BACKGROUND: The increasing worldwide prevalence of coronary artery disease (CAD) continues to challenge the medical community. Management options include medical and revascularization therapy. Despite advances in these methods, CAD is a leading cause of recurrent ischemia and heart failure, posing significant morbidity and mortality risks along with increasing health costs in a large patient population worldwide. TRIAL DESIGN: The Cardiovascular Cell Therapy Research Network (CCTRN) was established by the National Institutes of Health to investigate the role of cell therapy in the treatment of chronic cardiovascular disease. FOCUS is a CCTRN-designed randomized, phase II, placebo-controlled clinical trial that will assess the effect of autologous bone marrow mononuclear cells delivered transendocardially to patients with left ventricular (LV) dysfunction and symptomatic heart failure or angina. All patients need to have limiting ischemia by reversible ischemia on single-photon emission computed tomography assessment. RESULTS: After thoughtful consideration of both statistical and clinical principles, we will recruit 87 patients (58 cell treated and 29placebo) to receive either bone marrow-derived stem cells or placebo. Myocardial perfusion, LV contractile performance, and maximal oxygen consumption are the primary outcome measures. CONCLUSIONS: The designed clinical trial will provide a sound assessment of the effect of autologous bone marrow mononuclear cells in improving blood flow and contractile function of the heart. The target population is patients with CAD and LV dysfunction with limiting angina or symptomatic heat failure. Patient safety is a central concern of the CCTRN, and patients will be followed for at least 5 years. Copyright 2010 Mosby, Inc. All rights reserved.
RCT Entities:
BACKGROUND: The increasing worldwide prevalence of coronary artery disease (CAD) continues to challenge the medical community. Management options include medical and revascularization therapy. Despite advances in these methods, CAD is a leading cause of recurrent ischemia and heart failure, posing significant morbidity and mortality risks along with increasing health costs in a large patient population worldwide. TRIAL DESIGN: The Cardiovascular Cell Therapy Research Network (CCTRN) was established by the National Institutes of Health to investigate the role of cell therapy in the treatment of chronic cardiovascular disease. FOCUS is a CCTRN-designed randomized, phase II, placebo-controlled clinical trial that will assess the effect of autologous bone marrow mononuclear cells delivered transendocardially to patients with left ventricular (LV) dysfunction and symptomatic heart failure or angina. All patients need to have limiting ischemia by reversible ischemia on single-photon emission computed tomography assessment. RESULTS: After thoughtful consideration of both statistical and clinical principles, we will recruit 87 patients (58 cell treated and 29 placebo) to receive either bone marrow-derived stem cells or placebo. Myocardial perfusion, LV contractile performance, and maximal oxygen consumption are the primary outcome measures. CONCLUSIONS: The designed clinical trial will provide a sound assessment of the effect of autologous bone marrow mononuclear cells in improving blood flow and contractile function of the heart. The target population is patients with CAD and LV dysfunction with limiting angina or symptomatic heat failure. Patient safety is a central concern of the CCTRN, and patients will be followed for at least 5 years. Copyright 2010 Mosby, Inc. All rights reserved.
Authors: Gerd P Meyer; Kai C Wollert; Joachim Lotz; Jan Steffens; Peter Lippolt; Stephanie Fichtner; Hartmut Hecker; Arnd Schaefer; Lubomir Arseniev; Bernd Hertenstein; Arnold Ganser; Helmut Drexler Journal: Circulation Date: 2006-03-06 Impact factor: 29.690
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Authors: Clyde W Yancy; Margarita Lopatin; Lynne Warner Stevenson; Teresa De Marco; Gregg C Fonarow Journal: J Am Coll Cardiol Date: 2005-12-15 Impact factor: 24.094
Authors: Francesca Bursi; Susan A Weston; Margaret M Redfield; Steven J Jacobsen; Serguei Pakhomov; Vuyisile T Nkomo; Ryan A Meverden; Véronique L Roger Journal: JAMA Date: 2006-11-08 Impact factor: 56.272
Authors: Earl S Ford; Umed A Ajani; Janet B Croft; Julia A Critchley; Darwin R Labarthe; Thomas E Kottke; Wayne H Giles; Simon Capewell Journal: N Engl J Med Date: 2007-06-07 Impact factor: 91.245
Authors: Martin Rodriguez-Porcel; Marvin W Kronenberg; Timothy D Henry; Jay H Traverse; Carl J Pepine; Stephen G Ellis; James T Willerson; Lemuel A Moyé; Robert D Simari Journal: JACC Cardiovasc Imaging Date: 2012-05
Authors: Emerson C Perin; James T Willerson; Carl J Pepine; Timothy D Henry; Stephen G Ellis; David X M Zhao; Guilherme V Silva; Dejian Lai; James D Thomas; Marvin W Kronenberg; A Daniel Martin; R David Anderson; Jay H Traverse; Marc S Penn; Saif Anwaruddin; Antonis K Hatzopoulos; Adrian P Gee; Doris A Taylor; Christopher R Cogle; Deirdre Smith; Lynette Westbrook; James Chen; Eileen Handberg; Rachel E Olson; Carrie Geither; Sherry Bowman; Judy Francescon; Sarah Baraniuk; Linda B Piller; Lara M Simpson; Catalin Loghin; David Aguilar; Sara Richman; Claudia Zierold; Judy Bettencourt; Shelly L Sayre; Rachel W Vojvodic; Sonia I Skarlatos; David J Gordon; Ray F Ebert; Minjung Kwak; Lemuel A Moyé; Robert D Simari Journal: JAMA Date: 2012-03-24 Impact factor: 56.272
Authors: Claudia Zierold; Marjorie A Carlson; Udo C Obodo; Elizabeth Wise; Victor A Piazza; Marshall W Meeks; Rachel W Vojvodic; Sarah Baraniuk; Timothy D Henry; Adrian P Gee; Stephen G Ellis; Lemuel A Moyé; Carl J Pepine; Christopher R Cogle; Doris A Taylor Journal: Am Heart J Date: 2011-12 Impact factor: 4.749
Authors: Jason M Duran; Sharven Taghavi; Remus M Berretta; Catherine A Makarewich; Thomas Sharp Iii; Tim Starosta; Foram Udeshi; Jon C George; Hajime Kubo; Steven R Houser Journal: Clin Transl Sci Date: 2012-06-26 Impact factor: 4.689
Authors: Doris A Taylor; Emerson C Perin; James T Willerson; Claudia Zierold; Micheline Resende; Marjorie Carlson; Belinda Nestor; Elizabeth Wise; Aaron Orozco; Carl J Pepine; Timothy D Henry; Stephen G Ellis; David X M Zhao; Jay H Traverse; John P Cooke; Robert C Schutt; Aruni Bhatnagar; Maria B Grant; Dejian Lai; Brian H Johnstone; Shelly L Sayre; Lem Moyé; Ray F Ebert; Roberto Bolli; Robert D Simari; Christopher R Cogle Journal: Cell Transplant Date: 2015-11-19 Impact factor: 4.064