Myocardial Infarction
Conditions
Keywords
stem cells, acute myocardial infarction, regeneration, left ventricular ejection fraction
Brief summary
The purpose of the study is to compare the efficiency of a sorted subpopulation of CD34+/CXCR4+ cells and unselected bone marrow-derived progenitor cells in the treatment of patients with acute myocardial infarction and a low left ventricular ejection fraction.
Detailed description
Aim is to compare the efficiency of sorted subpopulation of CD34+/CXCR4+ cells and unselected bone-marrow-derived progenitor cells in treatment of patients with acute myocardial infarction and low left ventricular ejection fraction. The subpopulation of CD34+/CXCR4+ cells most likely contains the tissue-specific stem cells likely to be involved in myocardial salvage/regeneration after ischemic injury. This approach is novel and original, because so far no study identified the type of cells that actually contribute to stem cell-induced improvement in myocardial function in patients with AMI which were treated with unselected population of cells. The REGENT trial (prospective, randomized, multicentre trial comparing unselected BM mononuclear cells and sorted CD34/CXCR4+ cells in patients with myocardial infarction and low left ventricular ejection fraction) successfully treated with primary percutaneous coronary angioplasty within 12 hours after the onset of chest pain. The cells are delivered by intracoronary infusion. Efficiency is assessed by cardiac magnetic resonance imaging, echocardiography and left ventricular angiography.
Interventions
Sponsors
Ministry of Science and Higher Education, Poland
Silesian School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Acute myocardial infarction treated successfully with primary coronary angioplasty * Left ventricular ejection fraction less than 40% * Informed consent granted
Exclusion criteria
* Presence of significant coronary stenoses in non-infarct related artery requiring revascularization * Cardiogenic shock * Previous myocardial infarction * Age \< 18 years and \> 75 years * Pregnancy * Neoplasm * Contraindications for MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left ventricular ejection fraction and volumes measured by echocardiography | 6 months |
| Left ventricular ejection fraction and volumes measured by angiography | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Safety | 6, 12 months |
| Left ventricular function in dobutamine stress test | 6 months |
| Coronary flow reserve by adenosine MRI test | 6 months |
Countries
Poland
Outcome results
None listed