José C Nicolau1, Remo H M Furtado1, Suzana A Silva2, Carlos E Rochitte3, Anis Rassi4, João B M C Moraes5, Edgard Quintella6, Costantino R Costantini7, Adrian P M Korman8, Marco A Mattos2, Hélio J Castello9, Adriano Caixeta10, Hans F R Dohmann11, Antonio C C de Carvalho2. 1. Coronary Care Unit, Instituto do Coração, Hospital das Clínicas, HCFMUSP, Universidade de São Paulo, São Paulo, Brazil. 2. Clinical Research Unit, Instituto Nacional de Cardiologia, Rio de Janeiro, Brazil. 3. Cardiovascular Imaging Department, Instituto do Coração, Hospital das Clínicas, HCFMUSP, Universidade de São Paulo, São Paulo, Brazil. 4. Division of Cardiology, Anis Rassi Hospital, Goiânia, Brazil. 5. Cardiology Department, Hospital Agamenon Magalhaes, Recife, Brazil. 6. Cardiology Department, Instituto de Cardiologia Aloysio de Castro, Rio de Janeiro, Brazil. 7. Department of Interventional Cardiology, Hospital Cardiológico Costantini, Curitiba, Brazil. 8. Cardiology Department, Sociedade Divina Providencia Hospital Santa Isabel, Blumenau, Brazil. 9. Cardiology Department, Hospital Bandeirantes, São Paulo, Brazil. 10. Department of Interventional Cardiology, Instituto do Coração do Distrito Federal, Brasília, Brazil. 11. Cardiology Department, PROCEP/Amil Assistência Médica Internacional, Rio de Janeiro, Brazil.
Abstract
BACKGROUND:Left ventricular ejection fraction (LVEF) is a major determinant of long-term prognosis after ST-segment elevation myocardial infarction (STEMI). STEMI patients with reduced LVEF have a poor prognosis, despite successful reperfusion and the use of renin-angiotensin-aldosterone inhibitors. HYPOTHESIS: Intracoronary infusion of bone marrow-derived mononuclear cells (BMMC) may improve LVEF in STEMI patients successfully reperfused. METHODS: The main inclusion criteria for this double-blind, randomized, multicenter study were patient age 30 to 80 years, LVEF ≤50%, successful angioplasty of infarct-related artery, and regional dysfunction in the infarct-related area analyzed before cell injection. Cardiac magnetic resonance imaging was used to assess LVEF, left ventricular volumes, and infarct size at 7 to 9 days and 6 months post-myocardial infarction. RESULTS:One hundred and twenty-one patients were included (66 patients in the BMMC group and 55 patients in the placebo group). The primary endpoint, mean LVEF, was similar between both groups at baseline (44.63% ± 10.74% vs 42.23% ± 10.33%; P = 0.21) and at 6 months (44.74% ± 12.95 % vs 43.50 ± 12.43%; P = 0.59). The groups were also similar regarding the difference between baseline and 6 months (0.11% ± 8.5% vs 1.27% ± 8.93%; P = 0.46). Other parameters of left ventricular remodeling, such as systolic and diastolic volumes, as well as infarct size, were also similar between groups. CONCLUSIONS: In this randomized, multicenter, double-blind trial, BMMC intracoronary infusion did not improve left ventricular remodeling or decrease infarct size.
RCT Entities:
BACKGROUND: Left ventricular ejection fraction (LVEF) is a major determinant of long-term prognosis after ST-segment elevation myocardial infarction (STEMI). STEMI patients with reduced LVEF have a poor prognosis, despite successful reperfusion and the use of renin-angiotensin-aldosterone inhibitors. HYPOTHESIS: Intracoronary infusion of bone marrow-derived mononuclear cells (BMMC) may improve LVEF in STEMI patients successfully reperfused. METHODS: The main inclusion criteria for this double-blind, randomized, multicenter study were patient age 30 to 80 years, LVEF ≤50%, successful angioplasty of infarct-related artery, and regional dysfunction in the infarct-related area analyzed before cell injection. Cardiac magnetic resonance imaging was used to assess LVEF, left ventricular volumes, and infarct size at 7 to 9 days and 6 months post-myocardial infarction. RESULTS: One hundred and twenty-one patients were included (66 patients in the BMMC group and 55 patients in the placebo group). The primary endpoint, mean LVEF, was similar between both groups at baseline (44.63% ± 10.74% vs 42.23% ± 10.33%; P = 0.21) and at 6 months (44.74% ± 12.95 % vs 43.50 ± 12.43%; P = 0.59). The groups were also similar regarding the difference between baseline and 6 months (0.11% ± 8.5% vs 1.27% ± 8.93%; P = 0.46). Other parameters of left ventricular remodeling, such as systolic and diastolic volumes, as well as infarct size, were also similar between groups. CONCLUSIONS: In this randomized, multicenter, double-blind trial, BMMC intracoronary infusion did not improve left ventricular remodeling or decrease infarct size.
Authors: José C Nicolau; Lilia N Maia; João Vítola; Vinicius D Vaz; Maurício N Machado; Moacir F Godoy; Roberto R Giraldez; José A F Ramires Journal: Am J Cardiol Date: 2003-02-15 Impact factor: 2.778
Authors: Kai C Wollert; Gerd P Meyer; Joachim Lotz; Stefanie Ringes-Lichtenberg; Peter Lippolt; Christiane Breidenbach; Stephanie Fichtner; Thomas Korte; Burkhard Hornig; Diethelm Messinger; Lubomir Arseniev; Bernd Hertenstein; Arnold Ganser; Helmut Drexler Journal: Lancet Date: 2004 Jul 10-16 Impact factor: 79.321
Authors: José Carlos Nicolau; Marcelo Franken; Paulo Andrade Lotufo; Antonio Carlos Carvalho; José Antonio Marin Neto; Felipe Gallego Lima; Oscar Dutra; Elias Knobel; Cesar Cardoso de Oliveira; Sérgio Timerman; Edson Stefanini Journal: Arq Bras Cardiol Date: 2012-04 Impact factor: 2.000
Authors: Joshua M Hare; Jay H Traverse; Timothy D Henry; Nabil Dib; Robert K Strumpf; Steven P Schulman; Gary Gerstenblith; Anthony N DeMaria; Ali E Denktas; Roger S Gammon; James B Hermiller; Mark A Reisman; Gary L Schaer; Warren Sherman Journal: J Am Coll Cardiol Date: 2009-12-08 Impact factor: 24.094
Authors: A Volpi; C De Vita; M G Franzosi; E Geraci; A P Maggioni; F Mauri; E Negri; E Santoro; L Tavazzi; G Tognoni Journal: Circulation Date: 1993-08 Impact factor: 29.690
Authors: Michał Tendera; Wojciech Wojakowski; Witold Ruzyłło; Lidia Chojnowska; Cezary Kepka; Wiesława Tracz; Piotr Musiałek; Wiesława Piwowarska; Jadwiga Nessler; Paweł Buszman; Stefan Grajek; Piotr Breborowicz; Marcin Majka; Mariusz Z Ratajczak Journal: Eur Heart J Date: 2009-02-10 Impact factor: 29.983
Authors: Alexandra N Nowbar; Michael Mielewczik; Maria Karavassilis; Hakim-Moulay Dehbi; Matthew J Shun-Shin; Siana Jones; James P Howard; Graham D Cole; Darrel P Francis Journal: BMJ Date: 2014-04-28
Authors: José C Nicolau; Remo H M Furtado; Suzana A Silva; Carlos E Rochitte; Anis Rassi; João B M C Moraes; Edgard Quintella; Costantino R Costantini; Adrian P M Korman; Marco A Mattos; Hélio J Castello; Adriano Caixeta; Hans F R Dohmann; Antonio C C de Carvalho Journal: Clin Cardiol Date: 2018-03-22 Impact factor: 2.882
Authors: Dan Yang; Connor Galen O'Brien; Gentaro Ikeda; Jay H Traverse; Doris A Taylor; Timothy D Henry; Roberto Bolli; Phillip C Yang Journal: Am Heart J Date: 2019-11-11 Impact factor: 4.749