Pericardic Adipose Pedicle Transposition Over the Myocardial Infarct (adiFLAP Trial)

Germans Trias i Pujol Hospital10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Myocardial Infarction

Interventions

Pericardial adipose pedicle (adiFLAP) transposition.PROCEDURE

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.

ControlOTHER

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Germans Trias Research Institute; Germans Trias University Hospital

Badalona, Barcelona, Spain

Outcomes

Primary Outcomes

Appearance of adverse effects derived from the procedure (7 days after the surgical procedure and 1 year follow-up).

Time frame: 12 months

Secondary Outcomes

Improvement of cardiac function as changes in clinical variables, cardiac magnetic resonance imaging and echocardiography, and biochemical variables (NTproBNP and high sensitivity troponin T).

Time frame: 12 months

Data from ClinicalTrials.gov

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