| Autor: |
Borojevic Radovan, Peixoto Cíntia M, Tura Bernardo R, Tuche Fabio AA, Moreira Rodrigo C, Oliveira Mônica A, Haddad Andréa F, Branco Rodrigo VC, Braga Alcione MS, Sousa André LS, Silva Suzana A, Dohmann Hans FR, Ribeiro Jorge P, Nicolau José C, Nóbrega Antonio C, Carvalho Antonio CC |
| Jazyk: |
angličtina |
| Rok vydání: |
2008 |
| Předmět: |
|
| Zdroj: |
Trials, Vol 9, Iss 1, p 41 (2008) |
| Druh dokumentu: |
article |
| ISSN: |
1745-6215 |
| DOI: |
10.1186/1745-6215-9-41 |
| Popis: |
Abstract Background Myocardial infarction remains as a major cause of mortality worldwide and a high rate of survivors develop heart failure as a sequel, resulting in a high morbidity and elevated expenditures for health system resources. We have designed a multicenter trial to test for the efficacy of autologous bone marrow (ABM) mononuclear cell (MC) transplantation in this subgroup of patients. The main hypothesis to be tested is that treated patients will have a significantly higher ejection fraction (EF) improvement after 6 months than controls. Methods A sample of 300 patients admitted with ST elevation acute myocardial infarction (STEMI) and left ventricle (LV) systolic dysfunction, and submitted to successful mechanical or chemical recanalization of the infarct-related coronary artery will be selected for inclusion and randomized to either treated or control group in a double blind manner. The former group will receive 100 × 106 MC suspended in saline with 5% autologous serum in the culprit vessel, while the latter will receive placebo (saline with 5% autologous serum). Implications Many phase I/II clinical trials using cell therapy for STEMI have been reported, demonstrating that cell transplantation is safe and may lead to better preserved LV function. Patients with high risk to develop systolic dysfunction have the potential to benefit more. Larger randomized, double blind and controlled trials to test for the efficacy of cell therapies in patients with high risk for developing heart failure are required. Trial Register This trial is registered at the NIH registry under the number NCT00350766. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
|
Full text from SpringerLink