Myocardial Infarction
Conditions
Keywords
BMMNC, STEMI, stem cell, intracoronary delivery
Brief summary
The benefit of current reperfusion therapies for ST-elevation myocardial infarction (STEMI) is limited by post-infarction left ventricular (LV) dysfunction. Many clinic trails showed the short term outcome of bone marrow stem cell transplantation for MI patients, but rare report of long term follow-up results. Our aim was to investigate 4 years' efficacy and LV functional improvement of autologous bone marrow mononuclear cells (BMMC) transplantation in patients with ST-elevation myocardial infarction.
Detailed description
The benefit of current reperfusion therapies for ST-elevation myocardial infarction (STEMI) is limited by post-infarction left ventricular (LV) dysfunction. Many clinic trails showed the short term outcome of bone marrow stem cell transplantation for MI patients, but rare report of long term follow-up results. Aim is to evaluate the long term efficiency of unselected bone marrow mononuclear cells in treatment of patients with ST-elevation myocardial infarction (STEMI), especially with regard to the left ventricular function. The cells are delivered by intracoronary infusion 7 days after the PCI. Outcomes including LVEF, myocardial viability and coronary artery status are assessed by echocardiography, SPECT and coronary angiography.
Interventions
PROCEDUREsaline infusion
Patients receive intracoronary injections of saline 7 days after PCI.
Patients receive intracoronary injections of autologous bone marrow mononuclear cells 7 days after PCI.
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* ST segment elevation myocardial infarction, according to the WHO definition. * \<24 hour from the origin of symptoms. * Single left anterior descending coronary artery disease. * Successful revascularization of culprit lesion with PCI. * Age between 45 and 65 years old. * Written informed consent.
Exclusion criteria
* Previous MI. * Cardiomyopathy. * Atrial fibrillation or fluctuation. * Previous heart surgery. * Severe valvular heart disease. * Disease of the hematopoetic system. * NYHA functional class IV at baseline. * Severe renal, lung and liver disease or cancer. * Significant coronary lesion in one or more major coronary vessels, requiring revascularization. * Intra-cardiac thrombus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left Ventricular Ejection Fraction(LVEF) | 1, 3, 6 months, 1, 4 years |
Secondary
| Measure | Time frame |
|---|---|
| cardiac shock | 1, 3, 6 months, 1, 4 years |
| myocardial viability of the infarcted area | 1, 3, 6 months, 1, 4 years |
| in-stent restenosis | 1, 3, 6 months, 1, 4 years |
| wall motion score index(WMSI) | 1, 3, 6 months, 1, 4 years |
| cumulative MACE(including cardiac death, non-fetal myocardial infarction and target lesion revascularization) | 1, 3, 6 months, 1, 4 years |
| end-diastolic Volume/end-systolic Volume(EDV/ESV) | 1, 3, 6 months, 1, 4 years |
Countries
China
Outcome results
None listed