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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Trial to Evaluate the Safety and Efficacy of a New Surgical Approach to Cardiac Regeneration: Pericardic Adipose Pedicle Transposition Over the Myocardial Infarct (adiFLAP Trial)

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Procedure: Pericardial adipose pedicle (adiFLAP) transposition.
* Other: Control


Participation Criteria
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Eligibility Criteria
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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.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>Patients in which the non-revascularizable area will be left untouched and the revascularizable area will be treated normally. | Other: Control<br>* 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).<br>|
| Experimental: adiFLAP<br>Patients in which the non-revascularizable area will be covered by the adiFLAP and the revascularizable area will be treated with the normal procedure. | Procedure: Pericardial adipose pedicle (adiFLAP) transposition.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appearance of adverse effects derived from the procedure (7 days after the surgical procedure and 1 year follow-up). |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Regenerative medicine, Myocardial infarction