Efficacy of the Adipose Graft Transposition Procedure (AGTP) in Patients With a Myocardial Scar: The AGTP II Trial

Antoni Bayés Genís9 sites in 1 country70 target enrollmentMarch 1, 2017

ConditionsMyocardial Infarction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myocardial Infarction
Sponsor: Antoni Bayés Genís
Enrollment: 70
Locations: 9
Primary Endpoint: Changes in necrotic mass ratio (%) by gadolinium retention.
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this trial is to evaluate the efficacy of a pericardial adipose graft transposition (Adipose Graft Trasposition Procedure, AGTP) for the improvement of cardiac function in patients with a chronic myocardial infarction. Preclinical studies in the porcine model of myocardial infarction have shown that the AGTP reduces infarct area and improves cardiac function. A first-in-man clinical (NCT01473433) trial showed that the AGTP is safe in patients.

Registry

clinicaltrials.gov

Start Date

March 1, 2017

End Date

November 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Antoni Bayés Genís

Responsible Party

Sponsor Investigator

Principal Investigator

Antoni Bayés Genís

Antoni Bayes-Genis, Chief of the Cardiology Service

Germans Trias i Pujol Hospital

Eligibility Criteria

Inclusion Criteria

•\> 18 years of age, capable of giving informed consent.
•Q wave in the ECG
•Myocardial infarct \>=50% transmularity by NMR non revascularizable (for transmurality or bad vessel).
•Candidate to bypass for other myocardial areas

Exclusion Criteria

•Severe non cardiac co-morbidity with a reduction of life expectancy of less than 1 year
•Severe valvular disease candidate for surgical restoration
•Candidate to ventricular remodeling
•Contraindication for NMR
•Severe renal or hepatic failure
•Abnoraml laboratory tests (no explanation at inclusion)
•Previous cardiac intervention
•Pregnant or breast feeding women

Outcomes

Primary Outcomes

Changes in necrotic mass ratio (%) by gadolinium retention.

Time Frame: 0-3-12 months

necrotic mass ratio (%)

Secondary Outcomes

Changes in functional parameters by Nuclear Magnetic Resonance: ventricular volumes(0-3-12 months)
Improvement in regional contractibility by NMR(0-3-12 months)
Levels of natriuretic peptides(0-1 week-3-12 months)
All-cause death or re-admission(12 months)
Changes in functional parameters by Nuclear Magnetic Resonance: ventricular ejection fraction(0-3-12 months)
Arrhythmia by 24-h Holter(0--3-12 months)
Changes in functional parameters by NMR: Cardiac output(0-3-12 months)
Cardiovascular death or re-admission(12 months)