Multicenter double blind trial of autologous bone marrow mononuclear cell transplantation through intracoronary injection post acute myocardium infarction - MiHeart/AMI study.
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 x 106 MC suspended in saline with 5% autologous serum in the culprit vessel, while the latter will receive placebo (saline with 5% autologous serum).


CONCLUSIONS
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.


BACKGROUND
This trial is registered at the NIH registry under the number NCT00350766.
Dohmann
Hans F R
HF
Departamento de Pesquisa Clínica, Centro de Ensino e Pesquisa do Pró-Cardíaco/PROCEP, Rio de Janeiro, Brasil. diretoria.cientifica@procardiaco.com.br
Silva
Suzana A
SA
Sousa
André L S
AL
Braga
Alcione M S
AM
Branco
Rodrigo V C
RV
Haddad
Andréa F
AF
Oliveira
Mônica A
MA
Moreira
Rodrigo C
RC
Tuche
Fabio A A
FA
Peixoto
Cíntia M
CM
Tura
Bernardo R
BR
Borojevic
Radovan
R
Ribeiro
Jorge P
JP
Nicolau
José C
JC
Nóbrega
Antonio C
AC
Carvalho
Antonio C C
AC