Study protocol

Multicenter double blind trial of autologous bone marrow mononuclear cell transplantation through intracoronary injection post acute myocardium infarction – MiHeart/AMI study

Hans FR Dohmann¹ , Suzana A Silva² , André LS Sousa¹ , Alcione MS Braga¹ , Rodrigo VC Branco¹ , Andréa F Haddad³ , Mônica A Oliveira¹ , Rodrigo C Moreira³ , Fabio AA Tuche¹ , Cíntia M Peixoto³ , Bernardo R Tura⁴ , Radovan Borojevic⁵ , Jorge P Ribeiro⁶ , José C Nicolau⁷ , Antonio C Nóbrega¹ and Antonio CC Carvalho⁴

¹  Departamento de Pesquisa Clínica, Centro de Ensino e Pesquisa do Pró-Cardíaco/PROCEP, Rio de Janeiro, Brasil

²  Departamento de Administração e Planejamento em Saúde, Escola Nacional de Saúde Pública Sérgio Arouca/FioCruz, Rio de Janeiro, Brasil

³  Departamento de Clínica Médica, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brasil

⁴  Departamento de Pesquisa Clínica, Instituto Nacional de Cardiologia/INC, Rio de Janeiro, Brasil

⁵  Departamento de Embriologia e Histologia, Universidade Federal do Rio de Janeiro, Brasil

⁶  Departamento de Cardiologia, Hospital de Clínicas de Porto Alegre, Rio Grande do Sul, Brasil

⁷  Departamento de Cardiologia, Instituto do Coração (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brasil

author email corresponding author email

Trials 2008, 9:41doi:10.1186/1745-6215-9-41

Published:	3 July 2008

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.