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NCT03772743Active, not recruiting

Functional Assessment in Elderly MI Patients With Multivessel Disease

Functional Versus Culprit-only Revascularization in Elderly Patients With Myocardial Infarction and Multivessel Disease

Source: ClinicalTrials.gov · Last updated 2 Apr 2026

Brief summary (registry, in English)

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)

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
1445 (actual)
First submitted
9 Dec 2018
Start date
15 Jul 2019
Primary completion date
30 Oct 2022
Lead sponsor
Consorzio Futuro in Ricerca
NCT number
NCT03772743

What you commit to

  • Study type: Interventional
  • Participants enrolled: 1445
  • From 15 Jul 2019 to the primary completion date, 30 Oct 2022
  • 37 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Planned surgical revascularization
  • Prior Coronary Artery Bypass Graft (CABG) Surgery

Other

  • Non-cardiovascular co-morbidity reducing life expectancy to \< 1 year
  • Any factor precluding 1-year follow-up
  • Impossibility to identify a clear culprit lesion
  • Non culprit lesion located in the left main

Who the study is looking for

  • Patients ≥75 years AND
  • MI (ST-segment elevation or not ST.segment elevation MI) with indication to invasive management AND
  • Multi-vessel disease defined as at least 1 non-culprit coronary artery lesion at least 2.5 mm in diameter deemed at visual estimation with a diameter stenosis % ranging from 50 to 99% amenable to successful treatment with PCI AND
  • Successful treatment of culprit lesion

Age in the registry: 75 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (37)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Complejo Hospitalario de la Coruña
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A CoruñaSpainUnknown status
Hospital General Universitario de Ciudad Real
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Ciudad RealSpainUnknown status
Hospital Universitario Lucus Augusti
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LugoSpainUnknown status
Hospital Clínico San Carlos
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MadridSpainUnknown status
Hospital General Universitario Gregorio Marañón
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MadridSpainUnknown status
Hospital Universitario La Paz
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MadridSpainUnknown status
Complejo Hospitalario Universitario de Santiago
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Santiago de CompostelaSpainUnknown status
Hospital Universitario la Fe
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ValenciaSpainUnknown status
Hospital Clinico Universitario
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ValladolidSpainUnknown status
Hospital Alvaro Conqueiro de Vigo
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VigoSpainUnknown status
ASP Agrigento
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AgrigentoItalyUnknown status
Ospedale Maggiore
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BolognaItalyUnknown status
AOU Sant'Anna e San Sebastiano
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CasertaItalyUnknown status
Casa di Cura San Michele Maddaloni
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CasertaItalyUnknown status
AO Cannizzaro
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CataniaItalyUnknown status
Maria Cecilia Hospital
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CotignolaItalyUnknown status
AOU Ferrara
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FerraraItalyUnknown status
Ospedale Della Misericordia
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GrossetoItalyUnknown status
Ospedale Sant.Andrea
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La SpeziaItalyUnknown status
AOU Gaetano Martino
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MessinaItalyUnknown status
Ospedale dell'Angelo
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MestreItalyUnknown status
Ospedale Civile di Baggiovara
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ModenaItalyUnknown status
Ospedale Santa Croce
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MoncalieriItalyUnknown status
AOU Giaccone
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PalermoItalyUnknown status
Ospedale Santa Maria delle Croci
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RavennaItalyUnknown status
Arcispedale Santa Maria Nuova
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Reggio EmiliaItalyUnknown status
Ospedale "Infermi"
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RiminiItalyUnknown status
AOU Sant'Andrea
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RomaItalyUnknown status
Ospedale SS Annunziata
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SaviglianoItalyUnknown status
Ospedale Umberto I
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SyracuseItalyUnknown status
Ospedale di Rivoli
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TorinoItalyUnknown status
AOU Integrata di Verona
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VeronaItalyUnknown status
Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii
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KrosnoPolandUnknown status
Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii
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Nowy SączPolandUnknown status
Centrum Kardiologii Inwazyjnej Elektroterapii i Angiologii
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OświęcimPolandUnknown status
Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii
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PińczówPolandUnknown status
Podkarpackie Centrum Interwencji Sercowo-Naczyniowych
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SanokPolandUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.