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Myocardial InfarctionAGTP IINCT02798276

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

A study testing AGTP-treatment in people with Myocardial Infarction, run by Antoni Bayés Genís at 9 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Infarction
What is being tested?
AGTP-treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
9 sitesSpain
Study dates
1 Mar 2017to 20 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • > 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

Who cannot join

  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Spain9 sites

  • Germans Trias University Hospital; Germans Trias Research Institute

    Badalona, Barcelona, 08916

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Hospital Virgen de la Victoria

    Málaga, 29010

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia, 30120

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Son Espases Hospital

    Palma de Mallorca

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003

Other trials in Spain

About this study

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.

Being tested
AGTP-treatment, Control
Keywords
Myocardial infarction, Cardiac regeneration, Cardiac surgery
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AGTP-treatmentProcedure or surgery

    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).

  • ControlOther

    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).

Study groups in NCT02798276
Study groupRoleWhat they receive
AGTP-treatmentExperimentalPatients in which the non-revascularizable area will be covered by the adipose graft and the revascularizable area will be treated with the normal procedure.
Receives: Procedure: AGTP-treatment
ControlOtherPatients in with the non-revascularizable area will be left untouched and the revascularizable area will be treated normally.
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    necrotic mass ratio (%)

    Measured: 0-3-12 months

Secondary outcomes (8)

  1. Improvement in regional contractibility by NMR

    regional contractibility

    Measured: 0-3-12 months

  2. Changes in functional parameters by Nuclear Magnetic Resonance: ventricular ejection fraction

    Left Ventricular Ejection Fraction, Right Ventricular Ejection Fraction (%)

    Measured: 0-3-12 months

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

    LVESV, LVEDV, RVESV, RVEDV (mL)

    Measured: 0-3-12 months

  4. Changes in functional parameters by NMR: Cardiac output

    L/min

    Measured: 0-3-12 months

  5. Levels of natriuretic peptides

    NTproBNP

    Measured: 0-1 week-3-12 months

  6. Arrhythmia by 24-h Holter

    Aupraventricular and ventricular arrhytmias

    Measured: 0--3-12 months

  7. All-cause death or re-admission

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

    Measured: 12 months

  8. Cardiovascular death or re-admission

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2016 (estimated)
  2. Study start1 Mar 2017
  3. Primary completion20 Nov 2025
  4. Study completion20 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02798276
Sponsor's protocol ID
ICOR-2016-01
Acronym
AGTP II
Status last verified
Sep 2026
First submitted
26 May 2016
Last updated
3 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bayes-Genis A, Galvez-Monton C, Prat-Vidal C, Soler-Botija C. Cardiac adipose tissue: a new frontier for cardiac regeneration? Int J Cardiol. 2013 Jul 15;167(1):22-5. doi: 10.1016/j.ijcard.2012.05.082. Epub 2012 Jun 17.

    PubMed 22709728

  • Galvez-Monton C, Prat-Vidal C, Roura S, Soler-Botija C, Llucia-Valldeperas A, Diaz-Guemes I, Sanchez-Margallo FM, Bayes-Genis A. Post-infarction scar coverage using a pericardial-derived vascular adipose flap. Pre-clinical results. Int J Cardiol. 2013 Jun 20;166(2):469-74. doi: 10.1016/j.ijcard.2011.11.019. Epub 2011 Dec 2.

    PubMed 22137092

  • Galvez-Monton C, Prat-Vidal C, Roura S, Farre J, Soler-Botija C, Llucia-Valldeperas A, Diaz-Guemes I, Sanchez-Margallo FM, Aris A, Bayes-Genis A. Transposition of a pericardial-derived vascular adipose flap for myocardial salvage after infarct. Cardiovasc Res. 2011 Sep 1;91(4):659-67. doi: 10.1093/cvr/cvr136. Epub 2011 May 16.

    PubMed 21576133

  • Bayes-Genis A, Gastelurrutia P, Camara ML, Teis A, Lupon J, Llibre C, Zamora E, Alomar X, Ruyra X, Roura S, Revilla A, San Roman JA, Galvez-Monton C. First-in-man Safety and Efficacy of the Adipose Graft Transposition Procedure (AGTP) in Patients With a Myocardial Scar. EBioMedicine. 2016 May;7:248-54. doi: 10.1016/j.ebiom.2016.03.027. Epub 2016 Apr 10.

    PubMed 27322478

  • Ma H, Liu J, Qian L. Fat for fostering: Regenerating injured heart using local adipose tissue. EBioMedicine. 2016 May;7:25-6. doi: 10.1016/j.ebiom.2016.03.024. Epub 2016 Mar 20. No abstract available.

    PubMed 27322455

  • Gastelurrutia P, Galvez-Monton C, Camara ML, Bustamante-Munguira J, Garcia-Pavia P, Avanzas P, Alberto San Roman J, Pascual-Figal D, Teresa E, Crespo-Leiro MG, Manito N, Nunez J, Fernandez-Aviles F, Caballero A, Teis A, Lupon J, Brugada R, Martin C, Silva J, Revilla-Orodea A, Canovas SJ, Melero JM, Cuenca-Castillo JJ, Gonzalez-Pinto A, Bayes-Genis A. Rationale and design of a multicentre, prospective, randomised, controlled clinical trial to evaluate the efficacy of the adipose graft transposition procedure in patients with a myocardial scar: the AGTP II trial. BMJ Open. 2017 Aug 4;7(8):e017187. doi: 10.1136/bmjopen-2017-017187.

    PubMed 28780562

Questions about this trial

What is this clinical trial studying?

A study testing AGTP-treatment in people with Myocardial Infarction, run by Antoni Bayés Genís at 9 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in necrotic mass ratio (%) by gadolinium retention. (time frame: 0-3-12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02798276, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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