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

July 30, 2024 updated by: Antoni Bayés Genís
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
        • Contact:
          • Sebastián Consulta de Investigación Cardiología
          • Phone Number: 0034 915868000
        • Principal Investigator:
          • Francisco Fernández Avilés, PhD
      • Murcia, Spain, 30120
        • Not yet recruiting
        • Hospital Clinico Universitario Virgen de la Arrixaca
        • Contact:
          • Maria Teresa Pérez Martínez
          • Phone Number: 0034 968369500
        • Principal Investigator:
          • Domingo Pascual Figal, PhD
      • Málaga, Spain, 29010
        • Not yet recruiting
        • Hospital Virgen de la Victoria
        • Contact:
          • Manuel Jiménez Navarro
          • Phone Number: 0034 951032000
        • Principal Investigator:
          • Eduardo de Teresa, PhD
      • Palma De Mallorca, Spain
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clínico Universitario de Valencia
        • Principal Investigator:
          • Julio Núñez, PhD
        • Contact:
      • Valladolid, Spain, 47003
        • Recruiting
        • Hospital Clinico Universitario de Valladolid
        • Contact:
        • Principal Investigator:
          • Alberto San Román
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Principal Investigator:
          • Pablo Avanzas, PhD
        • Contact:
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Germans Trias University Hospital; Germans Trias Research Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antoni Bayes-Genis, PhD
        • Sub-Investigator:
          • Paloma Gastelurrutia, PhD
        • Sub-Investigator:
          • Josep Lupon, PhD
        • Sub-Investigator:
          • Maria Luisa Cámara, PhD
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta de Hierro
        • Principal Investigator:
          • Pablo García Pavía, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AGTP-treatment
Patients in which the non-revascularizable area will be covered by the adipose graft and the revascularizable area will be treated with the normal procedure.
Procedure: AGTP-treatment
Patients with a myocardial necrosis candidates for revascularization of other myocardial areas, will be enrolled. The non-revascularizable area will be covered with the adipose graft and the revascularizable area will be treated with the normal procedure (by-pass).
Other: Control
Patients in with the non-revascularizable area will be left untouched and the revascularizable area will be treated normally.
Other: Control
Patients with a myocardial necrosis, candidates for revascularization of other myocardial areas, will be enrolled. The non-revascularizable area will be left untouched and the revascularizable area will be treated normally (by-pass).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in necrotic mass ratio (%) by gadolinium retention.
Time Frame: 0-3-12 months
necrotic mass ratio (%)
0-3-12 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in infarct size: left ventricular necrotic mass
Time Frame: 0-3-12 months
grams
0-3-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antoni Bayés Genís

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

May 26, 2016

First Submitted That Met QC Criteria

June 8, 2016

First Posted (Estimated)

June 14, 2016

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICOR-2016-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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