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Functional Coronary Angiography Guided Revascularization in STEMI (AIR-STEMI)

Primary Purpose

Myocardial Infarction

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Angiography-guided PCI
Angiography-derived FFR PCI indication and planning
Sponsored by
University Hospital of Ferrara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Percutaneous coronary intervention, Angiography-derived Fractional Flow Reserve, Multivessel disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ST-segment elevation myocardial infarction with indication to invasive management 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 Successful treatment of culprit lesion Exclusion Criteria: Planned surgical revascularization Left main as non-culprit lesion Non-cardiovascular co-morbidity reducing life expectancy to < 1 year Any factor precluding 1-year follow-up Prior Coronary Artery Bypass Graft (CABG) Surgery Impossibility to identify a clear culprit lesion Presence of a chronic total occlusion (CTO)

Sites / Locations

  • AUSL Bologna Ospedale MaggioreRecruiting
  • Azienda Ospedaliero Universitaria di FerraraRecruiting
  • Ospedale Civile di BaggiovaraRecruiting
  • AUSL PiacenzaRecruiting
  • Azienda Ospedaliero Universitaria di ParmaRecruiting
  • Arcispedale Santa Maria Nuova di Reggio EmiliaRecruiting
  • AUSL Romagna Ospedale degli Infermi RiminiRecruiting
  • Ospedale Santa Maria della Misericordia RovigoRecruiting
  • Ospedale dell'Angelo MestreRecruiting
  • Ospedale Mater Salutis LegnagoRecruiting
  • Azienda Ospedaliero Universitaria Integrata di VeronaRecruiting
  • Ospedale Santa Maria GorettiRecruiting
  • Ospedale Maggiore della Carità NovaraRecruiting
  • AUSL Romagna Santa Maria delle Croci RavennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Angiography-guided PCI

Angiography-derived FFR PCI indication and planning

Arm Description

Patients will receive PCI of all lesions with at least 50% diameter stenosis at visual estimation. PCI plan and assessment of PCI results will be based on angiography.

Patients will receive PCI of all lesions with at least 50% diameter stenosis and positive angiography-derived FFR value (≤0.80). PCI planning will be based on the pullback curve obtained by angiography-derived FFR to obtain an optimal post-PCI physiology.

Outcomes

Primary Outcome Measures

Primary Efficacy Outcome: Patient Oriented Composite Outcome
Cumulative occurrence of mortality, cerebrovascular accident, reinfarction, or ischemia-driven revascularization
Primary Safety Outcome: Major Bleeding and Contrast - Associated Acute Kidney Injury
Cumulative occurrence of contrast-associated acute kidney injury and bleeding BARC 3-5

Secondary Outcome Measures

Main Secondary Outcome: Cardiovascular Mortality and Myocardial Infarction
Cumulative occurrence of cardiovascular mortality and myocardial infarction

Full Information

First Posted
March 22, 2023
Last Updated
October 10, 2023
Sponsor
University Hospital of Ferrara
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1. Study Identification

Unique Protocol Identification Number
NCT05818475
Brief Title
Functional Coronary Angiography Guided Revascularization in STEMI
Acronym
AIR-STEMI
Official Title
Functional Coronary Angiography to Indicate and Guide Revascularization in STEMI Patients With Multivessel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
May 8, 2026 (Anticipated)
Study Completion Date
May 8, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Ferrara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this multicenter randomized clinical trial is to test the superiority in terms of efficacy of the Angiography-derived fractional flow reserve (AIR) over that based on conventional angiography (ANGIO) strategy in the management of non-culprit lesions in STEMI patients with multivessel disease. The main questions it aims to answer are: is an Angiography-derived fractional flow reserve strategy superior to a conventional angiography strategy in reducing the occurrence of the composite efficacy endpoint of all-cause death, myocardial infarction, cerebrovascular accident, or ischemia-driven revascularization. is an Angiography-derived fractional flow reserve strategy superior to a conventional angiography strategy in reducing the occurrence of the composite safety endpoint of of contrast-associated acute kidney injury and Bleeding Academic Research Consortium (BARC) type 3-5. Participants will be randomized after the successful treatment of the culprit lesion to one of the two strategies and prospectively followed-up.
Detailed Description
Reperfusion of the culprit lesion through primary PCI is the standard of care in ST-segment elevation myocardial infarction (STEMI) patients, regardless of their age. The actual gold standard for the management of non-culprit lesions in STEMI patients with multivessel disease (MVD) is angiography-guided complete revascularization. The Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease after Primary PCI for STEMI (COMPLETE) trial randomized 4 041 patients with STEMI and MVD. The main finding was the highly significant reduction of new MI occurrence in the complete group (7.9% vs 5.4%, hazard ratio (HR) 0.68, 95% CI 0.53-0.87, p=0.002). Revascularization was obtained largely by angiographic evaluation (>99%). After COMPLETE, the subsequent step was to ascertain which complete revascularization strategy should be pursued. In particular, physiology-guided revascularization was compared to an angio-guided strategy. The advantages of physiology against angiography are related to: a) lower number of vessels treated, b) lower number of stents implanted; c) avoidance of a second procedure in negative fractional flow reserve (FFR) patients during primary PCI; d) possibility to optimize the procedure from the physiological standpoint after percutaneous coronary intervention (PCI). In the Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction (FLOWER-MI), patients with STEMI and multivessel disease who had undergone successful PCI of the infarct-related artery were randomly assigned to receive complete revascularization guided by either FFR or angiography. The primary outcome was a composite of death from any cause, nonfatal myocardial infarction, or unplanned hospitalization leading to urgent revascularization at 1 year. FFR-guided revascularization was associated with lower number of stents implanted per patient (1.01±0.99 versus 1.50±0.86). During follow-up, a primary outcome event occurred in 32 of 586 patients (5.5%) in the FFR-guided group and in 24 of 577 patients (4.2%) in the angiography-guided group (hazard ratio, 1.32; 95% confidence interval, 0.78 to 2.23; P = 0.31). Death occurred in 9 patients (1.5%) in the FFR-guided group and in 10 (1.7%) in the angiography-guided group; nonfatal myocardial infarction in 18 (3.1%) and 10 (1.7%), respectively; and unplanned hospitalization leading to urgent revascularization in 15 (2.6%) and 11 (1.9%), respectively. The results of the FLOWER-MI trial may suggest that physiology can provide a similar outcome if compared to a conventional angio-guided approach. However, some limitation should be acknowledged: i) rate of events was three-times lower than expected suggesting both a selection bias and the need of a higher number of patients to demonstrate any difference among the two groups; ii) all patients in the FFR-group received a staged procedure to perform physiology assessment diluting one of the major advantages in FFR negative patients, namely the avoidance of a second procedure if physiology is negative; iii) in 16% of patients in the physio-guided group FFR was not performed before PCI, whereas in 82% of patients it was not performed after PCI; iv) even if FFR was associated with lower PCIs, periprocedural MI was three times higher if compared to the angio-group, suggesting its possible underreporting in the angio-group. After the COMPLETE trial2, the actual standard of care in the management of STEMI patients with MVD is complete revascularization based on angiography. However, this approach may lead to over- or under-estimation of lesions in a relevant portion of patients with negative impact on prognosis. Invasive physiology has been consistently shown to be superior if compared to angio-guided strategy, but it is underutilized in clinical practice mainly due to feasibility issues. A functional coronary angiography could overcome the applicability issues related to invasive physiology. In addition, it is particularly appealing in the evaluation of non-culprit lesions since: It is possible to acquire projection during primary PCI and perform the analysis off-line In case of negative assessment, the patient can avoid a second procedure to invasively measure physiology It is possible to optimize most of the procedures by the physiological standpoint through the utilization of the virtual-PCI planner tool pre-PCI without the need to repeat physiology after PCI. It has been recently shown that if compared to an angio-guided approach, Angiography-derived FFR was able to reduce the incidence of spontaneous MI by 36% Therefore, a strategy based on functional coronary angiography to indicate and guide PCI could be superior if compared to an angio-guided strategy both from the efficacy (CV death, cerebrovascular accident, MI and ischemia-driven revascularization) and from the safety (BARC 3-5, contrast-associated acute kidney injury) standpoint.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Percutaneous coronary intervention, Angiography-derived Fractional Flow Reserve, Multivessel disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Angiography-guided PCI
Arm Type
Active Comparator
Arm Description
Patients will receive PCI of all lesions with at least 50% diameter stenosis at visual estimation. PCI plan and assessment of PCI results will be based on angiography.
Arm Title
Angiography-derived FFR PCI indication and planning
Arm Type
Experimental
Arm Description
Patients will receive PCI of all lesions with at least 50% diameter stenosis and positive angiography-derived FFR value (≤0.80). PCI planning will be based on the pullback curve obtained by angiography-derived FFR to obtain an optimal post-PCI physiology.
Intervention Type
Other
Intervention Name(s)
Angiography-guided PCI
Intervention Description
Non-culprit lesion treatment will be based on visual estimation by angiography. The evaluation of PCI result will be also based only on angiography.
Intervention Type
Other
Intervention Name(s)
Angiography-derived FFR PCI indication and planning
Intervention Description
Non-culprit lesion treatment will be based on angiography-derived FFR result. In case of positive assessment, PCI will be planned according to the virtual PCI plan based on the physiology pullback curve.
Primary Outcome Measure Information:
Title
Primary Efficacy Outcome: Patient Oriented Composite Outcome
Description
Cumulative occurrence of mortality, cerebrovascular accident, reinfarction, or ischemia-driven revascularization
Time Frame
through study completion, an average of 18 months
Title
Primary Safety Outcome: Major Bleeding and Contrast - Associated Acute Kidney Injury
Description
Cumulative occurrence of contrast-associated acute kidney injury and bleeding BARC 3-5
Time Frame
through study completion, an average of 18 months
Secondary Outcome Measure Information:
Title
Main Secondary Outcome: Cardiovascular Mortality and Myocardial Infarction
Description
Cumulative occurrence of cardiovascular mortality and myocardial infarction
Time Frame
through study completion, an average of 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ST-segment elevation myocardial infarction with indication to invasive management 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 Successful treatment of culprit lesion Exclusion Criteria: Planned surgical revascularization Left main as non-culprit lesion Non-cardiovascular co-morbidity reducing life expectancy to < 1 year Any factor precluding 1-year follow-up Prior Coronary Artery Bypass Graft (CABG) Surgery Impossibility to identify a clear culprit lesion Presence of a chronic total occlusion (CTO)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martina Viola, Bsc
Phone
+39532236874
Email
martina.viola@unife.it
First Name & Middle Initial & Last Name or Official Title & Degree
Veronica Lodolini, Bsc
Phone
+39532236450
Email
ldlvnc@unife.it
Facility Information:
Facility Name
AUSL Bologna Ospedale Maggiore
City
Bologna
State/Province
BO
ZIP/Postal Code
40133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giulia Bugani, MD
Facility Name
Azienda Ospedaliero Universitaria di Ferrara
City
Ferrara
State/Province
FE
ZIP/Postal Code
44124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simone Biscaglia, MD
Phone
+39532239883
Email
bscsmn@unife.it
First Name & Middle Initial & Last Name & Degree
Martina Viola, BsC
Phone
+39532236874
Email
martina.viola@unife.it
Facility Name
Ospedale Civile di Baggiovara
City
Baggiovara
State/Province
MO
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Ruozzi
Facility Name
AUSL Piacenza
City
Piacenza
State/Province
PC
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guido Rusticali
Facility Name
Azienda Ospedaliero Universitaria di Parma
City
Parma
State/Province
PR
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giampaolo Niccoli
Facility Name
Arcispedale Santa Maria Nuova di Reggio Emilia
City
Reggio Emilia
State/Province
RE
ZIP/Postal Code
42123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Mantovani, MD
Facility Name
AUSL Romagna Ospedale degli Infermi Rimini
City
Rimini
State/Province
RN
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mila Menozzi
Facility Name
Ospedale Santa Maria della Misericordia Rovigo
City
Rovigo
State/Province
RO
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimo Giordan
Facility Name
Ospedale dell'Angelo Mestre
City
Mestre
State/Province
VE
ZIP/Postal Code
30100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Barbierato
Facility Name
Ospedale Mater Salutis Legnago
City
Legnago
State/Province
VR
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriele Venturi
Facility Name
Azienda Ospedaliero Universitaria Integrata di Verona
City
Verona
State/Province
VR
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Scarsini
Facility Name
Ospedale Santa Maria Goretti
City
Latina
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Versaci
Facility Name
Ospedale Maggiore della Carità Novara
City
Novara
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Domenico D'Amario
Facility Name
AUSL Romagna Santa Maria delle Croci Ravenna
City
Ravenna
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manfredi Arioti

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The present study is powered for the patient oriented composite endpoint, but not for CV death and MI. In order to obtain compelling evidence on this latter endpoint, the data of the present study will be merged with those of randomized clinical trials sharing the same inclusion and exclusion criteria, randomization and study interventions.
IPD Sharing Time Frame
Data will be available for individual patient level analysis in order to merge our data with other trials sharing inclusion and exclusion criteria. Data will be available after the completion of the primary endpoint.
IPD Sharing Access Criteria
Direct request to study Principal Investigator.
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Functional Coronary Angiography Guided Revascularization in STEMI

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