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
- Diseases
- Coronary artery disease
- 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
Sites (37)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Complejo Hospitalario de la Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Hospital General Universitario de Ciudad Real Coordinator of this site? Confirm its status | Ciudad Real | Spain | Unknown status |
| Hospital Universitario Lucus Augusti Coordinator of this site? Confirm its status | Lugo | Spain | Unknown status |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Complejo Hospitalario Universitario de Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| Hospital Universitario la Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Clinico Universitario Coordinator of this site? Confirm its status | Valladolid | Spain | Unknown status |
| Hospital Alvaro Conqueiro de Vigo Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
| ASP Agrigento Coordinator of this site? Confirm its status | Agrigento | Italy | Unknown status |
| Ospedale Maggiore Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| AOU Sant'Anna e San Sebastiano Coordinator of this site? Confirm its status | Caserta | Italy | Unknown status |
| Casa di Cura San Michele Maddaloni Coordinator of this site? Confirm its status | Caserta | Italy | Unknown status |
| AO Cannizzaro Coordinator of this site? Confirm its status | Catania | Italy | Unknown status |
| Maria Cecilia Hospital Coordinator of this site? Confirm its status | Cotignola | Italy | Unknown status |
| AOU Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Unknown status |
| Ospedale Della Misericordia Coordinator of this site? Confirm its status | Grosseto | Italy | Unknown status |
| Ospedale Sant.Andrea Coordinator of this site? Confirm its status | La Spezia | Italy | Unknown status |
| AOU Gaetano Martino Coordinator of this site? Confirm its status | Messina | Italy | Unknown status |
| Ospedale dell'Angelo Coordinator of this site? Confirm its status | Mestre | Italy | Unknown status |
| Ospedale Civile di Baggiovara Coordinator of this site? Confirm its status | Modena | Italy | Unknown status |
| Ospedale Santa Croce Coordinator of this site? Confirm its status | Moncalieri | Italy | Unknown status |
| AOU Giaccone Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| Ospedale Santa Maria delle Croci Coordinator of this site? Confirm its status | Ravenna | Italy | Unknown status |
| Arcispedale Santa Maria Nuova Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Unknown status |
| Ospedale "Infermi" Coordinator of this site? Confirm its status | Rimini | Italy | Unknown status |
| AOU Sant'Andrea Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Ospedale SS Annunziata Coordinator of this site? Confirm its status | Savigliano | Italy | Unknown status |
| Ospedale Umberto I Coordinator of this site? Confirm its status | Syracuse | Italy | Unknown status |
| Ospedale di Rivoli Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| AOU Integrata di Verona Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
| Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii Coordinator of this site? Confirm its status | Krosno | Poland | Unknown status |
| Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii Coordinator of this site? Confirm its status | Nowy Sącz | Poland | Unknown status |
| Centrum Kardiologii Inwazyjnej Elektroterapii i Angiologii Coordinator of this site? Confirm its status | Oświęcim | Poland | Unknown status |
| Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii Coordinator of this site? Confirm its status | Pińczów | Poland | Unknown status |
| Podkarpackie Centrum Interwencji Sercowo-Naczyniowych Coordinator of this site? Confirm its status | Sanok | Poland | Unknown status |
Related publications
- Evaluating the Impact of Enhanced Stent Visualization on PCI Outcomes in Older Patients With Multivessel Disease.Catheter Cardiovasc Interv · 2026 · PMID 42627239
- Diabetes does not attenuate the benefit of physiology-guided complete revascularization in older patients with myocardial infarction.Cardiovasc Diabetol · 2026 · PMID 41981421
- Consistent benefit of physiology-guided complete revascularization across the spectrum of frailty in older patients with myocardial infarction: a prespecified analysis of the FIRE trial.Age Ageing · 2026 · PMID 41965249
This page is information, not medical advice. Discuss any trial with your doctor.