ST Elevation Myocardial Infarction
Conditions
Keywords
Umbilical Cord Mesenchymal Stem Cell, ST Elevation Myocardial Infarction, Infarct Size, Left Ventricular Ejection Fraction, IL-10, VEGF, Galectin 3, GATA-4, Beclin 1, Major Cardiac Adverse Events
Brief summary
The goal of this clinical trial is to learn about the effectiveness of Umbilical Cord Mesenchymal Stem Cell (UC MSC) therapy in patients with STEMI against infarct myocardial size reduction and prevent the incidence of heart failure in the future
Detailed description
Participants who have already done Primary Percutaneous Coronary Intervention (PCI) will be informed about the procedure and risk of this clinical trial. After written consent, 60 participants will be check for their eligibility criteria and randomized into intervention (get UC MSC transplantation) and control group. All participants will be check for their biochemical blood analysis: Interleukin-10 (IL-10), Vascular Endothelial Growth Factor (VEGF), Galectin-3, GATA Binding Protein-4 (GATA-4), and Beclin 1 (1 day before transplantation, 7 dan 14 days after transplantation); infarct size and left ventricular ejection fraction (LVEF) through Cardiac MRI (7-10 days after Primary PCI and 6 months after transplantation) and echocardiography (every month); and major adverse cardiac events/MACE (every month). The result will be access after 6 months follow up.
Interventions
BIOLOGICALUmbilical Cord Mesenchymal Stem Cell transplantation
50 million UC MSC will be transplanted 10-15 days after primary PCI
Sponsors
PT. Prodia Stem Cell Indonesia
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients with STEMI treated with primary PCI maximum 12 hours after onset of chest pain
Exclusion criteria
* Patients with history of coronary artery bypass grafting surgery * Patients with history of heart failure before admission * Patients with cardiogenic shock * Patients with cancer disease * Patients with malignant arrythmia * Patients with chronic kidney disease * Patients with haemostasis disorder * Patients with infection * Patients with stroke
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial infarct size change | 6 months | Myocardial infarct size change in percentage measure with Cardiac MRI 7-10 days after primary PCI to 6 months after UC-MSC transplantation. The method used by measuring the area of infarction in a series of slices and multiplying the area times the slice thickness to determine a volume. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left Ventricular Ejection Fraction (LVEF) with Echocardiography | 6 months | Left Ventricular Ejection Fraction (LVEF) measure with Echocardiography every month within 6 months after UC-MSC transplantation |
| Left Ventricular Ejection Fraction (LVEF) with Cardiac MRI | 6 months | Left Ventricular Ejection Fraction (LVEF) measure with Cardiac MRI every month within 6 months after UC-MSC transplantation |
| Major Cardiac Adverse Event (MACE) | 6 months | Total death, recurrent myocardial infarction, revascularization with primary PCI or Coronary Artery Bypass Graft (CABG) surgery, stroke, rehospitalisation due to heart failure, haemorrhage and arrythmia malignant assess every months within 6 months after UC-MSC transplantation |
Countries
Indonesia
Contacts
Primary ContactDede Moeswir
Outcome results
None listed