Wisesa Soetisna, MD, MHA National Cardiovascular Center Harapan Kita

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Responsible Party: Tri Wisesa Soetisna, MD, MHA, Director of Human Capital and General Affairs of National Cardiac Center, National Cardiovascular Center Harapan Kita Hospital Indonesia
ClinicalTrials.gov Identifier: NCT02870933     History of Changes
Other Study ID Numbers: LB.02.01/VII/086/KEP.007.EV
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Tri Wisesa Soetisna, MD, MHA, National Cardiovascular Center Harapan Kita Hospital Indonesia:
CD 133+
Transepicardial with Transseptal Implantation
CABG

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases