NCT03772743: FIRE

Functional Assessment in Elderly MI Patients With Multivessel Disease

Active, enrolled NA Last updated 2 April 2026

What this trial tests

NA trial testing Culprit-only revascularization in Myocardial Infarction in 1,445 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

15 July 2019

Primary endpoint
30 October 2022

3 October 2026

Quick facts

Lead sponsor	Consorzio Futuro in Ricerca
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,445
Start date	15 July 2019
Primary completion	30 October 2022
Estimated completion	3 October 2026
Sites	37 locations across Italy, Spain, Poland

Drugs / interventions tested

• Culprit-only revascularization
• Complete functionally-guided revascularization

Conditions studied

• Myocardial Infarction — all drugs for Myocardial Infarction →

Sponsor

Consorzio Futuro in Ricerca

Who can join

75 and older, any sex, with Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Complete or Culprit-Only PCI in Older Patients with Myocardial Infarction.
   Biscaglia S, Guiducci V, Escaned J, Moreno R, et al · · 2023 · cited 213× · PMID 37634150 · DOI 10.1056/nejmoa2300468
2. Physiology-guided revascularization versus optimal medical therapy of nonculprit lesions in elderly patients with myocardial infarction: Rationale and design of the FIRE trial.
   Biscaglia S, Guiducci V, Santarelli A, Amat Santos I, et al · · 2020 · cited 34× · PMID 32822656 · DOI 10.1016/j.ahj.2020.08.007
3. Frailty in patients admitted to hospital for acute coronary syndrome: when, how and why?
   Tonet E, Pavasini R, Biscaglia S, Campo G. · · 2019 · cited 26× · PMID 30923544 · DOI 10.11909/j.issn.1671-5411.2019.02.005
4. Complete vs Culprit-Only Revascularization in Older Patients With Myocardial Infarction With or Without ST-Segment Elevation.
   Cocco M, Campo G, Guiducci V, Casella G, et al · · 2024 · cited 22× · PMID 39217557 · DOI 10.1016/j.jacc.2024.07.028
5. Complete vs Culprit-Only Revascularization in Older Patients With Myocardial Infarction and High Bleeding Risk: A Randomized Clinical Trial.
   Erriquez A, Campo G, Guiducci V, Escaned J, et al · · 2024 · cited 19× · PMID 38717753 · DOI 10.1001/jamacardio.2024.0804
6. Ultrathin Struts Drug-Eluting Stents: A State-of-the-Art Review.
   Leone A, Simonetti F, Avvedimento M, Angellotti D, et al · · 2022 · cited 18× · PMID 36143162 · DOI 10.3390/jpm12091378
7. QFR for the Revascularization of Nonculprit Vessels in MI Patients: Insights From the FIRE Trial.
   Erriquez A, Campo G, Guiducci V, Casella G, et al · · 2024 · cited 17× · PMID 38752972 · DOI 10.1016/j.jcin.2024.04.022
8. Timing of Complete Revascularization in Patients with STEMI and Multivessel Disease: A Systematic Review and Meta-Analysis.
   Panuccio G, Salerno N, De Rosa S, Torella D. · · 2023 · cited 12× · PMID 39077406 · DOI 10.31083/j.rcm2402058