Efficacy of the Adipose Graft Transposition Procedure (AGTP) in Patients With a Myocardial Scar: The AGTP II Trial
NCT ID: NCT02798276
Last Updated: 2024-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2017-03-01
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AGTP-treatment
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.
AGTP-treatment
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).
Control
Patients in with the non-revascularizable area will be left untouched and the revascularizable area will be treated normally.
Control
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).
Interventions
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AGTP-treatment
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).
Control
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).
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Antoni Bayés Genís
OTHER
Responsible Party
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Antoni Bayés Genís
Antoni Bayes-Genis, Chief of the Cardiology Service
Locations
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Germans Trias University Hospital; Germans Trias Research Institute
Badalona, Barcelona, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Virgen de la Victoria
Málaga, , Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, , Spain
Son Espases Hospital
Palma de Mallorca, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hospital Clínico Universitario de Valladolid
Valladolid, , Spain
Countries
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Facility Contacts
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Sebastián Consulta de Investigación Cardiología
Role: primary
Manuel Jiménez Navarro
Role: primary
Maria Teresa Pérez Martínez
Role: primary
References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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ICOR-2016-01
Identifier Type: -
Identifier Source: org_study_id
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