Efficacy of the Adipose Graft Transposition Procedure (AGTP) in Patients With a Myocardial Scar: The AGTP II Trial

NCT02798276 | Recruiting

• 1 other identifier: ICOR-2016-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 9

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.

Conditions

Myocardial Infarction

Keywords

Myocardial infarction; Cardiac regeneration; Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Changes in necrotic mass ratio (%) by gadolinium retention.

  necrotic mass ratio (%)

  0-3-12 months

Secondary Outcomes (8)

• Improvement in regional contractibility by NMR

  0-3-12 months

• Changes in functional parameters by Nuclear Magnetic Resonance: ventricular ejection fraction

  0-3-12 months

• Changes in functional parameters by Nuclear Magnetic Resonance: ventricular volumes

  0-3-12 months

• Changes in functional parameters by NMR: Cardiac output

  0-3-12 months

• Levels of natriuretic peptides

  0-1 week-3-12 months

Other Outcomes (1)

• Changes in infarct size: left ventricular necrotic mass

  0-3-12 months

Study Arms (2)

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.

Procedure: AGTP-treatment

Control

OTHER

Patients in with the non-revascularizable area will be left untouched and the revascularizable area will be treated normally.

Other: Control

Interventions

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).

AGTP-treatment

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).

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• 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
• Previous cardiac intervention
• Pregnant or breast feeding women

Sponsors & Collaborators

• Antoni Bayés Genís: lead

Study Sites (9)

Germans Trias University Hospital; Germans Trias Research Institute

Badalona, Barcelona, 08916, Spain

RECRUITING

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

RECRUITING

Hospital Virgen de la Victoria

Málaga, 29010, Spain

NOT YET RECRUITING

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

NOT YET RECRUITING

Son Espases Hospital

Palma de Mallorca, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

RECRUITING

Hospital Clínico Universitario de Valladolid

Valladolid, 47003, Spain

RECRUITING

Related Publications (6)

• 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.

  PMID: 22709728 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.

  PMID: 22137092 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.

  PMID: 21576133 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.

  PMID: 27322478 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.

  PMID: 27322455 BACKGROUND

• 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.

  PMID: 28780562 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Antoni Bayes-Genis, Chief of the Cardiology Service

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 14, 2016
• Study Start: March 1, 2017
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

ES (9)