Myocardial Infarction
Conditions
Keywords
Regenerative medicine, Myocardial infarction
Brief summary
The purpose of this trial is to evaluate safety and efficacy of a pericardial adipose pedicle transposition (adiFLAP) for the improvement of cardiac function in patients with a chronic myocardial infarct. Preclinical studies in the porcine model of myocardial infarction have shown that AdiFLAP reduces infarct area.
Detailed description
This novel intervention consists of the pericardial isolation of adipose tissue maintaining its vascularization to create an adipose flap (adiFLAP) and its transposition fully covering infarcted myocardium.
Interventions
PROCEDUREPericardial adipose pedicle (adiFLAP) transposition.
Patients with a established transmural necrosis, candidates for revascularization of other myocardial areas, will be enrolled. The non-revascularizable area will be covered by the adiFLAP and the revascularizable area will be treated with the normal procedure. A non-revascularizable area will be considered whenever a transmural necrosis is detected by means of gadolinium contrast using MRI.
OTHERControl
Patients with a established transmural 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
Germans Trias i Pujol Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Established transmural myocardial infarction non candidate to revascularization (\>3 months-old) * Candidate to coronary by-pass for other territories different from the previous transmural infarct. * \> 18 years of age, male or female, capable of giving an informed consent.
Exclusion criteria
* Severe co-morbidity associated with a reduction in life expectancy of less than 1 year. * Severe valvular disease candidate for surgical restoration. * Candidate to ventricular remodeling. * Contraindication for NMR (creatinin clearance \<30 ml/min/1.73m2, metallic implants, claustrophobia). * Severe renal or hepatic failure. * Abnormal laboratory tests (no explanation at the time of inclusion). * Previous cardiac intervention. * High surgical risk (Euroscore 2). * Pregnant or breast feeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Appearance of adverse effects derived from the procedure (7 days after the surgical procedure and 1 year follow-up). | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of cardiac function as changes in clinical variables, cardiac magnetic resonance imaging and echocardiography, and biochemical variables (NTproBNP and high sensitivity troponin T). | 12 months |
Countries
Spain
Outcome results
None listed