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NCT Number: NCT02798276

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

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AGTP-treatment

Procedure

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).

Control

Other

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).

Primary outcomes

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

    Time frame: 0-3-12 months

    necrotic mass ratio (%)

Secondary outcomes

  1. Improvement in regional contractibility by NMR

    Time frame: 0-3-12 months

    regional contractibility

  2. 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 (%)

  3. Changes in functional parameters by Nuclear Magnetic Resonance: ventricular volumes

    Time frame: 0-3-12 months

    LVESV, LVEDV, RVESV, RVEDV (mL)

  4. Changes in functional parameters by NMR: Cardiac output

    Time frame: 0-3-12 months

    L/min

  5. Levels of natriuretic peptides

    Time frame: 0-1 week-3-12 months

    NTproBNP

  6. Arrhythmia by 24-h Holter

    Time frame: 0--3-12 months

    Aupraventricular and ventricular arrhytmias

  7. All-cause death or re-admission

    Time frame: 12 months

    All-cause death or >24h re-hospitalization due to all-cause

  8. Cardiovascular death or re-admission

    Time frame: 12 months

    Cardiovascular death or >24h re-hospitalization due to cardiovascular causes

Other outcomes

  1. Changes in infarct size: left ventricular necrotic mass

    Time frame: 0-3-12 months

    grams

Sponsors and collaborators

Lead sponsor

Antoni Bayés Genís

Unknown

Registry information

Acronym: AGTP II

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Jun 14, 2016
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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