Clinical trial NCT02798276: Efficacy of the Adipose Graft Transposition Procedure (AGTP) in Patients With a Myocardial Scar: The AGTP II Trial
Official title: Efficacy of the Adipose Graft Transposition Procedure (AGTP) in Patients With a Myocardial Scar: The AGTP II Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Keywords: Myocardial infarction
Cardiac regeneration
Cardiac surgery
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate the efficacy of a pericardial adipose graft transposition (Adipose Graft Trasposition Procedure, AGTP) for the improvement of cardiac function in patients with a chronic myocardial infarction. Preclinical studies in the porcine model of myocardial infarction have shown that the AGTP reduces infarct area and improves cardiac function. A first-in-man clinical (NCT01473433) trial showed that the AGTP is safe in patients.


Eligibility criteria: Inclusion Criteria:

* \> 18 years of age, capable of giving informed consent.
* Q wave in the ECG
* Myocardial infarct \>=50% transmularity by NMR non revascularizable (for transmurality or bad vessel).
* Candidate to bypass for other myocardial areas

Exclusion Criteria:

* Severe non cardiac co-morbidity with a reduction of life expectancy of less than 1 year
* Severe valvular disease candidate for surgical restoration
* Candidate to ventricular remodeling
* Contraindication for NMR
* Severe renal or hepatic failure
* Abnoraml laboratory tests (no explanation at inclusion)
* Previous cardiac intervention
* Pregnant or breast feeding women

Primary outcomes:
measure: Changes in necrotic mass ratio (%) by gadolinium retention.
timeFrame: 0-3-12 months
Secondary outcomes:
measure: Improvement in regional contractibility by NMR
timeFrame: 0-3-12 months
measure: Changes in functional parameters by Nuclear Magnetic Resonance: ventricular ejection fraction
timeFrame: 0-3-12 months
measure: Changes in functional parameters by Nuclear Magnetic Resonance: ventricular volumes
timeFrame: 0-3-12 months
measure: Changes in functional parameters by NMR: Cardiac output
timeFrame: 0-3-12 months
measure: Levels of natriuretic peptides
timeFrame: 0-1 week-3-12 months
measure: Arrhythmia by 24-h Holter
timeFrame: 0--3-12 months
measure: All-cause death or re-admission
timeFrame: 12 months
measure: Cardiovascular death or re-admission
timeFrame: 12 months
Other outcomes:
measure: Changes in infarct size: left ventricular necrotic mass
timeFrame: 0-3-12 months
Locations:
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Badalona
country: Spain
facility: Germans Trias University Hospital; Germans Trias Research Institute
state: Barcelona
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
city: Málaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Palma De Mallorca
country: Spain
facility: Son Espases Hospital
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
Study officials:
References:
citation: Bayes-Genis A, Galvez-Monton C, Prat-Vidal C, Soler-Botija C. Cardiac adipose tissue: a new frontier for cardiac regeneration? Int J Cardiol. 2013 Jul 15;167(1):22-5. doi: 10.1016/j.ijcard.2012.05.082. Epub 2012 Jun 17.
citation: Galvez-Monton C, Prat-Vidal C, Roura S, Soler-Botija C, Llucia-Valldeperas A, Diaz-Guemes I, Sanchez-Margallo FM, Bayes-Genis A. Post-infarction scar coverage using a pericardial-derived vascular adipose flap. Pre-clinical results. Int J Cardiol. 2013 Jun 20;166(2):469-74. doi: 10.1016/j.ijcard.2011.11.019. Epub 2011 Dec 2.
citation: Galvez-Monton C, Prat-Vidal C, Roura S, Farre J, Soler-Botija C, Llucia-Valldeperas A, Diaz-Guemes I, Sanchez-Margallo FM, Aris A, Bayes-Genis A. Transposition of a pericardial-derived vascular adipose flap for myocardial salvage after infarct. Cardiovasc Res. 2011 Sep 1;91(4):659-67. doi: 10.1093/cvr/cvr136. Epub 2011 May 16.
citation: Bayes-Genis A, Gastelurrutia P, Camara ML, Teis A, Lupon J, Llibre C, Zamora E, Alomar X, Ruyra X, Roura S, Revilla A, San Roman JA, Galvez-Monton C. First-in-man Safety and Efficacy of the Adipose Graft Transposition Procedure (AGTP) in Patients With a Myocardial Scar. EBioMedicine. 2016 May;7:248-54. doi: 10.1016/j.ebiom.2016.03.027. Epub 2016 Apr 10.
citation: Ma H, Liu J, Qian L. Fat for fostering: Regenerating injured heart using local adipose tissue. EBioMedicine. 2016 May;7:25-6. doi: 10.1016/j.ebiom.2016.03.024. Epub 2016 Mar 20. No abstract available.
citation: Gastelurrutia P, Galvez-Monton C, Camara ML, Bustamante-Munguira J, Garcia-Pavia P, Avanzas P, Alberto San Roman J, Pascual-Figal D, Teresa E, Crespo-Leiro MG, Manito N, Nunez J, Fernandez-Aviles F, Caballero A, Teis A, Lupon J, Brugada R, Martin C, Silva J, Revilla-Orodea A, Canovas SJ, Melero JM, Cuenca-Castillo JJ, Gonzalez-Pinto A, Bayes-Genis A. 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. BMJ Open. 2017 Aug 4;7(8):e017187. doi: 10.1136/bmjopen-2017-017187.