<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/NCT04501549</url>
  </required_header>
  <id_info>
    <org_study_id>2018/2493</org_study_id>
    <nct_id>NCT04501549</nct_id>
  </id_info>
  <brief_title>Plaque mOrphology iMpact on Side Branch Occlusion at oPtical Coherence Tomography Evaluation in Percutaneous Coronary Interventions</brief_title>
  <acronym>POMPEI</acronym>
  <official_title>Plaque mOrphology iMpact on Side Branch Occlusion at oPtical Coherence Tomography Evaluation in Percutaneous Coronary Interventions: The POMPEI Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Heart Centre Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Heart Centre Singapore</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite recent advances in interventional cardiology, bifurcation coronary artery stenoses&#xD;
      (which account for 15-20% of all coronary lesions treated by PCI), remain a challenge for PCI&#xD;
      operators with higher rates of failure, in-stent restenosis, stent thrombosis, and recurrent&#xD;
      clinical events, when compared to simple non-bifurcation lesions.&#xD;
&#xD;
      POMPEI trial is a prospective observational study. We aim to investigate the impact of&#xD;
      morphological plaque characteristics assessed by optical coherence tomography (OCT) on the&#xD;
      risk of developing side branch occlusion (SBO) in bifurcation PCI.&#xD;
&#xD;
      A total of 27 patients undergoing bifurcation PCI will be recruited into the trial. PCI will&#xD;
      be performed according to local practice.The bifurcation lesion will be imaged by OCT on at&#xD;
      least two time-points for each patient. Plaque morphology will be characterized by OCT.&#xD;
      Off-line quantitative coronary angiography (QCA) will be performed before and after PCI and&#xD;
      the following QCA parameters will be computed: reference vessel diameter (RVD), lesion length&#xD;
      and diameter stenosis (DS) of Main Vessel (MV) and side branch (SB). Blood samples will be&#xD;
      taken prior to PCI and 8-12 hours later to determine peri-procedural myocardial injury and&#xD;
      infarction following PCI by measuring serum Troponin. The OCT data analysis will be performed&#xD;
      in collaboration with Dr Valeria Paradies who has been trained in interventional cardiology&#xD;
      in Rotterdam (The Netherlands) with specific interest in intravascular imaging.&#xD;
&#xD;
      In conclusion, we will use OCT to detect specific morphological characteristics which are&#xD;
      associated with acute SBO following main vessel stenting. The routine use of OCT during&#xD;
      bifurcation PCI to detect those patients at risk of acute SBO following main vessel stenting&#xD;
      will allow the PCI operator to implement measures for reducing the risk of SBO, thereby&#xD;
      minimizing the risk of peri- and post-PCI angina, preventing peri-procedural myocardial&#xD;
      injury and infarction, and improving clinical outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We hypothesized that in bifurcation lesion treatment, morphology of the plaque located in the&#xD;
      main vessel may impact on the risk of developing SBO.&#xD;
&#xD;
      The objectives of POMPEI study as follows:&#xD;
&#xD;
      Primary objective:&#xD;
&#xD;
      To identify correlation between lipid volume content of MV plaque and risk of SBO (TIMI&#xD;
      flow&lt;3)&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
      To identify the plaque morphology characteristics associated with SBO in patients undergoing&#xD;
      bifurcation PCI. OCT parameters which will be assessed include: distribution of lipid volume&#xD;
      and lipid arc in the MV and around SB ostium before and after stenting; prevalence of healed&#xD;
      plaque rupture and erosion and its correlation with SBO; correlation between calcium&#xD;
      distribution within the plaque and SBO; correlation between bifurcation angle and SBO; and&#xD;
      correlation between angiographic images of haziness at SB ostium and OCT findings.&#xD;
&#xD;
      To determine the prevalence of significant SB ostium stenosis in patients undergoing&#xD;
      bifurcation PCI.&#xD;
&#xD;
      To determine the incidences of SBO following bifurcation PCI.&#xD;
&#xD;
      To determine the incidence and extent of peri-procedural myocardial injury and infarction&#xD;
      following bifurcation PCI.&#xD;
&#xD;
      To determine correlation between SB lesion extension from the ostium and SBO&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 23, 2018</start_date>
  <completion_date type="Anticipated">April 14, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 14, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To undertake a proof-of-concept clinical study to investigate the impact of morphological plaque characteristics on the risk of developing SBO in bifurcation lesion treatment</measure>
    <time_frame>1year</time_frame>
    <description>If we can show that different culprit plaques behave differently, then there is the potential to undertake a larger study to change the way we manage these plaques and therapies to prevent SBO.</description>
  </primary_outcome>
  <enrollment type="Anticipated">27</enrollment>
  <condition>Bifurcation</condition>
  <condition>Percutaneous Coronary Intervention</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>percutaneous coronary intervention</intervention_name>
    <description>PCI will be performed according to local practice.The bifurcation lesion will be imaged by OCT on at least two time-points for each patient. Plaque morphology will be characterized by OCT. Off-line quantitative coronary angiography (QCA) will be performed before and after PCI and the following QCA parameters will be computed: reference vessel diameter (RVD), lesion length and diameter stenosis (DS) of Main Vessel (MV) and side branch (SB). Blood samples will be taken prior to PCI and 8-12 hours later to determine peri-procedural myocardial injury and infarction following PCI by measuring serum Troponin.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Outpatient waiting lists will be screened for patients undergoing election PCI for known&#xD;
        bifurcation lesions. Patients will also be recruited after the elective PCI procedure.&#xD;
        Patients who have undergone elective PCI for a bifurcation lesion which fits the criteria&#xD;
        below, and had OCT performed during the procedure for clinical reasons.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age≥21 years of age&#xD;
&#xD;
          -  Able to provide consent&#xD;
&#xD;
          -  At least one de-novo bifurcation lesion involving a side-branch (SB) ≥ 2mm and SB&#xD;
             ostial lesion ≥50% and &lt;90% by visual assessment intended to be treated by PCI with&#xD;
             provisional stenting strategy&#xD;
&#xD;
          -  TIMI flow 3 in both MV and SB&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous PCI of the target vessel&#xD;
&#xD;
          -  Cardiac arrest or cardiogenic shock&#xD;
&#xD;
          -  Left main or saphenous venous graft bifurcation&#xD;
&#xD;
          -  Significant renal impairment patients (eGFR&lt;30) who are not on dialysis&#xD;
&#xD;
          -  Inability to advance the OCT catheter or to obtain good image quality&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chin Chee Yang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Heart Centre Singapore</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>VANESSA WAN</last_name>
    <phone>+6567062273</phone>
    <email>vanessa.wan@nhcs.com.sg</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Heart Centre Singapore</name>
      <address>
        <city>Singapore</city>
        <zip>169609</zip>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanessa Wan</last_name>
      <phone>+6567042273</phone>
      <email>vanessa.wan@nhcs.com.sg</email>
    </contact>
    <investigator>
      <last_name>Chin Chee Yang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 2, 2020</study_first_submitted>
  <study_first_submitted_qc>August 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 2, 2020</last_update_submitted>
  <last_update_submitted_qc>August 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04501549
org study id: 2018/2493
nct id: NCT04501549
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Despite recent advances in interventional cardiology, bifurcation coronary artery stenoses
      (which account for 15-20% of all coronary lesions treated by PCI), remain a challenge for PCI
      operators with higher rates of failure, in-stent restenosis, stent thrombosis, and recurrent
      clinical events, when compared to simple non-bifurcation lesions.

      POMPEI trial is a prospective observational study. We aim to investigate the impact of
      morphological plaque characteristics assessed by optical coherence tomography (OCT) on the
      risk of developing side branch occlusion (SBO) in bifurcation PCI.

      A total of 27 patients undergoing bifurcation PCI will be recruited into the trial. PCI will
      be performed according to local practice.The bifurcation lesion will be imaged by OCT on at
      least two time-points for each patient. Plaque morphology will be characterized by OCT.
      Off-line quantitative coronary angiography (QCA) will be performed before and after PCI and
      the following QCA parameters will be computed: reference vessel diameter (RVD), lesion length
      and diameter stenosis (DS) of Main Vessel (MV) and side branch (SB). Blood samples will be
      taken prior to PCI and 8-12 hours later to determine peri-procedural myocardial injury and
      infarction following PCI by measuring serum Troponin. The OCT data analysis will be performed
      in collaboration with Dr Valeria Paradies who has been trained in interventional cardiology
      in Rotterdam (The Netherlands) with specific interest in intravascular imaging.

      In conclusion, we will use OCT to detect specific morphological characteristics which are
      associated with acute SBO following main vessel stenting. The routine use of OCT during
      bifurcation PCI to detect those patients at risk of acute SBO following main vessel stenting
      will allow the PCI operator to implement measures for reducing the risk of SBO, thereby
      minimizing the risk of peri- and post-PCI angina, preventing peri-procedural myocardial
      injury and infarction, and improving clinical outcomes.
We hypothesized that in bifurcation lesion treatment, morphology of the plaque located in the
      main vessel may impact on the risk of developing SBO.

      The objectives of POMPEI study as follows:

      Primary objective:

      To identify correlation between lipid volume content of MV plaque and risk of SBO (TIMI
      flow<3)

      Secondary objectives:

      To identify the plaque morphology characteristics associated with SBO in patients undergoing
      bifurcation PCI. OCT parameters which will be assessed include: distribution of lipid volume
      and lipid arc in the MV and around SB ostium before and after stenting; prevalence of healed
      plaque rupture and erosion and its correlation with SBO; correlation between calcium
      distribution within the plaque and SBO; correlation between bifurcation angle and SBO; and
      correlation between angiographic images of haziness at SB ostium and OCT findings.

      To determine the prevalence of significant SB ostium stenosis in patients undergoing
      bifurcation PCI.

      To determine the incidences of SBO following bifurcation PCI.

      To determine the incidence and extent of peri-procedural myocardial injury and infarction
      following bifurcation PCI.

      To determine correlation between SB lesion extension from the ostium and SBO
observational model: Case-Control
time perspective: Prospective
measure: To undertake a proof-of-concept clinical study to investigate the impact of morphological plaque characteristics on the risk of developing SBO in bifurcation lesion treatment
time frame: 1year
description: If we can show that different culprit plaques behave differently, then there is the potential to undertake a larger study to change the way we manage these plaques and therapies to prevent SBO.
intervention type: Procedure
intervention name: percutaneous coronary intervention
description: PCI will be performed according to local practice.The bifurcation lesion will be imaged by OCT on at least two time-points for each patient. Plaque morphology will be characterized by OCT. Off-line quantitative coronary angiography (QCA) will be performed before and after PCI and the following QCA parameters will be computed: reference vessel diameter (RVD), lesion length and diameter stenosis (DS) of Main Vessel (MV) and side branch (SB). Blood samples will be taken prior to PCI and 8-12 hours later to determine peri-procedural myocardial injury and infarction following PCI by measuring serum Troponin.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 99 Years
healthy volunteers: No
last name: Chin Chee Yang, MD
role: Principal Investigator
affiliation: National Heart Centre Singapore
last name: VANESSA WAN
phone: +6567062273
email: vanessa.wan@nhcs.com.sg
facility: 
status: Recruiting
contact: 
investigator: 
country: Singapore
responsible party type: Sponsor