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

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ClinicalTrials.gov Identifier: NCT01473433
Recruitment Status : Completed
First Posted : November 17, 2011
Last Update Posted : July 24, 2015
Sponsor:
Information provided by (Responsible Party):
Antoni Bayés Genís, Germans Trias i Pujol Hospital

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Procedure: Pericardial adipose pedicle (adiFLAP) transposition. Other: Control Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : January 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arm Intervention/treatment
Control
Patients in which the non-revascularizable area will be left untouched and the revascularizable area will be treated normally.
Other: Control
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).
Experimental: adiFLAP
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.
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.



Primary Outcome Measures :
  1. 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 Measures :
  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). [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01473433


Locations
Spain
Germans Trias Research Institute; Germans Trias University Hospital
Badalona, Barcelona, Spain, 08916
Sponsors and Collaborators
Germans Trias i Pujol Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Antoni Bayés Genís, Chief of the Cardiology Service, Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier: NCT01473433     History of Changes
Other Study ID Numbers: ICREC-2011-02
First Posted: November 17, 2011    Key Record Dates
Last Update Posted: July 24, 2015
Last Verified: July 2015

Keywords provided by Antoni Bayés Genís, Germans Trias i Pujol Hospital:
Regenerative medicine
Myocardial infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases