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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Patients receive intracoronary injections of saline 7 days after PCI. |
|
| 2 | Experimental | Patients receive intracoronary injections of autologous bone marrow mononuclear cells 7 days after PCI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| saline infusion | Procedure | Patients receive intracoronary injections of saline 7 days after PCI. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Ejection Fraction(LVEF) | 1, 3, 6 months, 1, 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| in-stent restenosis | 1, 3, 6 months, 1, 4 years | |
| cardiac shock | 1, 3, 6 months, 1, 4 years | |
| myocardial viability of the infarcted area |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haichang Wang, MD,PHD | Xijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology in Xijing Hospital | Xi'an | Shaanxi | 710032 | China |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| autologous bone marrow mononuclear cells infusion | Procedure | Patients receive intracoronary injections of autologous bone marrow mononuclear cells 7 days after PCI. |
|
|
| 1, 3, 6 months, 1, 4 years |
| end-diastolic Volume/end-systolic Volume(EDV/ESV) | 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 |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |