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| Name | Class |
|---|---|
| Finabiotech | UNKNOWN |
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The purpose of this study is compare the improvement in global and regional cardiac function measured by echocardiography and magnetic resonance in patients with old myocardial infarction subject to cardiac catheterisation with percutaneous endocavity implantation of autologous myoblasts.
Ischaemic heart disease is one of the main causes of mortality and morbidity. In particular, myocardial infarction (MI) is of special significance, as the heart muscle cannot regenerate so a region's necrosis leads to the formation of a fibrous scar. In the last few years, new treatments have been developed for the acute phase of myocardial infarction.We have managed to slow down disease progression with these new treatments, but it continues to the development of end stage heart failure. This study tries to determine the benefit of cell cardiomyoplasty with autologous myoblasts in patients with old MI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Skeletal myoblasts | Experimental | Percutaneous autologous myoblast implantation |
|
| No cells | Placebo Comparator | Percutaneous culture medium without cells implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous autologous myoblast implantation | Procedure | Endocavity implantation of autologous myoblasts |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ejection fraction and wall motion score index measured with M-mode and echocardiography | 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Wall motion score index measured with echocardigraphy and magnetic resonance in the ITT population | 12 month after surgery | |
| Viability measured with echocardigraphy and magnetic resonance in the ITT population | 12 month after surgery |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felipe Prósper, MD, Ph.D. | Clínica Universidad de Navarra | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Gregorio Marañón | Madrid | Madrid | 28007 | Spain | ||
| Clínica Universitaria de Navarra |
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| Cardiac revascularization | Procedure | Cardiac revascularization |
|
| Incidence of cardiac arrythmias in the ITT population | 12 month after surgery |
| Ejection fraction measured with echocardiography in the ITT population | 12 month after surgery |
| Pamplona |
| Navarre |
| 31008 |
| Spain |
| ID | Term |
|---|---|
| D064987 | Cell- and Tissue-Based Therapy |
| D009204 | Myocardial Revascularization |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |
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