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| ID | Type | Description | Link |
|---|---|---|---|
| PI041078 |
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| Name | Class |
|---|---|
| Hospital General Universitario Gregorio Marañon | OTHER |
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The aim of this study is to compare the effectiveness of four different strategies for preventing the ventricular postinfarction remodelling: 1) Conventional treatment for reperfunded extensive acute myocardial infarction, 2) Autologous bone marrow stem-cells intracoronary transplantation 3) mobilization of bone marrow stem-cells induced by granulocyte colony-stimulating factors (G-CSF); and 4) combined treatment (stem-cells transplantation plus mobilization with G-CSF).
This clinical study is a phase II randomized trial for patients with an acute extensive reperfunded myocardial infarction who undergo coronary artery revascularization with sirolimus coated stents. The aim of this study is to compare the effectiveness of four different strategies for preventing the ventricular postinfarction remodelling: 1) Conventional treatment for reperfunded extensive acute myocardial infarction, 2) Autologous bone marrow stem-cells intracoronary transplantation 3) mobilization of bone marrow stem-cells induced by granulocyte colony-stimulating factors (G-CSF); and 4) combined treatment (stem-cells transplantation plus mobilization with G-CSF). The investigational follow-up will be at 30 days, 4 and 9 months.Effectiveness of the therapies on neomyogenesis will be measured by Magnetic Resonance Imaging analysis of left ventricular size and global and regional function and the myocardial viability.The impact of the therapies on stent re-endothelialization and restenosis will be analysed by angiography and intracoronary ultrasounds at 30 days and 9 months. The impact of the different treatments on neoangiogenesis will be measured by infarct related artery intracoronary study of the evolution of coronary flow reserve. Also, it will be measured the haematopoietic precursors kinetic in the different treatment branches.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | standard treatment | |
| Bone marrow mononuclear progenitors | Experimental | intracoronary transplantation of bone-marrow mononuclear progenitor cells |
|
| GCSF | Experimental | progenitor cells mobilization through Granulocite- Colony Stimulating Factor treatment (G-CSF) |
|
| GCSF plus bone marrow mononuclear cells | Experimental | combined treatment (intracoronary transplantation plus cell mobilization with G-CSF). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Granulocite Colony Stimulating Factor treatment (G-CSF) | Other | G-CSF will be administered at a dose of 10 mcg/kg/day. The administration begins at the first 24 hours post-reperfusion, remaining for 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| The change in left ventricular ejection fraction and left ventricular end-systolic volume relative to baseline measured by magnetic resonance | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| The change in left ventricle end-dyastolyc volume, segment contractility, wall thickness and intravascular ultrasound reendothelization relative to baseline measured by magnetic resonance and other imaging techniques | 9 months | |
| To determine the safety of the study procedures |
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Inclusion Criteria:
Age between 18 and 75 years
Acute myocardial infarction with the following characteristics:
Akynesis or hypokinesis in infarct-related artery area without contractility abnormalities in the rest of areas.
Pharmacological, mechanical or both type reperfusions (facilitated angioplasty) with evidence of normal infarcted area epicardial flow (TIMI grade 3) in the first 24 hours after the beginning of the symptoms
Successful repair of the infarct-related artery (residual post-stenting stenosis < 30% by visual estimation with epicardial normal flow [grade 3] in the first 24 hours after the beginning of the symptoms or lack of significant residual lesions evidence (<50% visual estimation) in infarct-related artery.
Lack of evidence of significant lesions in the remaining coronary vessels or adequate revascularization achieved in the first 24 hours after symptoms began.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pedro L Sanchez, MD, PhD | Contact | 34-915865882 | pedrolsanchez@secardiologia.es | |
| Francisco Fernández-Aviles, MD, PhD | Contact | 34-915865882 | faviles@secardiologia.es |
| Name | Affiliation | Role |
|---|---|---|
| Francisco Fernandez-Aviles, MD, PhD | Hospital General Universitario Gregorio Marañón | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Valladolid | Recruiting | Valladolid | Valladolid | 47002 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26046730 | Derived | San Roman JA, Sanchez PL, Villa A, Sanz-Ruiz R, Fernandez-Santos ME, Gimeno F, Ramos B, Arnold R, Serrador A, Gutierrez H, Martin-Herrero F, Rollan MJ, Fernandez-Vazquez F, Lopez-Messa J, Ancillo P, Perez-Ojeda G, Fernandez-Aviles F. Comparison of Different Bone Marrow-Derived Stem Cell Approaches in Reperfused STEMI. A Multicenter, Prospective, Randomized, Open-Labeled TECAM Trial. J Am Coll Cardiol. 2015 Jun 9;65(22):2372-82. doi: 10.1016/j.jacc.2015.03.563. |
| Label | URL |
|---|---|
| Webmail of the TECAM group | View source |
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| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| Bone marrow mononuclear cells | Other | Bone marrow mononuclear cells will be isolated with a Ficoll technique from 50 cc of bone marrow aspiration |
|
| 12 months |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |