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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Pericardial adipose pedicle (adiFLAP) transposition.
Control
Sponsored by
Germans Trias i Pujol Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Regenerative medicine, Myocardial infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Germans Trias Research Institute; Germans Trias University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control

adiFLAP

Arm Description

Patients in which the non-revascularizable area will be left untouched and the revascularizable area will be treated normally.

Patients in which the non-revascularizable area will be covered by the adiFLAP and the revascularizable area will be treated with the normal procedure.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 14, 2011
Last Updated
July 23, 2015
Sponsor
Germans Trias i Pujol Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01473433
Brief Title
Pericardic Adipose Pedicle Transposition Over the Myocardial Infarct (adiFLAP Trial)
Acronym
adiFLAP
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

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Germans Trias i Pujol Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Regenerative medicine, Myocardial infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
Patients in which the non-revascularizable area will be left untouched and the revascularizable area will be treated normally.
Arm Title
adiFLAP
Arm Type
Experimental
Arm Description
Patients in which the non-revascularizable area will be covered by the adiFLAP and the revascularizable area will be treated with the normal procedure.
Intervention Type
Procedure
Intervention Name(s)
Pericardial adipose pedicle (adiFLAP) transposition.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
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).
Primary Outcome Measure Information:
Title
Appearance of adverse effects derived from the procedure (7 days after the surgical procedure and 1 year follow-up).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Germans Trias Research Institute; Germans Trias University Hospital
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
21576133
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.
Results Reference
background
PubMed Identifier
22137092
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.
Results Reference
background
PubMed Identifier
27322478
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.
Results Reference
derived

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

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