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

Study Overview
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Brief Summary
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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.

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

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Procedure: AGTP-treatment
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGTP-treatment<br>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. | Procedure: AGTP-treatment<br>* 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).<br>|
| Other: Control<br>Patients in with the non-revascularizable area will be left untouched and the revascularizable area will be treated normally. | Other: Control<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in necrotic mass ratio (%) by gadolinium retention. | necrotic mass ratio (%) | 0-3-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in regional contractibility by NMR | regional contractibility | 0-3-12 months | 
| Changes in functional parameters by Nuclear Magnetic Resonance: ventricular ejection fraction | Left Ventricular Ejection Fraction, Right Ventricular Ejection Fraction (%) | 0-3-12 months | 
| Changes in functional parameters by Nuclear Magnetic Resonance: ventricular volumes | LVESV, LVEDV, RVESV, RVEDV (mL) | 0-3-12 months | 
| Changes in functional parameters by NMR: Cardiac output | L/min | 0-3-12 months | 
| Levels of natriuretic peptides | NTproBNP | 0-1 week-3-12 months | 
| Arrhythmia by 24-h Holter | Aupraventricular and ventricular arrhytmias | 0--3-12 months | 
| All-cause death or re-admission | All-cause death or >24h re-hospitalization due to all-cause | 12 months | 
| Cardiovascular death or re-admission | Cardiovascular death or >24h re-hospitalization due to cardiovascular causes | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial infarction, Cardiac regeneration, Cardiac surgery