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

This study is ongoing, but not recruiting participants.
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: November 13, 2013
Last verified: November 2013

November 14, 2011
November 13, 2013
January 2012
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT01473433 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Pericardic Adipose Pedicle Transposition Over the Myocardial Infarct (adiFLAP Trial)
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)

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Myocardial Infarction
  • 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.
  • 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).
  • Control
    Patients in which the non-revascularizable area will be left untouched and the revascularizable area will be treated normally.
    Intervention: Other: Control
  • 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.
    Intervention: Procedure: Pericardial adipose pedicle (adiFLAP) transposition.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10
Not Provided
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01473433
ICREC-2011-02
Not Provided
Antoni Bayés Genís, Germans Trias i Pujol Hospital
Germans Trias i Pujol Hospital
Not Provided
Not Provided
Germans Trias i Pujol Hospital
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP