Using fat grafts to improve heart function after a heart attack
Efficacy of the Adipose Graft Transposition Procedure (AGTP) in Patients With a Myocardial Scar: The AGTP II Trial
This study is testing whether a new procedure that uses fat from around the heart can help improve heart function in people who have had a heart attack.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Germans Trias i Pujol Hospital Academic / other |
| Locations | 9 sites (Badalona, Barcelona and 8 other locations) |
| Trial ID | NCT02798276 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of the Adipose Graft Transposition Procedure (AGTP) in enhancing cardiac function in patients with chronic myocardial infarction. The AGTP involves transplanting adipose tissue from the pericardium to the damaged heart area, aiming to reduce scar tissue and improve heart performance. Previous studies in animal models have shown promising results, and an initial human trial indicated that the procedure is safe. This trial will compare the outcomes of patients receiving AGTP treatment to those receiving standard care.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a significant myocardial infarction that is not amenable to revascularization.
Not a fit: Patients with severe non-cardiac comorbidities or those requiring other cardiac interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this procedure could significantly improve heart function and quality of life for patients with chronic myocardial infarction.
How similar studies have performed: Previous studies have shown success with similar approaches in animal models, but this trial represents a first-in-man evaluation of the AGTP.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Badalona, Barcelona and 8 other locations
- Germans Trias University Hospital; Germans Trias Research Institute — Badalona, Barcelona, Spain (Recruiting)
- Hospital Universitario Puerta de Hierro — Majadahonda, Madrid, Spain (Recruiting)
- Hospital Universitario Central de Asturias — Oviedo, Principality of Asturias, Spain (Recruiting)
- Hospital General Universitario Gregorio Marañón — Madrid, Spain (Recruiting)
- Hospital Virgen de la Victoria — Málaga, Spain (Not_yet_recruiting)
- Hospital Clínico Universitario Virgen de la Arrixaca — Murcia, Spain (Not_yet_recruiting)
- Son Espases Hospital — Palma de Mallorca, Spain (Recruiting)
- Hospital Clínico Universitario de Valencia — Valencia, Spain (Recruiting)
- Hospital Clínico Universitario de Valladolid — Valladolid, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.