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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02998853

Enrollment

120

Registered

2016-12-21

Start date

2016-11-30

Completion date

2017-12-31

Last updated

2016-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Non culprit, STEMI PCI, angio QFR, FFR, Staged procedure

Brief summary

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

Detailed description

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.

Interventions

OTHERQFR 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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	1 - 15 days	Diagnostic performance of QFR in comparison to FFR reported as positive and negative likelihood ratio

Secondary

Measure	Time frame	Description
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 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 staged study in comparison with Hyperemic FFR in the same lesion	0-1 hour	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

Countries

Italy

Contacts

Primary ContactDomenico Di Girolamo, MD

mimmo.digirolamo@gmail.com+390823232550

Backup ContactGiuseppe Mercone, MD