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

Phase 1

Completed

• Conditions: Myocardial Infarction
• Interventions: Procedure: Pericardial adipose pedicle (adiFLAP) transposition.; Other: Control

• Registration Number: NCT01473433
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2011-11-14
• Study First Submitted QC: 2011-11-16
• Study First Posted: 2011-11-17
• Study Start: 2012-01
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-23
• Last Update Posted: 2015-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
adiFLAP	Pericardial adipose pedicle (adiFLAP) transposition.	Patients in which the non-revascularizable area will be covered by the adiFLAP and the revascularizable area will be treated with the normal procedure.
Control	Control	Patients in which the non-revascularizable area will be left untouched and the revascularizable area will be treated normally.

Primary Outcome Measures

Name	Time	Method
Appearance of adverse effects derived from the procedure (7 days after the surgical procedure and 1 year follow-up).	12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Germans Trias Research Institute; Germans Trias University Hospital; 🇪🇸 Badalona, Barcelona, Spain