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

Not Applicable

Recruiting

• Conditions: Myocardial Infarction

• Registration Number: NCT02798276
• Lead Sponsor: Antoni Bayés Genís

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-26
• Study First Submitted QC: 2016-06-08
• Study First Posted: 2016-06-14
• Study Start: 2017-03-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Primary Completion: 2025-10
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in necrotic mass ratio (%) by gadolinium retention.	0-3-12 months	necrotic mass ratio (%)

Secondary Outcome Measures

Name	Time	Method
Changes in functional parameters by Nuclear Magnetic Resonance: ventricular volumes	0-3-12 months	LVESV, LVEDV, RVESV, RVEDV (mL)
Improvement in regional contractibility by NMR	0-3-12 months	regional contractibility
Levels of natriuretic peptides	0-1 week-3-12 months	NTproBNP
All-cause death or re-admission	12 months	All-cause death or \>24h re-hospitalization due to all-cause
Changes in functional parameters by Nuclear Magnetic Resonance: ventricular ejection fraction	0-3-12 months	Left Ventricular Ejection Fraction, Right Ventricular Ejection Fraction (%)
Arrhythmia by 24-h Holter	0--3-12 months	Aupraventricular and ventricular arrhytmias
Changes in functional parameters by NMR: Cardiac output	0-3-12 months	L/min
Cardiovascular death or re-admission	12 months	Cardiovascular death or \>24h re-hospitalization due to cardiovascular causes

Trial Locations

Locations (9)

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

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

Hospital Universitario Puerta de Hierro; 🇪🇸 Majadahonda, Madrid, Spain

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital Clínico Universitario Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Hospital Virgen de la Victoria; 🇪🇸 Málaga, Spain

Son Espases Hospital; 🇪🇸 Palma De Mallorca, Spain

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Spain