Non Culprit Functional Evaluation With 3D Angio QFR in STEMI PCI Procedure

Study Overview
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Brief Summary
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Reliability of 3D angio QFR functional evaluation of all non culprit lesions >50% in STEMI patients during first acute procedure

Detailed Description
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3DAngio QFR is an angiographic based tool for coronary stenosis functional assessment: it is validated versus Adenosine FFR(ADOFFR) by several studies (FAVOR, VIRTU-1) ; in particular post contrast QFR (cQFR) showed a very good correlation with ADOFFR. Furthermore ADOFFR in non culprit vessel in acute stage of STEMI correlates well with ADOFFR of the same non culprit lesion in staged procedure. Aim of the study is to find a valid correlation between cQFR in acute study and ADOFFR in the staged procedure. A positive result may lead to a fast, easy and cost effective acute functional non culprit lesions evaluation during acute procedure for STEMI patients, selecting those,if any, to be treated immediately or in a staged procedure.

Official Title
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Reliability of 3D Angio QFR Evaluation of Non Culprit Stenoses in STEMI Patients During First Acute Interventional Procedure: Comparison With Staged Procedure FFR

Conditions
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STEMI - ST Elevation Myocardial Infarction, Percutaneous Coronary Intervention, Coronary Artery Disease

Intervention / Treatment
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* Other: QFR measurement by dedicated workstation on xrays angio selected runs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: STEMI/NSTEMI pts with at least 1 non culprit lesion > 50% Age > 18 years Able to provide signed informed consent Angiographic inclusion criteria: Indication for FFR in at least one stenosis: Diameter stenosis of 50%-90% by visual estimate Reference vessel size > 2 mm in stenotic segment by visual estimate Exclusion Criteria: Severe asthma or severe chronic obstructive pulmonary disease Severe heart failure (NYHA≥III) S-creatinine>150µmol/L or GFR<45 ml/kg/1.73m2 Allergy to contrast media or adenosine Atrial fibrillation Angiographic exclusion criteria: poor coronary opacification marked overlapping marked tortuosity angio acquisition protocol incomplete

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: QFR measurement by dedicated workstation on xrays angio selected runs|The patient undergoes coronary angiography; if at least one stenosis from 40 to 90% in non culprit is present and FFR is indicated by guidelines the patient is enrolled to 3d Angio QFR evaluation; no adjunctive invasive procedures are needed for QFR measurements|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of TIMI flow based with contrast hyperemia QFR in acute study comparison to FFR in staged procedure reported as positive and negative likelihood ratio in the same lesion | Diagnostic performance of QFR in comparison to FFR reported as positive and negative likelihood ratio | 1 - 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of TIMI flow based for computing QFR in acute study in comparison with TIMI flow based for computing QFR in staged in the same lesion | Diagnostic accuracy of TIMI flow based for computing QFR in acute study in comparison with TIMI flow based for computing QFR in staged in the same lesion | 0-15 days | 
| Diagnostic accuracy of TIMI flow based for computing QFR in staged study in comparison with Hyperemic FFR in the same lesion | Diagnostic accuracy of TIMI flow based for computing QFR in acute study in comparison with TIMI flow based for computing QFR in staged in the same lesion | 0-1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FFR, Non culprit, STEMI PCI, angio QFR, Staged procedure