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

Primary Purpose

Myocardial Infarction

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
AGTP-treatment
Control
Sponsored by
Antoni Bayés Genís
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Myocardial infarction, Cardiac regeneration, Cardiac surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital São João, Faculty of Medicine, University of PortoRecruiting
  • Hospital Universitario Central de Asturias
  • Germans Trias University Hospital; Germans Trias Research InstituteRecruiting
  • Hospital Universitario Puerta de Hierro
  • Hospital Universitario Nuestra Señora de Candelaria
  • Complexo Hospitalario Universitario A Coruña
  • Hospital General Universitario Gregorio Marañón
  • Hospital Clínico Universitario Virgen de la Arrixaca
  • Hospital Virgen de la Victoria
  • Son Espases Hospital
  • Hospital Clínico Universitario de Valencia
  • Hospital Clínico Universitario de ValladolidRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

AGTP-treatment

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Improvement in regional contractibility by NMR
regional contractibility
Changes in functional parameters by Nuclear Magnetic Resonance: ventricular ejection fraction
Left Ventricular Ejection Fraction, Right Ventricular Ejection Fraction (%)
Changes in functional parameters by Nuclear Magnetic Resonance: ventricular volumes
LVESV, LVEDV, RVESV, RVEDV (mL)
Changes in functional parameters by NMR: Cardiac output
L/min
Levels of natriuretic peptides
NTproBNP
Arrhythmia by 24-h Holter
Aupraventricular and ventricular arrhytmias
All-cause death or re-admission
All-cause death or >24h re-hospitalization due to all-cause
Cardiovascular death or re-admission
Cardiovascular death or >24h re-hospitalization due to cardiovascular causes

Full Information

First Posted
May 26, 2016
Last Updated
October 6, 2023
Sponsor
Antoni Bayés Genís
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1. Study Identification

Unique Protocol Identification Number
NCT02798276
Brief Title
Efficacy of the Adipose Graft Transposition Procedure (AGTP) in Patients With a Myocardial Scar: The AGTP II Trial
Acronym
AGTP II
Official Title
Efficacy of the Adipose Graft Transposition Procedure (AGTP) in Patients With a Myocardial Scar: The AGTP II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Antoni Bayés Genís

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Myocardial infarction, Cardiac regeneration, Cardiac surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AGTP-treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
Patients in with the non-revascularizable area will be left untouched and the revascularizable area will be treated normally.
Intervention Type
Procedure
Intervention Name(s)
AGTP-treatment
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
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).
Primary Outcome Measure Information:
Title
Changes in necrotic mass ratio (%) by gadolinium retention.
Description
necrotic mass ratio (%)
Time Frame
0-3-12 months
Secondary Outcome Measure Information:
Title
Improvement in regional contractibility by NMR
Description
regional contractibility
Time Frame
0-3-12 months
Title
Changes in functional parameters by Nuclear Magnetic Resonance: ventricular ejection fraction
Description
Left Ventricular Ejection Fraction, Right Ventricular Ejection Fraction (%)
Time Frame
0-3-12 months
Title
Changes in functional parameters by Nuclear Magnetic Resonance: ventricular volumes
Description
LVESV, LVEDV, RVESV, RVEDV (mL)
Time Frame
0-3-12 months
Title
Changes in functional parameters by NMR: Cardiac output
Description
L/min
Time Frame
0-3-12 months
Title
Levels of natriuretic peptides
Description
NTproBNP
Time Frame
0-1 week-3-12 months
Title
Arrhythmia by 24-h Holter
Description
Aupraventricular and ventricular arrhytmias
Time Frame
0--3-12 months
Title
All-cause death or re-admission
Description
All-cause death or >24h re-hospitalization due to all-cause
Time Frame
12 months
Title
Cardiovascular death or re-admission
Description
Cardiovascular death or >24h re-hospitalization due to cardiovascular causes
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Changes in infarct size: left ventricular necrotic mass
Description
grams
Time Frame
0-3-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hospital São João, Faculty of Medicine, University of Porto
City
Porto
ZIP/Postal Code
4099-002
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisca Saraiva
Phone
+351 220426829
Email
franciscasaraiva13@gmail.com
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo Avanzas
Phone
0034 985108000
First Name & Middle Initial & Last Name & Degree
Pablo Avanzas, PhD
Facility Name
Germans Trias University Hospital; Germans Trias Research Institute
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paloma Gastelurrutia
Phone
0034 934978670
Email
pgastelurrutia@gmail.com
First Name & Middle Initial & Last Name & Degree
Pol Gomez
Phone
0034 934978662
Email
grupicrec@gmail.com
First Name & Middle Initial & Last Name & Degree
Antoni Bayes-Genis, PhD
First Name & Middle Initial & Last Name & Degree
Paloma Gastelurrutia, PhD
First Name & Middle Initial & Last Name & Degree
Josep Lupon, PhD
First Name & Middle Initial & Last Name & Degree
Maria Luisa Cámara, PhD
Facility Name
Hospital Universitario Puerta de Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo García Pavía
Phone
0034 911916000
First Name & Middle Initial & Last Name & Degree
Pablo García Pavía, PhD
Facility Name
Hospital Universitario Nuestra Señora de Candelaria
City
Santa Cruz de Tenerife
State/Province
Tenerife
ZIP/Postal Code
38010
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julio Hernández
Phone
0034 922602000
First Name & Middle Initial & Last Name & Degree
Julio Hernández Afonso, PhD
First Name & Middle Initial & Last Name & Degree
Rafael Llorens
Facility Name
Complexo Hospitalario Universitario A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zulaika Grille
Phone
0034 981178000
First Name & Middle Initial & Last Name & Degree
María G Crespo Leiro, PhD
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastián Consulta de Investigación Cardiología
Phone
0034 915868000
First Name & Middle Initial & Last Name & Degree
Francisco Fernández Avilés, PhD
Facility Name
Hospital Clínico Universitario Virgen de la Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Teresa Pérez Martínez
Phone
0034 968369500
First Name & Middle Initial & Last Name & Degree
Domingo Pascual Figal, PhD
Facility Name
Hospital Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Jiménez Navarro
Phone
0034 951032000
First Name & Middle Initial & Last Name & Degree
Eduardo de Teresa, PhD
Facility Name
Son Espases Hospital
City
Palma De Mallorca
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Padrol Bages
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julio Núñez
Phone
0034 961973500
First Name & Middle Initial & Last Name & Degree
Julio Núñez, PhD
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis H Varela Falcón
Phone
0034 983420000
Email
lhvf86@hotmail.com
First Name & Middle Initial & Last Name & Degree
Alberto San Román

12. IPD Sharing Statement

Citations:
PubMed Identifier
22709728
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.
Results Reference
background
PubMed Identifier
22137092
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.
Results Reference
background
PubMed Identifier
21576133
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.
Results Reference
background
PubMed Identifier
27322478
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.
Results Reference
background
PubMed Identifier
27322455
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.
Results Reference
background
PubMed Identifier
28780562
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.
Results Reference
derived

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

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