Pericardic Adipose Pedicle Transposition Over the Myocardial Infarct (adiFLAP Trial)
adiFLAP
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)
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2012
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2011
CompletedFirst Posted
Study publicly available on registry
November 17, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJuly 24, 2015
July 1, 2015
2.8 years
November 14, 2011
July 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Appearance of adverse effects derived from the procedure (7 days after the surgical procedure and 1 year follow-up).
12 months
Secondary Outcomes (1)
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
Study Arms (2)
Control
OTHERPatients in which the non-revascularizable area will be left untouched and the revascularizable area will be treated normally.
adiFLAP
EXPERIMENTALPatients in which the non-revascularizable area will be covered by the adiFLAP and the revascularizable area will be treated with the normal procedure.
Interventions
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.
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Previous cardiac intervention.
- High surgical risk (Euroscore 2).
- Pregnant or breast feeding women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Germans Trias Research Institute; Germans Trias University Hospital
Badalona, Barcelona, 08916, Spain
Related Publications (3)
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.
PMID: 21576133BACKGROUNDGalvez-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.
PMID: 22137092BACKGROUNDBayes-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.
PMID: 27322478DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of the Cardiology Service
Study Record Dates
First Submitted
November 14, 2011
First Posted
November 17, 2011
Study Start
January 1, 2012
Primary Completion
November 1, 2014
Study Completion
December 1, 2014
Last Updated
July 24, 2015
Record last verified: 2015-07