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

This study is currently recruiting participants.
Verified May 2012 by Germans Trias i Pujol Hospital
Sponsor:
Information provided by (Responsible Party):
Antoni Bayés Genís, Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT01473433
First received: November 14, 2011
Last updated: May 8, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention Phase
Myocardial Infarction
 Procedure: Pericardial adipose pedicle (adiFLAP) transposition.
Other: Control
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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)

Resource links provided by NLM:

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

Further study details as provided by Germans Trias i Pujol Hospital:

Primary Outcome Measures:
  • Appearance of adverse effects derived from the procedure (7 days after the surgical procedure and 1 year follow-up). [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

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). [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: January 2012
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473433

Contacts
Contact: Paloma Gastelurrutia 0034 934978662 pgastelurrutia@gmail.com
Contact: Laura Astier 0034 934978662 grupicrec@gmail.com

Locations
Spain
Germans Trias Research Institute; Germans Trias University Hospital Recruiting
Badalona, Barcelona, Spain, 08916
Contact: Paloma Gastelurrutia     0034 934978662     pgastelurrutia@gmail.com    
Contact: Laura Astier     0034 934978662     grupicrec@gmail.com    
Principal Investigator: Antoni Bayes-Genis            
Sub-Investigator: Xavier Ruyra            
Sub-Investigator: Maria Luisa Cámara            
Sub-Investigator: Albert Teis            
Sub-Investigator: Paloma Gastelurrutia            
Sub-Investigator: Laura Astier            
Sub-Investigator: Cristina Prat-Vidal            
Sub-Investigator: Carolina Gálvez-Montón            
Sponsors and Collaborators
Germans Trias i Pujol Hospital
  More Information

Publications:

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
Study First Received: November 14, 2011
Last Updated: May 8, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by 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

ClinicalTrials.gov processed this record on June 18, 2013