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Recruiting NCT02798276

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

◆ AI Clinical Summary

This trial tests a procedure called Adipose Graft Transposition (AGTP) that uses fat tissue from around the heart to help repair damage caused by a heart attack. Researchers believe this procedure may improve how well the heart pumps blood in patients who have had a previous heart attack.

Key Objective: The trial is testing whether transplanting healthy fat tissue can improve heart function and reduce damage in patients with permanent scarring from a previous heart attack.

Who to Consider: Patients with a history of heart attack who have chronic heart scarring and reduced heart function may want to consider enrolling in this trial.

Trial Parameters

Condition Myocardial Infarction
Sponsor Antoni Bayés Genís
Study Type INTERVENTIONAL
Phase N/A
Enrollment 70
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2017-03-01
Completion 2025-10
Interventions
AGTP-treatmentControl

Brief 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.

Eligibility Criteria

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

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