<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02998853</url>
  </required_header>
  <id_info>
    <org_study_id>AOStAnnaSS</org_study_id>
    <nct_id>NCT02998853</nct_id>
  </id_info>
  <brief_title>Non Culprit Functional Evaluation With 3D Angio QFR in STEMI PCI Procedure</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliera Sant'Anna e San Sebastiano</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Ospedaliera Sant'Anna e San Sebastiano</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Reliability of 3D angio QFR functional evaluation of all non culprit lesions &gt;50% in STEMI&#xD;
      patients during first acute procedure&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      3DAngio QFR is an angiographic based tool for coronary stenosis functional assessment: it is&#xD;
      validated versus Adenosine FFR(ADOFFR) by several studies (FAVOR, VIRTU-1) ; in particular&#xD;
      post contrast QFR (cQFR) showed a very good correlation with ADOFFR. Furthermore ADOFFR in&#xD;
      non culprit vessel in acute stage of STEMI correlates well with ADOFFR of the same non&#xD;
      culprit lesion in staged procedure. Aim of the study is to find a valid correlation between&#xD;
      cQFR in acute study and ADOFFR in the staged procedure. A positive result may lead to a fast,&#xD;
      easy and cost effective acute functional non culprit lesions evaluation during acute&#xD;
      procedure for STEMI patients, selecting those,if any, to be treated immediately or in a&#xD;
      staged procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">November 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <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</measure>
    <time_frame>1 - 15 days</time_frame>
    <description>Diagnostic performance of QFR in comparison to FFR reported as positive and negative likelihood ratio</description>
  </primary_outcome>
  <secondary_outcome>
    <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</measure>
    <time_frame>0-15 days</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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic accuracy of TIMI flow based for computing QFR in staged study in comparison with Hyperemic FFR in the same lesion</measure>
    <time_frame>0-1 hour</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</description>
  </secondary_outcome>
  <enrollment type="Anticipated">120</enrollment>
  <condition>STEMI - ST Elevation Myocardial Infarction</condition>
  <condition>Percutaneous Coronary Intervention</condition>
  <condition>Coronary Artery Disease</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>QFR measurement by dedicated workstation on xrays angio selected runs</intervention_name>
    <description>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</description>
    <other_name>3d Angio QFR evaluation</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive STEMI patients with at least one non culprit artery with stenosis &gt;50%.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  STEMI/NSTEMI pts with at least 1 non culprit lesion &gt; 50%&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Able to provide signed informed consent&#xD;
&#xD;
          -  Angiographic inclusion criteria:&#xD;
&#xD;
          -  Indication for FFR in at least one stenosis:&#xD;
&#xD;
          -  Diameter stenosis of 50%-90% by visual estimate&#xD;
&#xD;
          -  Reference vessel size &gt; 2 mm in stenotic segment by visual estimate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe asthma or severe chronic obstructive pulmonary disease&#xD;
&#xD;
          -  Severe heart failure (NYHA≥III)&#xD;
&#xD;
          -  S-creatinine&gt;150µmol/L or GFR&lt;45 ml/kg/1.73m2&#xD;
&#xD;
          -  Allergy to contrast media or adenosine&#xD;
&#xD;
          -  Atrial fibrillation&#xD;
&#xD;
        Angiographic exclusion criteria:&#xD;
&#xD;
        poor coronary opacification marked overlapping marked tortuosity angio acquisition protocol&#xD;
        incomplete&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Domenico Di Girolamo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliera Sant'Anna e San Sebastiano</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Giuseppe MERCONE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliera Sant'Anna e San Sebastiano</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Domenico Di Girolamo, MD</last_name>
    <phone>+390823232550</phone>
    <email>mimmo.digirolamo@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Giuseppe Mercone, MD</last_name>
    <phone>+390823232550</phone>
    <email>mimmo.digirolamo@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Azienda Ospedaliera Sant-Anna e San Sebastiano</name>
      <address>
        <city>Caserta</city>
        <zip>81100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giuseppe Mercone, MD</last_name>
      <phone>+390823232550</phone>
      <email>mimmo.digirolamo@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Alfonso Alfieri, MD</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>27712739</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>27867288</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>27743953</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>25464218</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>26055262</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>26347918</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>23428006</PMID>
  </results_reference>
  <results_reference>
    <citation>Morris PD, van de Vosse FN, Lawford PV, Hose DR, Gunn JP. &quot;Virtual&quot; (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.</citation>
    <PMID>26117471</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>24988003</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>December 16, 2016</last_update_submitted>
  <last_update_submitted_qc>December 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliera Sant'Anna e San Sebastiano</investigator_affiliation>
    <investigator_full_name>dr. Domenico Di Girolamo</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Non culprit</keyword>
  <keyword>STEMI PCI</keyword>
  <keyword>angio QFR</keyword>
  <keyword>FFR</keyword>
  <keyword>Staged procedure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02998853
org study id: AOStAnnaSS
nct id: NCT02998853
lead sponsor: 
has dmc: No
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.
observational model: Cohort
time perspective: Prospective
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
description: Diagnostic performance of QFR in comparison to FFR reported as positive and negative likelihood ratio
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
time frame: 0-15 days
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
measure: Diagnostic accuracy of TIMI flow based for computing QFR in staged study in comparison with Hyperemic FFR in the same lesion
time frame: 0-1 hour
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
intervention type: Other
intervention name: QFR measurement by dedicated workstation on xrays angio selected runs
description: 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
other name: 3d Angio QFR evaluation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Domenico Di Girolamo
role: Principal Investigator
affiliation: Azienda Ospedaliera Sant'Anna e San Sebastiano
last name: Giuseppe MERCONE, MD
role: Principal Investigator
affiliation: Azienda Ospedaliera Sant'Anna e San Sebastiano
last name: Domenico Di Girolamo, MD
phone: +390823232550
email: mimmo.digirolamo@gmail.com
last name: Giuseppe Mercone, MD
phone: +390823232550
email: mimmo.digirolamo@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Italy
citation: 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.
PMID: 27712739
citation: 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.
PMID: 27867288
citation: 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.
PMID: 27743953
citation: 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.
PMID: 25464218
citation: 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.
PMID: 26055262
citation: 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.
PMID: 26347918
citation: 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.
PMID: 23428006
citation: 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.
PMID: 26117471
citation: 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.
PMID: 24988003
responsible party type: Principal Investigator
investigator affiliation: Azienda Ospedaliera Sant'Anna e San Sebastiano
investigator full name: dr. Domenico Di Girolamo
investigator title: MD
mesh term: Coronary Artery Disease
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction