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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | Patients in which the non-revascularizable area will be left untouched and the revascularizable area will be treated normally. |
|
| adiFLAP | Experimental | Patients in which the non-revascularizable area will be covered by the adiFLAP and the revascularizable area will be treated with the normal procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Germans Trias Research Institute; Germans Trias University Hospital | Badalona | Barcelona | 08916 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21576133 | Background | Galvez-Monton C, Prat-Vidal C, Roura S, Farre J, Soler-Botija C, Llucia-Valldeperas A, Diaz-Guemes I, Sanchez-Margallo FM, Aris A, Bayes-Genis A. Transposition of a pericardial-derived vascular adipose flap for myocardial salvage after infarct. Cardiovasc Res. 2011 Sep 1;91(4):659-67. doi: 10.1093/cvr/cvr136. Epub 2011 May 16. | |
| 22137092 |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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|
| Control | Other | 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). |
|
| Galvez-Monton C, Prat-Vidal C, Roura S, Soler-Botija C, Llucia-Valldeperas A, Diaz-Guemes I, Sanchez-Margallo FM, Bayes-Genis A. Post-infarction scar coverage using a pericardial-derived vascular adipose flap. Pre-clinical results. Int J Cardiol. 2013 Jun 20;166(2):469-74. doi: 10.1016/j.ijcard.2011.11.019. Epub 2011 Dec 2. |
| 27322478 | Derived | Bayes-Genis A, Gastelurrutia P, Camara ML, Teis A, Lupon J, Llibre C, Zamora E, Alomar X, Ruyra X, Roura S, Revilla A, San Roman JA, Galvez-Monton C. First-in-man Safety and Efficacy of the Adipose Graft Transposition Procedure (AGTP) in Patients With a Myocardial Scar. EBioMedicine. 2016 May;7:248-54. doi: 10.1016/j.ebiom.2016.03.027. Epub 2016 Apr 10. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |