Actively Recruiting
Efficacy of the Adipose Graft Transposition Procedure (AGTP) in Patients With a Myocardial Scar: The AGTP II Trial
Led by Antoni Bayés Genís · Updated on 2024-07-31
70
Participants Needed
9
Research Sites
452 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of the Adipose Graft Transposition Procedure (AGTP) in Patients With a Myocardial Scar: The AGTP II Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over 18 years of age and able to give informed consent
- Presence of a Q wave in the ECG
- Myocardial infarction with at least 50% wall thickness involvement by NMR that is not revascularizable
- Candidate for bypass surgery for other myocardial areas
You will not qualify if you...
- Severe non-cardiac illness reducing life expectancy to less than 1 year
- Severe valve disease requiring surgical repair
- Candidate for ventricular remodeling surgery
- Contraindications to NMR imaging
- Severe kidney or liver failure
- Abnormal laboratory test results without explanation at inclusion
- Previous heart surgery or intervention
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 9 locations
1
Germans Trias University Hospital; Germans Trias Research Institute
Badalona, Barcelona, Spain, 08916
Actively Recruiting
2
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Actively Recruiting
3
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain, 33011
Actively Recruiting
4
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Actively Recruiting
5
Hospital Virgen de la Victoria
Málaga, Spain, 29010
Not Yet Recruiting
6
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain, 30120
Not Yet Recruiting
7
Son Espases Hospital
Palma de Mallorca, Spain
Actively Recruiting
8
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
9
Hospital Clínico Universitario de Valladolid
Valladolid, Spain, 47003
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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