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

Myocardial Infarction Clinical Trial

— AGTP II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02798276
• Other study ID #: ICOR-2016-01
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: April 2024

Study information

• Verified date: February 2024
• Source: Germans Trias i Pujol Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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).

Other:
• 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).

Locations

Country	Name	City	State
Portugal	Hospital São João, Faculty of Medicine, University of Porto	Porto
Spain	Complexo Hospitalario Universitario A Coruña	A Coruña
Spain	Germans Trias University Hospital; Germans Trias Research Institute	Badalona	Barcelona
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital Virgen de la Victoria	Málaga
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Son Espases Hospital	Palma De Mallorca
Spain	Hospital Universitario Nuestra Señora de Candelaria	Santa Cruz de Tenerife	Tenerife
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Clínico Universitario de Valladolid	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Antoni Bayés Genís

Countries where clinical trial is conducted

Portugal,  Spain, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in infarct size: left ventricular necrotic mass	grams	0-3-12 months
Primary	Changes in necrotic mass ratio (%) by gadolinium retention.	necrotic mass ratio (%)	0-3-12 months
Secondary	Improvement in regional contractibility by NMR	regional contractibility	0-3-12 months
Secondary	Changes in functional parameters by Nuclear Magnetic Resonance: ventricular ejection fraction	Left Ventricular Ejection Fraction, Right Ventricular Ejection Fraction (%)	0-3-12 months
Secondary	Changes in functional parameters by Nuclear Magnetic Resonance: ventricular volumes	LVESV, LVEDV, RVESV, RVEDV (mL)	0-3-12 months
Secondary	Changes in functional parameters by NMR: Cardiac output	L/min	0-3-12 months
Secondary	Levels of natriuretic peptides	NTproBNP	0-1 week-3-12 months
Secondary	Arrhythmia by 24-h Holter	Aupraventricular and ventricular arrhytmias	0--3-12 months
Secondary	All-cause death or re-admission	All-cause death or >24h re-hospitalization due to all-cause	12 months
Secondary	Cardiovascular death or re-admission	Cardiovascular death or >24h re-hospitalization due to cardiovascular causes	12 months