CClinicalTrials.gg
Status unknownNCT02998853Updated Dec 21, 2016

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

An observational study in STEMI - ST Elevation Myocardial Infarction, Percutaneous Coronary Intervention and Coronary Artery Disease, sponsored by Azienda Ospedaliera Sant'Anna e San Sebastiano. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-12-21.

Sponsored by Azienda Ospedaliera Sant'Anna e San Sebastiano · Observational

The sponsor has not verified this record recently (last verified Dec 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years to 85 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

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

Keywords

  • Non culprit
  • STEMI PCI
  • angio QFR
  • FFR
  • Staged procedure
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In context

Coronary Artery Disease

5,600 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.

This study's planned enrollment of 120 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

This is the only study on the registry with Azienda Ospedaliera Sant'Anna e San Sebastiano as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Consecutive STEMI patients with at least one non culprit artery with stenosis >50%.

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

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

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

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

    Also known as: 3d Angio QFR evaluation

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What researchers measure

Primary outcomes

  1. 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

  1. 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

    Time frame: 0-15 days

  2. 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

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Study locations

1 of 1 sites recruiting
  • Azienda Ospedaliera Sant-Anna e San Sebastiano
    Caserta, 81100, Italy
    Recruiting
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References and documents

Publications

  • Tu S, Westra J, Yang J, von Birgelen C, Ferrara A, Pellicano M, Nef H, Tebaldi M, Murasato Y, Lansky A, Barbato E, van der Heijden LC, Reiber JHC, Holm NR, Wijns W; FAVOR Pilot Trial Study Group. Diagnostic Accuracy of Fast Computational Approaches to Derive Fractional Flow Reserve From Diagnostic Coronary Angiography: The International Multicenter FAVOR Pilot Study. JACC Cardiovasc Interv. 2016 Oct 10;9(19):2024-2035. doi: 10.1016/j.jcin.2016.07.013. PubMed 27712739 ↗
  • Safi M, Eslami V, Namazi MH, Vakili H, Saadat H, Alipourparsa S, Adibi A, Movahed MR. Visual-Functional Mismatch Between Coronary Angiography, Fractional Flow Reserve, and Quantitative Coronary Angiography. Int J Angiol. 2016 Dec;25(4):229-234. doi: 10.1055/s-0035-1569992. Epub 2015 Dec 31. PubMed 27867288 ↗
  • Gaur S, Taylor CA, Jensen JM, Botker HE, Christiansen EH, Kaltoft AK, Holm NR, Leipsic J, Zarins CK, Achenbach S, Khem S, Wilk A, Bezerra HG, Lassen JF, Norgaard BL. FFR Derived From Coronary CT Angiography in Nonculprit Lesions of Patients With Recent STEMI. JACC Cardiovasc Imaging. 2017 Apr;10(4):424-433. doi: 10.1016/j.jcmg.2016.05.019. Epub 2016 Oct 12. PubMed 27743953 ↗
  • Indolfi C, Mongiardo A, Spaccarotella C, Torella D, Caiazzo G, Polimeni A, Sorrentino S, Micieli M, Sabatino J, Curcio A, De Rosa S. The instantaneous wave-free ratio (iFR) for evaluation of non-culprit lesions in patients with acute coronary syndrome and multivessel disease. Int J Cardiol. 2015 Jan 15;178:46-54. doi: 10.1016/j.ijcard.2014.03.210. Epub 2014 Oct 28. PubMed 25464218 ↗
  • Sulimov DS, Abdel-Wahab M, Richardt G. Fractional Flow Reserve in Acute Myocardial Infarction: A Guide for Non-Culprit Lesions? Cardiol Ther. 2015 Jun;4(1):39-46. doi: 10.1007/s40119-015-0040-4. Epub 2015 Jun 9. PubMed 26055262 ↗
  • Engstrom T, Kelbaek H, Helqvist S, Hofsten DE, Klovgaard L, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aaroe J, Jensen SE, Raungaard B, Kober L; DANAMI-3-PRIMULTI Investigators. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015 Aug 15;386(9994):665-71. doi: 10.1016/s0140-6736(15)60648-1. PubMed 26347918 ↗
  • Morris PD, Ryan D, Morton AC, Lycett R, Lawford PV, Hose DR, Gunn JP. Virtual fractional flow reserve from coronary angiography: modeling the significance of coronary lesions: results from the VIRTU-1 (VIRTUal Fractional Flow Reserve From Coronary Angiography) study. JACC Cardiovasc Interv. 2013 Feb;6(2):149-57. doi: 10.1016/j.jcin.2012.08.024. PubMed 23428006 ↗
  • Morris PD, van de Vosse FN, Lawford PV, Hose DR, Gunn JP. "Virtual" (Computed) Fractional Flow Reserve: Current Challenges and Limitations. JACC Cardiovasc Interv. 2015 Jul;8(8):1009-1017. doi: 10.1016/j.jcin.2015.04.006. Epub 2015 Jun 24. PubMed 26117471 ↗
  • Papafaklis MI, Muramatsu T, Ishibashi Y, Lakkas LS, Nakatani S, Bourantas CV, Ligthart J, Onuma Y, Echavarria-Pinto M, Tsirka G, Kotsia A, Nikas DN, Mogabgab O, van Geuns RJ, Naka KK, Fotiadis DI, Brilakis ES, Garcia-Garcia HM, Escaned J, Zijlstra F, Michalis LK, Serruys PW. Fast virtual functional assessment of intermediate coronary lesions using routine angiographic data and blood flow simulation in humans: comparison with pressure wire - fractional flow reserve. EuroIntervention. 2014 Sep;10(5):574-83. doi: 10.4244/EIJY14M07_01. PubMed 24988003 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02998853
Lead sponsor
Azienda Ospedaliera Sant'Anna e San Sebastiano
Responsible party
dr. Domenico Di Girolamo (MD, Azienda Ospedaliera Sant'Anna e San Sebastiano) — Principal investigator
First posted
Dec 21, 2016
Start date
Nov 2016
Primary completion
Nov 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Dec 21, 2016

Study contacts

Domenico Di Girolamo, MD
Contact
mimmo.digirolamo@gmail.com
+390823232550
Giuseppe Mercone, MD
Contact
mimmo.digirolamo@gmail.com
+390823232550
Domenico Di Girolamo
principal investigator · Azienda Ospedaliera Sant'Anna e San Sebastiano
Giuseppe MERCONE, MD
principal investigator · Azienda Ospedaliera Sant'Anna e San Sebastiano

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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