RT Journal Article
T1 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.
A1 Gastelurrutia, Paloma
A1 Gálvez-Montón, Carolina
A1 Cámara, Maria Luisa
A1 Bustamante-Munguira, Juan
A1 García-Pavia, Pablo
A1 Avanzas, Pablo
A1 Alberto San Román, J
A1 Pascual-Figal, Domingo
A1 Teresa, Eduardo de
A1 Crespo-Leiro, Maria G
A1 Manito, Nicolás
A1 Núñez, Julio
A1 Fernández-Avilés, Francisco
A1 Caballero, Ángel
A1 Teis, Albert
A1 Lupón, Josep
A1 Brugada, Ramón
A1 Martín, Carlos
A1 Silva, Jacobo
A1 Revilla-Orodea, Ana
A1 Cánovas, Sergio J
A1 Melero, Jose M
A1 Cuenca-Castillo, Jose J
A1 Gonzalez-Pinto, Angel
A1 Bayes-Genis, Antoni
K1 adipose progenitor cells
K1 cardiac regeneration
K1 chronic myocardial infarction
K1 clinical trials
K1 pericardial adipose graft
K1 tissue engineering
AB 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.
YR 2017
FD 2017-08-04
LK http://hdl.handle.net/10668/11478
UL http://hdl.handle.net/10668/11478
LA en
DS RISalud
RD Apr 7, 2025