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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
70
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).
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).
Germans Trias University Hospital; Germans Trias Research Institute
Badalona, Barcelona, Spain
RECRUITINGHospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
RECRUITINGHospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
RECRUITINGHospital General Universitario Gregorio Marañón
Madrid, Spain
RECRUITINGHospital Virgen de la Victoria
Málaga, Spain
NOT_YET_RECRUITINGHospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain
NOT_YET_RECRUITINGSon Espases Hospital
Palma de Mallorca, Spain
RECRUITINGHospital Clínico Universitario de Valencia
Valencia, Spain
RECRUITINGHospital Clínico Universitario de Valladolid
Valladolid, Spain
RECRUITINGChanges in necrotic mass ratio (%) by gadolinium retention.
necrotic mass ratio (%)
Time frame: 0-3-12 months
Improvement in regional contractibility by NMR
regional contractibility
Time frame: 0-3-12 months
Changes in functional parameters by Nuclear Magnetic Resonance: ventricular ejection fraction
Left Ventricular Ejection Fraction, Right Ventricular Ejection Fraction (%)
Time frame: 0-3-12 months
Changes in functional parameters by Nuclear Magnetic Resonance: ventricular volumes
LVESV, LVEDV, RVESV, RVEDV (mL)
Time frame: 0-3-12 months
Changes in functional parameters by NMR: Cardiac output
L/min
Time frame: 0-3-12 months
Levels of natriuretic peptides
NTproBNP
Time frame: 0-1 week-3-12 months
Arrhythmia by 24-h Holter
Aupraventricular and ventricular arrhytmias
Time frame: 0--3-12 months
All-cause death or re-admission
All-cause death or \>24h re-hospitalization due to all-cause
Time frame: 12 months
Cardiovascular death or re-admission
Cardiovascular death or \>24h re-hospitalization due to cardiovascular causes
Time frame: 12 months
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