Clinical Research Directory
Browse clinical research sites, groups, and studies.
Functional Assessment in Elderly MI Patients With Multivessel Disease
Sponsor: Consorzio Futuro in Ricerca
Summary
Elderly patients presenting with myocardial infarction (MI) and multivessel disease are the highest risk population with the worst prognosis. No trial has ever been designed to optimize their outcome. The actual real-life standard of care is, in the best of the cases, culprit only revascularization. However, real-life registries show that outcome of MI elderly patients treated with this strategy is far from being optimal with at least a 15% rate of cardiac death or myocardial infarction at 1 year. To date, studies on this population have been focused on devices (bare metal stent vs biodegradable drug eluting stent) or on dual antiplatelet regimen (long vs short) and no study was focused on evaluating if complete revascularization is able to improve the prognosis in these patients. The contemporary complete revascularization is represented by a functionally-driven revascularization that recently showed to significantly reduce myocardial infarction rate and outperformed an angio-complete revascularization. Thus, our hypothesis is that a functionally-driven complete revascularization in elderly patients with MI and multivessel disease may improve prognosis compared to the actual standard of care in these patients, namely culprit only revascularization. Being a "strategy" trial, we identified the patient-oriented composite endpoint (POCE) as primary outcome of interest (all cause death, any MI, any stroke, any revascularization). Several pre-specified substudies have been planned. A detailed list of the substudies is available in the website of the trial (http://www.thefiretrial.com)
Official title: Functional Versus Culprit-only Revascularization in Elderly Patients With Myocardial Infarction and Multivessel Disease
Key Details
Gender
All
Age Range
75 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1445
Start Date
2019-07-15
Completion Date
2026-10-03
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Culprit-only revascularization
Implantation of drug eluting stents with biodegradable polymer with struts ≤65 μ in the culprit lesion of the MI. Each patient should receive revascularization with Supraflex stent or its newer versions
Complete functionally-guided revascularization
Implantation of drug eluting stents with biodegradable polymer with struts ≤65 μ in the culprit lesion of the MI and in all non culprit lesions with positive functional assessment. Each patient should receive revascularization with Supraflex stent or its newer versions
Locations (37)
Ospedale Maggiore
Bologna, Bologna, Italy
AOU Ferrara
Ferrara, Ferrara, Italy
Maria Cecilia Hospital
Cotignola, Ravenna, Italy
Ospedale Santa Maria delle Croci
Ravenna, Ravenna, Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, Reggio Emilia, Italy
Ospedale Infermi
Rimini, Rimini, Italy
ASP Agrigento
Agrigento, Italy
AOU Sant'Anna e San Sebastiano
Caserta, Italy
Casa di Cura San Michele Maddaloni
Caserta, Italy
AO Cannizzaro
Catania, Italy
Ospedale della Misericordia
Grosseto, Italy
Ospedale Sant.Andrea
La Spezia, Italy
AOU Gaetano Martino
Messina, Italy
Ospedale dell'Angelo
Mestre, Italy
Ospedale Civile di Baggiovara
Modena, Italy
Ospedale Santa Croce
Moncalieri, Italy
AOU Giaccone
Palermo, Italy
AOU Sant'Andrea
Roma, Italy
Ospedale SS Annunziata
Savigliano, Italy
Ospedale Umberto I
Syracuse, Italy
Ospedale di Rivoli
Torino, Italy
AOU Integrata di Verona
Verona, Italy
Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii
Krosno, Poland
Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii
Nowy Sącz, Poland
Centrum Kardiologii Inwazyjnej Elektroterapii i Angiologii
Oświęcim, Poland
Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii
Pińczów, Poland
Podkarpackie Centrum Interwencji Sercowo-Naczyniowych
Sanok, Poland
Complejo Hospitalario de La Coruna
A Coruña, Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, Spain
Hospital Universitario Lucus Augusti
Lugo, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, Spain
Hospital Universitario La FE
Valencia, Spain
Hospital Clinico Universitario
Valladolid, Spain
Hospital Alvaro Conqueiro de Vigo
Vigo, Spain