Acute Myocardial Infarction
Conditions
Keywords
Peripheral Blood Stem Cell Treatment, Acute Myocardial Infarction
Brief summary
This study will evaluate the efficacy and safety of Therapeutic Use of Autologous-Primed Autologous Peripheral Blood Stem Cell Treatment for Myocardial Regeneration in Acute Myocardial Infarction.
Detailed description
Patients diagnosed with acute myocardial infarction will receive percutaneous coronary intervention to the culprit coronary artery according to standard procedures. For peripheral blood stem cell mobilization, Granulocyte colony-stimulating factor (G-CSF) and erythropoietin (EPO) will be injected for a total of 4 days, followed by collection of mobilized peripheral blood stem cell (mobPBSC) via apheresis. In ex-vivo setting, mobPBSC will be primed with angiopoietin 1 (Ang1) for 1 hour. A total of 2 X109 Ang1 primed mobPBSC will be injected to the culprit artery.
Interventions
BIOLOGICALAutologous Peripheral Blood Stem Cell injection
For peripheral blood stem cell mobilization, G-CSF and EPO will be injected for a total of 4 days, followed by collection of mobPBSC via apheresis. In ex-vivo setting, mobPBSC will be primed with Ang1 for 1 hour. A total of 2 X109 Ang1 primed mobPBSC will be injected to the culprit artery.
Sponsors
Seoul National University Hospital
Seoul National Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a single arm, open label interventional study
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Male and female aged ≥19 years and ≤ 80 years * 2\. A clinical diagnosis of acute myocardial infarction within 4 weeks from randomization * 3\. Successful percutaneous coronary intervention to the target lesion (TIMI flow grade 3 and residual stenosis \<30% at the target lesion) with a drug-eluting stent and/or drug-eluting balloon * 4\. Agreement to give written informed consent.
Exclusion criteria
1. Patients with uncontrolled heart failure (Killip class ≥ grade 2, or left ventricular ejection fraction \<20%) 2. Patients with uncontrolled chest pain due to ischemia 3. Patients with uncontrolled arrythmia 4. Active malignancy, or incompletely treated malignancy 5. Active infectious disease 6. Uncontrolled hematologic disease, including coagulopathy or bleeding diathesis 7. Presence of non-cardiac comorbidity with life expectancy ≤1 year from randomization 8. Females with childbearing potential or breast-feeding 9. Refusal to give written informed consent 10. Other conditions that may result in protocol non-compliance by the committees
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular systolic function | 12 months after treatment | Left ventricular ejection fraction measured by echocardiography (measured in percent) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| B-natriuretic peptide level | 12 months after treatment | Laboratory test which is measured in picograms per milliliter (pg/ml). |
| 6-minute walk test | 12 months after treatment | 6-minute walk test is measured in meters. |
| All-cause death | 12 months after treatment | Rate of patients with a mortality event due to any cause |
| Regional wall motion score index | 12 months after treatment | Regional wall motion score index measured by echocardiography. The score is scaled from 1.0 to 4.0. Using a standard transthoracic echocardiography sequence, each one of the 16 myocardial segments are assigned a score from 1 to 4. The scores for 16 segments are scaled as normokinesia (1 point) or hypokinesia (2 points) or akinesia (3 points) or dyskinesia (4 points). A score of 1.0 is considered normokinetic, and a score of 3.0 correlated as akinetic. |
| Readmssion | 12 months after treatment | Rate of patients who were readmitted due to any cause |
| Cardiovascular death | 12 months after treatment | Rate of patients with a mortality event due to cardiovascular cause |
| non-Target lesion Revascularization | 12 months after treatment | Rate of patients who received additional revascularization for a non-target lesion (the coronary lesion that was NOT treated at the index procedure) |
| Target lesion Revascularization | 12 months after treatment | Rate of patients who received additional revascularization for the target lesion (the coronary lesion that was treated at the index procedure) |
Countries
South Korea
Contacts
Primary ContactJeehoon Kang, MD
Outcome results
None listed