Myocardial Infarction
Conditions
Keywords
Myocardial infarction, Cardiac regeneration, Cardiac surgery
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.
Interventions
PROCEDUREAGTP-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).
OTHERControl
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).
Sponsors
Antoni Bayés Genís
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in necrotic mass ratio (%) by gadolinium retention. | 0-3-12 months | necrotic mass ratio (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in regional contractibility by NMR | 0-3-12 months | regional contractibility |
| Changes in functional parameters by Nuclear Magnetic Resonance: ventricular ejection fraction | 0-3-12 months | Left Ventricular Ejection Fraction, Right Ventricular Ejection Fraction (%) |
| Changes in functional parameters by Nuclear Magnetic Resonance: ventricular volumes | 0-3-12 months | LVESV, LVEDV, RVESV, RVEDV (mL) |
| Changes in functional parameters by NMR: Cardiac output | 0-3-12 months | L/min |
| Levels of natriuretic peptides | 0-1 week-3-12 months | NTproBNP |
| Arrhythmia by 24-h Holter | 0--3-12 months | Aupraventricular and ventricular arrhytmias |
| All-cause death or re-admission | 12 months | All-cause death or \>24h re-hospitalization due to all-cause |
| Cardiovascular death or re-admission | 12 months | Cardiovascular death or \>24h re-hospitalization due to cardiovascular causes |
Countries
Spain
Outcome results
None listed