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

Azienda Ospedaliera Sant'Anna e San Sebastiano120 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

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

Interventions

QFR measurement by dedicated workstation on xrays angio selected runsOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Azienda Ospedaliera Sant-Anna e San Sebastiano

Caserta, Caserta, Italy

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 1 - 15 days

Secondary Outcomes

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

Time frame: 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

Time frame: 0-1 hour

Central Contacts

Domenico Di Girolamo, MD

CONTACT

+390823232550 mimmo.digirolamo@gmail.com

Giuseppe Mercone, MD

CONTACT

+390823232550 mimmo.digirolamo@gmail.com

Data from ClinicalTrials.gov

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