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ACTIVE NOT RECRUITING
NCT03772743
NA

Functional Assessment in Elderly MI Patients With Multivessel Disease

Sponsor: Consorzio Futuro in Ricerca

View on ClinicalTrials.gov

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

Interventions

OTHER

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

OTHER

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