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)

Germans Trias i Pujol Hospital1 site in 1 country10 target enrollmentJanuary 2012

ConditionsMyocardial Infarction

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Myocardial Infarction
Sponsor: Germans Trias i Pujol Hospital
Enrollment: 10
Locations: 1
Primary Endpoint: Appearance of adverse effects derived from the procedure (7 days after the surgical procedure and 1 year follow-up).
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

December 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Germans Trias i Pujol Hospital

Responsible Party

Principal Investigator

Antoni Bayés Genís

Chief of the Cardiology Service

Germans Trias i Pujol Hospital

Eligibility 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.

Outcomes

Primary Outcomes

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

Time Frame: 12 months

Secondary Outcomes

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)