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

Paloma Gastelurrutia, Carolina Gálvez-Montón, Maria Luisa Cámara, Juan Bustamante-Munguira, Pablo García-Pavia, Pablo Avanzas, J. Alberto San Román, Domingo Pascual-Figal, Eduardo De Teresa, Maria G. Crespo-Leiro, Nicolás Manito, Julio Núñez, Francisco Fernández-Avilés, Ángel Caballero, Albert Teis, Josep Lupón, Ramón Brugada, Carlos Martín, Jacobo Silva, Ana Revilla-OrodeaSergio J. Cánovas, Jose M. Melero, Jose J. Cuenca-Castillo, Angel Gonzalez-Pinto, Antoni Bayes-Genis

Research output: Contribution to journalArticleResearchpeer-review

4 Citations (Scopus)

Abstract

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. 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.
Original languageEnglish
Article numbere017187
JournalBMJ Open
Volume7
Issue number8
DOIs
Publication statusPublished - 1 Aug 2017

Keywords

  • adipose progenitor cells
  • cardiac regeneration
  • chronic myocardial infarction
  • clinical trials
  • pericardial adipose graft
  • tissue engineering

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