Through the injection of Hearticellgram-AMI into acute myocardial infarction patients who are the primary targets of the drug, long term efficacy in the improvement of the left ventricle ejection fraction upon the first cell treatment is to be evaluated and compared with the current existing treatments (contemporary drug treatment). This study will also compare the efficacy and safety of single dose of hearticellgram-AMI.
We are enrolling a patient who had successful conventional percutaneous coronary intervention after acute myocardial infarction. Patients are allocated to one of three groups (group1=comparator, group2= one dose of hearticellgram-AMI). single dose of hearticellgram-AMI have been attained new drug approval from MFDS (related to NCT01392105).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Kangwon National University Hospital
Chuncheon, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Yongin Severance Hospital
Gyeonggi-do, South Korea
Gachon University Gil Medical Center
LVEF amount of change
Left ventricle ejection fraction (LVEF) measured 13 months after the cell treatment (MRI measurement)
Time frame: 13 months after the cell treatment
LVEF amount of change
Left ventricle ejection fraction (LVEF) measured 6 months after the cell treatment (MRI measurement)
Time frame: 6 months after the cell treatment
Infarct size amount of change
Change in infarct size evaluated by MRI at 6 and 13 months compared to before administration
Time frame: 6, 13 months after the cell treatment
Left ventricle end systolic size change
Change in left ventricular end systolic size evaluated by MRI at 6 months and 13 months compared to before administration
Time frame: 6, 13 months after the cell treatment
Left ventricular end-diastolic size change
Change in left ventricular end diastolic size evaluated by MRI at 6 months and 13 months compared to before administration
Time frame: 6, 13 months after the cell treatment
Incidence of critical heart events
The incidence of major cardiac events (death, hospitalization for cardiac shock or heart failure, recurrence of myocardial infarction, occurrence of severe arrhythmias) within 24 months after administration
Time frame: Within 24 months after the cell treatment
Heart rate variability change amount
Heart rate variability change at 13 months compared to before administration (24 hours Holter measurement)
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Incheon, South Korea
Inha University Hospital
Incheon, South Korea
Chungnam National University Hospital
Jungnam, South Korea
Catholic University of Korea, Seoul ST. Mary's Hospital.
Seoul, South Korea
Korea University Medicine
Seoul, South Korea
Severance Hospital, Yonsei University College of Medicine
Seoul, South Korea
Wonju Severance Christian Hospital
Wŏnju, South Korea
Time frame: 13 months after the cell treatment
Left ventricular local wall movement disorder index change
The amount of change in the left ventricular local wall movement impairment index evaluated by echocardiography at 6 and 13 months compared to before administration
Time frame: 6, 13 months after the cell treatment
N-terminal pro-brain natriuretic peptide (NT-proBNP) change
Changes in N-terminal pro-brain natriuretic peptide (NT-proBNP) at 6 and 13 months compared to before administration
Time frame: 6, 13 months after the cell treatment