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Rationale and design of a multicentre, prospective, randomised, controlled clinical trial to evaluate the efficacy of the adipose graft transposition procedure in patients with a myocardial scar: the AGTP II trial

INTRODUCTION: Cardiac adipose tissue is a source of progenitor cells with regenerative capacity. Studies in rodents demonstrated that the intramyocardial delivery of cells derived from this tissue improves cardiac function after myocardial infarction (MI). We developed a new reparative approach for...

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Autores principales: Gastelurrutia, Paloma, Gálvez-Montón, Carolina, Cámara, Maria Luisa, Bustamante-Munguira, Juan, García-Pavia, Pablo, Avanzas, Pablo, Alberto San Román, J, Pascual-Figal, Domingo, de Teresa, Eduardo, Crespo-Leiro, Maria G, Manito, Nicolás, Núñez, Julio, Fernández-Avilés, Francisco, Caballero, Ángel, Teis, Albert, Lupón, Josep, Brugada, Ramón, Martín, Carlos, Silva, Jacobo, Revilla-Orodea, Ana, Cánovas, Sergio J, Melero, Jose M, Cuenca-Castillo, Jose J, Gonzalez-Pinto, Angel, Bayes-Genis, Antoni
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5724153/
https://www.ncbi.nlm.nih.gov/pubmed/28780562
http://dx.doi.org/10.1136/bmjopen-2017-017187
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author Gastelurrutia, Paloma
Gálvez-Montón, Carolina
Cámara, Maria Luisa
Bustamante-Munguira, Juan
García-Pavia, Pablo
Avanzas, Pablo
Alberto San Román, J
Pascual-Figal, Domingo
de Teresa, Eduardo
Crespo-Leiro, Maria G
Manito, Nicolás
Núñez, Julio
Fernández-Avilés, Francisco
Caballero, Ángel
Teis, Albert
Lupón, Josep
Brugada, Ramón
Martín, Carlos
Silva, Jacobo
Revilla-Orodea, Ana
Cánovas, Sergio J
Melero, Jose M
Cuenca-Castillo, Jose J
Gonzalez-Pinto, Angel
Bayes-Genis, Antoni
author_facet Gastelurrutia, Paloma
Gálvez-Montón, Carolina
Cámara, Maria Luisa
Bustamante-Munguira, Juan
García-Pavia, Pablo
Avanzas, Pablo
Alberto San Román, J
Pascual-Figal, Domingo
de Teresa, Eduardo
Crespo-Leiro, Maria G
Manito, Nicolás
Núñez, Julio
Fernández-Avilés, Francisco
Caballero, Ángel
Teis, Albert
Lupón, Josep
Brugada, Ramón
Martín, Carlos
Silva, Jacobo
Revilla-Orodea, Ana
Cánovas, Sergio J
Melero, Jose M
Cuenca-Castillo, Jose J
Gonzalez-Pinto, Angel
Bayes-Genis, Antoni
author_sort Gastelurrutia, Paloma
collection PubMed
description INTRODUCTION: Cardiac adipose tissue is a source of progenitor cells with regenerative capacity. Studies in rodents demonstrated that the intramyocardial delivery of cells derived from this tissue improves cardiac function after myocardial infarction (MI). We developed a new reparative approach for damaged myocardium that integrates the regenerative properties of cardiac adipose tissue with tissue engineering. In the adipose graft transposition procedure (AGTP), we dissect a vascularised flap of autologous pericardial adipose tissue and position it over the myocardial scarred area. Following encouraging results in acute and chronic MI porcine models, we performed the clinical trial (NCT01473433, AdiFLAP trial) to evaluate safety in patients with chronic MI undergoing coronary artery bypass graft. The good safety profile and trends in efficacy warranted a larger trial. STUDY DESIGN: The AGTP II trial (NCT02798276) is an investigator initiated, prospective, randomised, controlled, multicentre study to assess the efficacy of the AGTP in 108 patients with non-revascularisable MI. Patients will be assigned to standard clinical practice or the AGTP. The primary endpoint is change in necrotic mass ratio by gadolinium enhancement at 91 and 365 days. Secondary endpoints include improvement in regional contractibility by MRI at 91 and 365 days; changes in functional MRI parameters (left ventricular ejection fraction, left and right ventricular geometric remodelling) at 91 and 365 days; levels of N-terminal prohormone of brain natriuretic peptide (NT-proBNP) at 7, 91 and 365 days; appearance of arrhythmias from 24 hour Holter monitoring at 24 hours, and at 91 and 365 days; all cause death or re-hospitalisation at 365 days; and cardiovascular death or re-hospitalisation at 365 days. ETHICS AND DISSEMINATION: The institutional review board approved the trial which will comply with the Declaration of Helsinki. All patients will provide informed consent. It may offer a novel, effective and technically simple technique for patients with no other therapeutic options. The results will be submitted to indexed medical journals and national and international meetings. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT02798276, pre-results.
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spelling pubmed-57241532017-12-19 Rationale and design of a multicentre, prospective, randomised, controlled clinical trial to evaluate the efficacy of the adipose graft transposition procedure in patients with a myocardial scar: the AGTP II trial Gastelurrutia, Paloma Gálvez-Montón, Carolina Cámara, Maria Luisa Bustamante-Munguira, Juan García-Pavia, Pablo Avanzas, Pablo Alberto San Román, J Pascual-Figal, Domingo de Teresa, Eduardo Crespo-Leiro, Maria G Manito, Nicolás Núñez, Julio Fernández-Avilés, Francisco Caballero, Ángel Teis, Albert Lupón, Josep Brugada, Ramón Martín, Carlos Silva, Jacobo Revilla-Orodea, Ana Cánovas, Sergio J Melero, Jose M Cuenca-Castillo, Jose J Gonzalez-Pinto, Angel Bayes-Genis, Antoni BMJ Open Cardiovascular Medicine INTRODUCTION: Cardiac adipose tissue is a source of progenitor cells with regenerative capacity. Studies in rodents demonstrated that the intramyocardial delivery of cells derived from this tissue improves cardiac function after myocardial infarction (MI). We developed a new reparative approach for damaged myocardium that integrates the regenerative properties of cardiac adipose tissue with tissue engineering. In the adipose graft transposition procedure (AGTP), we dissect a vascularised flap of autologous pericardial adipose tissue and position it over the myocardial scarred area. Following encouraging results in acute and chronic MI porcine models, we performed the clinical trial (NCT01473433, AdiFLAP trial) to evaluate safety in patients with chronic MI undergoing coronary artery bypass graft. The good safety profile and trends in efficacy warranted a larger trial. STUDY DESIGN: The AGTP II trial (NCT02798276) is an investigator initiated, prospective, randomised, controlled, multicentre study to assess the efficacy of the AGTP in 108 patients with non-revascularisable MI. Patients will be assigned to standard clinical practice or the AGTP. The primary endpoint is change in necrotic mass ratio by gadolinium enhancement at 91 and 365 days. Secondary endpoints include improvement in regional contractibility by MRI at 91 and 365 days; changes in functional MRI parameters (left ventricular ejection fraction, left and right ventricular geometric remodelling) at 91 and 365 days; levels of N-terminal prohormone of brain natriuretic peptide (NT-proBNP) at 7, 91 and 365 days; appearance of arrhythmias from 24 hour Holter monitoring at 24 hours, and at 91 and 365 days; all cause death or re-hospitalisation at 365 days; and cardiovascular death or re-hospitalisation at 365 days. ETHICS AND DISSEMINATION: The institutional review board approved the trial which will comply with the Declaration of Helsinki. All patients will provide informed consent. It may offer a novel, effective and technically simple technique for patients with no other therapeutic options. The results will be submitted to indexed medical journals and national and international meetings. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT02798276, pre-results. BMJ Publishing Group 2017-08-04 /pmc/articles/PMC5724153/ /pubmed/28780562 http://dx.doi.org/10.1136/bmjopen-2017-017187 Text en © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
spellingShingle Cardiovascular Medicine
Gastelurrutia, Paloma
Gálvez-Montón, Carolina
Cámara, Maria Luisa
Bustamante-Munguira, Juan
García-Pavia, Pablo
Avanzas, Pablo
Alberto San Román, J
Pascual-Figal, Domingo
de Teresa, Eduardo
Crespo-Leiro, Maria G
Manito, Nicolás
Núñez, Julio
Fernández-Avilés, Francisco
Caballero, Ángel
Teis, Albert
Lupón, Josep
Brugada, Ramón
Martín, Carlos
Silva, Jacobo
Revilla-Orodea, Ana
Cánovas, Sergio J
Melero, Jose M
Cuenca-Castillo, Jose J
Gonzalez-Pinto, Angel
Bayes-Genis, Antoni
Rationale and design of a multicentre, prospective, randomised, controlled clinical trial to evaluate the efficacy of the adipose graft transposition procedure in patients with a myocardial scar: the AGTP II trial
title Rationale and design of a multicentre, prospective, randomised, controlled clinical trial to evaluate the efficacy of the adipose graft transposition procedure in patients with a myocardial scar: the AGTP II trial
title_full Rationale and design of a multicentre, prospective, randomised, controlled clinical trial to evaluate the efficacy of the adipose graft transposition procedure in patients with a myocardial scar: the AGTP II trial
title_fullStr Rationale and design of a multicentre, prospective, randomised, controlled clinical trial to evaluate the efficacy of the adipose graft transposition procedure in patients with a myocardial scar: the AGTP II trial
title_full_unstemmed Rationale and design of a multicentre, prospective, randomised, controlled clinical trial to evaluate the efficacy of the adipose graft transposition procedure in patients with a myocardial scar: the AGTP II trial
title_short Rationale and design of a multicentre, prospective, randomised, controlled clinical trial to evaluate the efficacy of the adipose graft transposition procedure in patients with a myocardial scar: the AGTP II trial
title_sort rationale and design of a multicentre, prospective, randomised, controlled clinical trial to evaluate the efficacy of the adipose graft transposition procedure in patients with a myocardial scar: the agtp ii trial
topic Cardiovascular Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5724153/
https://www.ncbi.nlm.nih.gov/pubmed/28780562
http://dx.doi.org/10.1136/bmjopen-2017-017187
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