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

Last updated: July 30, 2024
Sponsor: Antoni Bayés Genís
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Disease

Coronary Artery Disease

Angina

Treatment

AGTP-treatment

Control

Clinical Study ID

NCT02798276
ICOR-2016-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • > 18 years of age, capable of giving informed consent.

  • Q wave in the ECG

  • Myocardial infarct >=50% transmularity by NMR non revascularizable (fortransmurality or bad vessel).

  • Candidate to bypass for other myocardial areas

Exclusion

Exclusion Criteria:

  • Severe non cardiac co-morbidity with a reduction of life expectancy of less than 1year

  • 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

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: AGTP-treatment
Phase:
Study Start date:
March 01, 2017
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • Hospital São João, Faculty of Medicine, University of Porto

    Porto, 4099-002
    Portugal

    Site Not Available

  • Hospital Universitario Central de Asturias

    Oviedo, Asturias 33011
    Spain

    Active - Recruiting

  • Germans Trias University Hospital; Germans Trias Research Institute

    Badalona, Barcelona 08916
    Spain

    Active - Recruiting

  • Hospital de Bellvitge

    L'Hospitalet de Llobregat, Barcelona 08907
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid 28222
    Spain

    Active - Recruiting

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz de Tenerife, Tenerife 38010
    Spain

    Site Not Available

  • Complexo Hospitalario Universitario A Coruña

    A Coruña, 15006
    Spain

    Site Not Available

  • Hospital Universitari de Girona Doctor Josep Trueta

    Girona, 17007
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia, 30120
    Spain

    Site Not Available

  • Hospital Virgen de la Victoria

    Málaga, 29010
    Spain

    Site Not Available

  • Son Espases Hospital

    Palma De Mallorca,
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003
    Spain

    Active - Recruiting

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