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

Antoni Bayés Genís

Status: Enrolling

Conditions: Myocardial Infarction

Treatments: Procedure: AGTP-treatment; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02798276

ICOR-2016-01

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

AGTP-treatment

Experimental group

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.

Treatment:

Procedure: AGTP-treatment

Control

Other group

Description:

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

Treatment:

Other: Control