Clinical trial NCT02998853: Non Culprit Functional Evaluation With 3D Angio QFR in STEMI PCI Procedure
Official title: Reliability of 3D Angio QFR Evaluation of Non Culprit Stenoses in STEMI Patients During First Acute Interventional Procedure: Comparison With Staged Procedure FFR
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: STEMI - ST Elevation Myocardial Infarction
Percutaneous Coronary Intervention
Coronary Artery Disease
Keywords: Non culprit
STEMI PCI
angio QFR
FFR
Staged procedure
Lead sponsor: Azienda Ospedaliera Sant'Anna e San Sebastiano
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive STEMI patients with at least one non culprit artery with stenosis \>50%.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 1 - 15 days
Secondary outcomes:
measure: 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
timeFrame: 0-15 days
measure: Diagnostic accuracy of TIMI flow based for computing QFR in staged study in comparison with Hyperemic FFR in the same lesion
timeFrame: 0-1 hour
Other outcomes:
Locations:
city: Caserta
country: Italy
facility: Azienda Ospedaliera Sant-Anna e San Sebastiano
Study officials:
affiliation: Azienda Ospedaliera Sant'Anna e San Sebastiano
name: Domenico Di Girolamo
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliera Sant'Anna e San Sebastiano
name: Giuseppe MERCONE, MD
role: PRINCIPAL_INVESTIGATOR
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