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

Myocardial Infarction Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01473433
• Other study ID #: ICREC-2011-02
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 14, 2011
• Last updated: July 23, 2015
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: July 2015
• Source: Germans Trias i Pujol Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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).

Locations

Country	Name	City	State
Spain	Germans Trias Research Institute; Germans Trias University Hospital	Badalona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Gálvez-Montón C, Prat-Vidal C, Roura S, Farré J, Soler-Botija C, Llucià-Valldeperas A, Díaz-Güemes I, Sánchez-Margallo FM, Arís 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. — View Citation

Gálvez-Montón C, Prat-Vidal C, Roura S, Soler-Botija C, Llucià-Valldeperas A, Díaz-Güemes I, Sánchez-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Appearance of adverse effects derived from the procedure (7 days after the surgical procedure and 1 year follow-up).		12 months	Yes
Secondary	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	No