NCT02798276 Efficacy of the Adipose Graft Transposition Procedure (AGTP) in Patients With a Myocardial Scar: The AGTP II Trial
| NCT ID | NCT02798276 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Antoni Bayés Genís |
| Condition | Myocardial Infarction |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2017-03-01 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2017-03-01 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT02798276 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02798276 currently recruiting?
Yes, NCT02798276 is actively recruiting participants. Visit ClinicalTrials.gov or contact Antoni Bayés Genís to inquire about joining.
Where is the NCT02798276 trial being conducted?
This trial is being conducted at Badalona, Spain, Majadahonda, Spain, Oviedo, Spain, Madrid, Spain and 5 additional locations.
Who is sponsoring the NCT02798276 clinical trial?
NCT02798276 is sponsored by Antoni Bayés Genís. The trial plans to enroll 70 participants.