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Functional Assessment in Elderly MI Patients With Multivessel Disease (FIRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772743
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Consorzio Futuro in Ricerca

Brief 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)


Condition or disease Intervention/treatment Phase
Myocardial Infarction Other: Culprit-only revascularization Other: Complete functionally-guided revascularization Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1385 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All comers, prospective, randomized, multicenter, open-label trial with blinded adjudicated evaluation of outcomes (PROBE).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Functional Versus Culprit-only Revascularization in Elderly Patients With Myocardial Infarction and Multivessel Disease
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Culprit-only revascularization
All patients randomized to culprit only revascularization must not undergo percutaneous coronary intervention (PCI) any lesion except from the culprit lesion already treated at the moment of the randomization. Staged procedures are considered protocol violation.
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

Complete functionally-guided revascularization
Patients who are randomized to this strategy will receive revascularization of the culprit lesion and guided by functional assessment on all non-culprit lesions. Functional evaluation is mandatory for all stenosis with diameter stenosis % between 50 and 90% at visual estimation. Revascularization must be guided by functional assessment on all vessels. The system utilized to obtain functional evaluation is left to Operator's discretion. PCI is allowed only if functional evaluation is positive according to the threshold of the chosen functional system. It is suggested to achieve functional complete revascularization within the index procedure, while it is mandatory to obtain it within the index hospitalization.
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




Primary Outcome Measures :
  1. Patient oriented cardiac events [ Time Frame: 1-year ]
    cumulative occurrence of all-cause death, any MI, any stroke, any coronary revascularization


Secondary Outcome Measures :
  1. Patient oriented cardiac events [ Time Frame: 3-year ]
    cumulative occurrence of all-cause death, any MI, any stroke, any coronary revascularization

  2. Patient oriented cardiac events [ Time Frame: 5-year ]
    cumulative occurrence of all-cause death, any MI, any stroke, any coronary revascularization

  3. Daily activities and quality of life [ Time Frame: 1-year ]
    quality of life in study groups as assessed by EQol-5D questionnaire

  4. Physical performance [ Time Frame: 1-year ]
    quality of life in study groups as assessed by Short Physical Performance Battery

  5. Residual angina [ Time Frame: 1-year ]
    residual angina in study groups as assessed by Seattle Angina Questionnaire

  6. Bleeding complications [ Time Frame: 1-year ]
    BARC 3-5 bleedings

  7. Cardiac death [ Time Frame: 1-year ]
    cumulative occurrence of cardiac death



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients ≥75 years AND
  2. MI (ST-segment elevation or not ST.segment elevation MI) with indication to invasive management AND
  3. 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
  4. Successful treatment of culprit lesion

Exclusion Criteria:

  1. Planned surgical revascularization
  2. Non-cardiovascular co-morbidity reducing life expectancy to < 1 year
  3. Any factor precluding 1-year follow-up
  4. Prior Coronary Artery Bypass Graft (CABG) Surgery
  5. Impossibility to identify a clear culprit lesion
  6. Non culprit lesion located in the left main

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772743


Contacts
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Contact: Veronica Lodolini, Bs 0532236450 ext +39 ldlvnc@unife.it
Contact: Roberta Piadena 0223992999 ext +39 roberta.piadena@advicepharma.com

Locations
Show Show 29 study locations
Sponsors and Collaborators
Consorzio Futuro in Ricerca
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Responsible Party: Consorzio Futuro in Ricerca
ClinicalTrials.gov Identifier: NCT03772743    
Other Study ID Numbers: 2018
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be available after motivated request to the Executive Committee of the study. All requests will be evaluated for acceptance. Positive evaluation by the Executive Committee is mandatory before data release
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After the publication of the manuscripts reporting the primary outcome and the prespecified substudies
URL: http://thefiretrial.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Consorzio Futuro in Ricerca:
older adults
multivessel coronary disease
intracoronary physiology
functional assessment
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases