Coronary Artery Disease Clinical Trial
Official title:
The Effect of Transepicardial Augmentation on Transseptal Autologous CD 133+ Bone Marrow Cell Implantation to Myocardial Perfusion in Patient Following Coronary Artery Bypass Grafting
Verified date | March 2020 |
Source | National Cardiovascular Center Harapan Kita Hospital Indonesia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 2019 |
Est. primary completion date | April 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Indonesia | National Cardiovascular Center Harapan Kita | Jakarta | DKI Jakarta |
Lead Sponsor | Collaborator |
---|---|
National Cardiovascular Center Harapan Kita Hospital Indonesia |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Myocardial Defect Perfusion | Number of heart wall segments with perfusion defect measured by MRI. | Baseline, 6 months | |
Primary | Left Ventricular Ejection Fraction | 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% | Baseline, 6 months | |
Secondary | Six Minutes Walking Test | Quality of life will be assessed using Six minutes walking test, to see the changes of six minutes walking test before and after intervention Distances reported for healthy individuals ages 40 yo 85 years range from 400 to 700 m.. | Baseline, 6 months | |
Secondary | Wall Motion Score Index | Cardiac wall motion abnormality will be measured using Wall Motion Score Index with MRI. Each myocardial segment is assigned a score from 1 to 4. The 16 segment model of myocardial segmentation is recommended. A WMSI of 1.0 is considered normokinetic. A WMSI of 1.5 is considered mild hypokinesia A WMSI of 2.0 is considered hypokinesia A WMSI of 2.5 is considered severe hypokinesia A WMSI of 3.0 is considered akinetic. |
Baseline, 6 months | |
Secondary | Myocardial Scar Size | Percentage of myocardial scar size proportion measured by MRI to quantify and define the extent/transmurality of scar tissue, the following definitions were used spatial (circumferential) extent, the number of affected segments nontransmurality, the number of segmments with a segmental scar score of 1 or 2, and transmurality, the number of segments with a segmental scar score of 3 or 4 total score, summed segmental scar scores per patient divided by 17 (which reflects the damage per patient) |
Baseline, 6 months | |
Secondary | Vascular Endothelial Growth Factor | Cytokine that has important role for angiogenesis. Normal range for plasma VEGF is 0-115 pg/ml | Baseline, 6 months | |
Secondary | Left Ventricle End Systolic Volume | Left ventricle end-systolic volume is the volume of blood in a left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. Normal LVESV ranges is 37 - 57 mililiters. |
Baseline, 6 months | |
Secondary | Minnesota Living With Heart Failure Questionnaire | Quality of life assessed using Minnesota Living With Heart Failure Questionnaire consist of 21 questions, to see the changes before and after intervention. Minimum score = 0, Maximum score = 105 Higher values represent a worse outcome |
Baseline, 6 months | |
Secondary | Left Ventricle End Diastolic Volume | Left ventricle end-diastolic volume is the volume of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricle just before systole. Normal ranges of LVEDV is 121 - 163 mililiters |
Baseline, 6 months |
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