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 (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Gálvez-Montón, Carolina (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Cámara, Maria-Luisa (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Bustamante-Munguira, Juan (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
García-Pavía, Pablo (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Avanzas, Pablo (Hospital Universitario Central de Asturias)
Alberto San Román, J. (Hospital Clínico Universitario de Valladolid)
Pascual-Figal, Domingo (Hospital Clínico Universitario Virgen de la Arrixaca (El Palmar, Múrcia))
De Teresa, Eduardo (Hospital Universitario Virgen de la Victoria (Màlaga, Andalusia))
Crespo-Leiro, Maria Generosa (Complejo Hospitalario Universitario de A Coruña)
Manito, Nicolás (Hospital Universitari de Bellvitge)
Núñez, Julio (Hospital Clínic Universitari (València))
Fernández Avilés, F (Hospital General Universitario Gregorio Marañón. Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM))
Caballero, Ángel (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Teis, Albert (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Lupón, Josep (Universitat Autònoma de Barcelona. Departament de Medicina)
Brugada, Ramon (Hospital Universitari de Girona Doctor Josep Trueta)
Martín, Carlos (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Silva, Jacobo (Hospital Universitario Central de Asturias)
Revilla-Orodea, Ana (Hospital Clínico Universitario de Valladolid)
Cánovas López, Sergio Juan (Hospital Clínico Universitario Virgen de la Arrixaca (El Palmar, Múrcia))
Melero, Jose M. (Hospital Universitario Virgen de la Victoria (Màlaga, Andalusia))
Cuenca-Castillo, Jose J. (Complejo Hospitalario Universitario de A Coruña)
Gonzalez-Pinto, Angel (Hospital General Universitario Gregorio Marañón. Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM))
Bayés-Genís, Antoni (Universitat Autònoma de Barcelona. Departament de Medicina)

Date:	2017
Abstract:	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. 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. 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. ClinicalTrials. gov: NCT02798276, pre-results.
Grants:	Ministerio de Economía y Competitividad SAF2014-59892-R Ministerio de Economía y Competitividad JCI-2012-14025
Note:	Altres ajuts: Fundació La Marató de TV3 (201502, 201516)
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Published in:	BMJ open, Vol. 7 (august 2017) , ISSN 2044-6055

DOI: 10.1136/bmjopen-2017-017187
PMID: 28780562

7 p, 1.6 MB

The record appears in these collections:
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Articles > Research articles
Articles > Published articles