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STEMI - ST Elevation Myocardial InfarctionNCT02998853

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

An observational study of STEMI - ST Elevation Myocardial Infarction and Percutaneous Coronary Intervention, run by Azienda Ospedaliera Sant'Anna e San Sebastiano at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 85 years
What is being tested?
QFR measurement by dedicated workstation on xrays angio selected runs
How many people
120 participants
Where
1 siteItaly
Study dates
Nov 2016to Dec 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Domenico Di Girolamo, MD contact

+390823232550

mimmo.digirolamo@gmail.com

Giuseppe Mercone, MD contact

+390823232550

mimmo.digirolamo@gmail.com

Italy1 site, 1 recruiting

  • Azienda Ospedaliera Sant-Anna e San Sebastiano

    Caserta, Caserta, 81100

    Giuseppe Mercone, MD, +390823232550, mimmo.digirolamo@gmail.com

    Alfonso Alfieri, MD

    Recruiting

Other trials in Italy

About this study

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

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.

Being tested
QFR measurement by dedicated workstation on xrays angio selected runs
Keywords
Non culprit, STEMI PCI, angio QFR, FFR, Staged procedure
Medical subject headings
ST Elevation Myocardial Infarction, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QFR measurement by dedicated workstation on xrays angio selected runsOther

    Also called 3d Angio QFR evaluation

    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 being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 - 15 days

Secondary outcomes (2)

  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

    Measured: 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

    Measured: 0-1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionNov 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02998853
Sponsor's protocol ID
AOStAnnaSS
Status last verified
Dec 2016
First submitted
13 Dec 2016
Last updated
21 Dec 2016
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of STEMI - ST Elevation Myocardial Infarction and Percutaneous Coronary Intervention, run by Azienda Ospedaliera Sant'Anna e San Sebastiano at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Domenico Di Girolamo, MD (+390823232550, mimmo.digirolamo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 1 - 15 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02998853, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2016; AzTrials last refreshed its copy on 31 Oct 2026.

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