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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - \> 18 years of age, capable of giving willing to sign a consent form. - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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 (9)

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