Clinical trial NCT01473433: Pericardic Adipose Pedicle Transposition Over the Myocardial Infarct (adiFLAP Trial)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Myocardial Infarction
Keywords: Regenerative medicine
Myocardial infarction
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
First posted: 2011-11-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Appearance of adverse effects derived from the procedure (7 days after the surgical procedure and 1 year follow-up).
timeFrame: 12 months
Secondary outcomes:
measure: Improvement of cardiac function as changes in clinical variables, cardiac magnetic resonance imaging and echocardiography, and biochemical variables (NTproBNP and high sensitivity troponin T).
timeFrame: 12 months
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Germans Trias Research Institute; Germans Trias University Hospital
state: Barcelona
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.