1. 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
- Author
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Pablo Avanzas, J. Alberto San Román, Ramon Brugada, Eduardo de Teresa, Jacobo Silva, Domingo A. Pascual-Figal, Pablo García-Pavia, Julio Núñez, María G. Crespo-Leiro, Josep Lupón, Ana Revilla-Orodea, Maria Luisa Camara, Francisco Fernández-Avilés, Ángel González-Pinto, José J. Cuenca-Castillo, Ángel Caballero, Nicolás Manito, Juan Bustamante-Munguira, Carolina Gálvez-Montón, Sergio Cánovas, Albert Teis, Antoni Bayes-Genis, José M. Melero, Paloma Gastelurrutia, and Carlos Martín
- Subjects
0301 basic medicine ,Cardiac function curve ,Adult ,Male ,medicine.medical_specialty ,Cardiac Volume ,Myocardial Infarction ,Adipose tissue ,030204 cardiovascular system & hematology ,Cardiovascular Medicine ,Transplantation, Autologous ,Ventricular Function, Left ,03 medical and health sciences ,Cicatrix ,0302 clinical medicine ,pericardial adipose graft ,Natriuretic Peptide, Brain ,Clinical endpoint ,Protocol ,Medicine ,Humans ,Regeneration ,Myocardial infarction ,Prospective Studies ,Coronary Artery Bypass ,adipose progenitor cells ,Randomized Controlled Trials as Topic ,clinical trials ,Ejection fraction ,business.industry ,Myocardium ,cardiac regeneration ,General Medicine ,Brain natriuretic peptide ,Institutional review board ,medicine.disease ,Peptide Fragments ,Surgery ,Clinical trial ,030104 developmental biology ,Treatment Outcome ,Adipose Tissue ,Research Design ,tissue engineering ,chronic myocardial infarction ,Female ,business - Abstract
IntroductionCardiac 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 designThe 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 disseminationThe 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 numberClinicalTrials.gov:NCT02798276, pre-results.
- Published
- 2017