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

Antoni Bayés Genís71 enrolled

Overview

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

Conditions

Myocardial Infarction

Interventions

AGTP-treatmentPROCEDURE

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).

ControlOTHER

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

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

necrotic mass ratio (%)

Time frame: 0-3-12 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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