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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGTP-treatment | Experimental | Patients in which the non-revascularizable area will be covered by the adipose graft and the revascularizable area will be treated with the normal procedure. |
|
| Control | Other | Patients in with the non-revascularizable area will be left untouched and the revascularizable area will be treated normally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGTP-treatment | Procedure | Patients with a myocardial necrosis candidates for revascularization of other myocardial areas, will be enrolled. The non-revascularizable area will be covered with the adipose graft and the revascularizable area will be treated with the normal procedure (by-pass). |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in necrotic mass ratio (%) by gadolinium retention. | necrotic mass ratio (%) | 0-3-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in regional contractibility by NMR | regional contractibility | 0-3-12 months |
| Changes in functional parameters by Nuclear Magnetic Resonance: ventricular ejection fraction | Left Ventricular Ejection Fraction, Right Ventricular Ejection Fraction (%) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in infarct size: left ventricular necrotic mass | grams | 0-3-12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Germans Trias University Hospital; Germans Trias Research Institute | Recruiting | Badalona | Barcelona | 08916 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22709728 | Background | 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. | |
| 22137092 | Background | 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. |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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|
| Control | Other | Patients with a myocardial necrosis, candidates for revascularization of other myocardial areas, will be enrolled. The non-revascularizable area will be left untouched and the revascularizable area will be treated normally (by-pass). |
|
| 0-3-12 months |
| Changes in functional parameters by Nuclear Magnetic Resonance: ventricular volumes | LVESV, LVEDV, RVESV, RVEDV (mL) | 0-3-12 months |
| Changes in functional parameters by NMR: Cardiac output | L/min | 0-3-12 months |
| Levels of natriuretic peptides | NTproBNP | 0-1 week-3-12 months |
| Arrhythmia by 24-h Holter | Aupraventricular and ventricular arrhytmias | 0--3-12 months |
| All-cause death or re-admission | All-cause death or >24h re-hospitalization due to all-cause | 12 months |
| Cardiovascular death or re-admission | Cardiovascular death or >24h re-hospitalization due to cardiovascular causes | 12 months |
| Hospital Universitario Puerta de Hierro | Recruiting | Majadahonda | Madrid | 28222 | Spain |
|
| Hospital Universitario Central de Asturias | Recruiting | Oviedo | Principality of Asturias | 33011 | Spain |
|
| Hospital General Universitario Gregorio Marañón | Recruiting | Madrid | 28007 | Spain |
|
| Hospital Virgen de la Victoria | Not yet recruiting | Málaga | 29010 | Spain |
|
| Hospital Clínico Universitario Virgen de la Arrixaca | Not yet recruiting | Murcia | 30120 | Spain |
|
| Son Espases Hospital | Recruiting | Palma de Mallorca | Spain |
|
| Hospital Clínico Universitario de Valencia | Recruiting | Valencia | 46010 | Spain |
|
| Hospital Clínico Universitario de Valladolid | Recruiting | Valladolid | 47003 | Spain |
|
| 21576133 | Background | 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. |
| 27322478 | Background | 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. |
| 27322455 | Background | 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. |
| 28780562 | Derived | 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. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |