<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/NCT04465526</url>
  </required_header>
  <id_info>
    <org_study_id>2.31/III/2020</org_study_id>
    <nct_id>NCT04465526</nct_id>
  </id_info>
  <brief_title>The Influence of Coronary Chronic Total Occlusion on Myocardial Perfusion on Computed Tomography</brief_title>
  <acronym>COPACABANA</acronym>
  <official_title>The Influence of Coronary Chronic Total Occlusion on Myocardial Perfusion on Dual-energy Computed Tomography (COPACABANA Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Cardiology, Warsaw, Poland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institute of Cardiology, Warsaw, Poland</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The COPACABANA study is designed as a single-centre, open, prospective trial aimed to assess&#xD;
      the influence of coronary chronic total occlusion (CTO) on downstream myocardial ischemia via&#xD;
      the novel computed tomography perfusion (CTP) imaging technique. To this end, consecutive&#xD;
      patients with CTO of a major coronary artery scheduled to undergo percutaneous recanalization&#xD;
      of occluded coronary artery based on clinical grounds, will undergo stress CTP using&#xD;
      state-of-the-art dual-energy CT scanner at 2 time points (before and 3 months after&#xD;
      successful restoration of flow in the CTO vessel).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2022</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>Feasibility of stress computed tomography perfusion imaging for myocardial ischemia assessment in patients with a coronary chronic total occlusion</measure>
    <time_frame>1 day</time_frame>
    <description>Feasibility of a fast, reliable and safe evaluation of myocardial ischemia in patients with CTO using state-of-the-art computed tomography scanner (SOMATOM® Force) with a dual-energy stress myocardial perfusion imaging protocol in order to obtain in-depth knowledge of the underlying conditions and characteristics of this phenomenon.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of myocardial ischemia using stress computed tomography perfusion imaging in patients with a coronary chronic total occlusion</measure>
    <time_frame>1 day</time_frame>
    <description>Qualitative and quantitative assessment of myocardial ischemia using stress computed tomography perfusion imaging in patients with a coronary chronic total occlusion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in myocardial perfusion between baseline (pre-procedural) and follow-up (post-procedural) stress computed tomography perfusion study after successful recanalization of the chronically occluded coronary artery</measure>
    <time_frame>1 day and 3 months</time_frame>
    <description>Qualitative and quantitative assessment of the change in myocardial perfusion between baseline (pre-procedural) and follow-up (post-procedural) stress computed tomography perfusion study after successful recanalization of the chronically occluded coronary artery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiation dose associated with computed tomography perfusion study in patients with a coronary chronic total occlusion</measure>
    <time_frame>1 day and 3 months</time_frame>
    <description>Radiation dose associated with computed tomography perfusion study in patients with a coronary chronic total occlusion undergoing percutaneous recanalization attempt.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contrast volume associated with computed tomography perfusion study in patients with a coronary chronic total occlusion</measure>
    <time_frame>1 day and 3 months</time_frame>
    <description>Contrast volume associated with computed tomography perfusion study in patients with a coronary chronic total occlusion undergoing percutaneous recanalization attempt.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Coronary Occlusion</condition>
  <condition>Myocardial Ischemia</condition>
  <condition>Myocardial Perfusion Imaging</condition>
  <condition>Percutaneous Coronary Intervention</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>computed tomography perfusion imaging</intervention_name>
    <description>The new-generation dual-source computed tomography scanner Somatom® Force will be used for all CTP studies. Myocardial perfusion will be evaluated in a stress dynamic CT protocol. The scan range will be determined based on a low-dose non-contrast scan. Subsequently, regadenoson will be administered intravenously at a single dose of 0.4 mg, and followed after 50 seconds delay by 35 mL of the iodinated contrast agent (iohexol, concentration 350 mg I/mL) injected at the flow rate of 5 mL/s. Finally, low-dose non-contrast dual-energy CT scan will be performed 5-6 min after the dynamic scan to assess late enhancement of the myocardium.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We intend to include 30 consecutive patients with chronic total occlusion of a major&#xD;
        coronary artery and preserved left ventricular ejection fraction (&gt;50%) referred for&#xD;
        percutaneous recanalization attempt based on clinical grounds.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  delivery of an informed consent and compliance with study protocol&#xD;
&#xD;
          -  persistent angina pectoris (CCS class ≥2) refractory to optimal medical therapy&#xD;
&#xD;
          -  CTO of a major coronary artery (left anterior descending artery, right coronary&#xD;
             artery, left circumflex artery) of at least 2.5 mm vessel diameter confirmed by&#xD;
             invasive angiography&#xD;
&#xD;
          -  preserved left ventricular ejection fraction (&gt;50%) on echocardiography or cardiac&#xD;
             magnetic resonance with preserved contractility in the CTO territory (normokinesia&#xD;
             and/or hypokinesia)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unstable angina and/or myocardial infarction&#xD;
&#xD;
          -  prior myocardial infarction within 4 weeks before study enrolment&#xD;
&#xD;
          -  occurrence of myocardial infarction and/or unplanned revascularization between the&#xD;
             index procedure and post-procedural CTP study&#xD;
&#xD;
          -  impaired renal function (eGFR ≤45 ml/min/m2)&#xD;
&#xD;
          -  contraindications to antiplatelet therapy and/or heparin&#xD;
&#xD;
          -  other contraindications to CTP (pregnancy, allergy to contrast media or pharmacologic&#xD;
             stress agents, tachyarrhythmia, claustrophobia)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National Institute of Cardiology</name>
      <address>
        <city>Warsaw</city>
        <zip>04-628</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maksymilian P. Opolski, MD, PhD</last_name>
      <phone>+48501444303</phone>
      <email>mopolski@ikard.pl</email>
    </contact>
    <contact_backup>
      <last_name>Jacek Kwiecinski, MD, PhD</last_name>
      <phone>+48223434127</phone>
      <email>jkwiecinski@ikard.pl</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Occlusion</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04465526
org study id: 2.31/III/2020
nct id: NCT04465526
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The COPACABANA study is designed as a single-centre, open, prospective trial aimed to assess
      the influence of coronary chronic total occlusion (CTO) on downstream myocardial ischemia via
      the novel computed tomography perfusion (CTP) imaging technique. To this end, consecutive
      patients with CTO of a major coronary artery scheduled to undergo percutaneous recanalization
      of occluded coronary artery based on clinical grounds, will undergo stress CTP using
      state-of-the-art dual-energy CT scanner at 2 time points (before and 3 months after
      successful restoration of flow in the CTO vessel).
observational model: Cohort
time perspective: Prospective
measure: Feasibility of stress computed tomography perfusion imaging for myocardial ischemia assessment in patients with a coronary chronic total occlusion
time frame: 1 day
description: Feasibility of a fast, reliable and safe evaluation of myocardial ischemia in patients with CTO using state-of-the-art computed tomography scanner (SOMATOM® Force) with a dual-energy stress myocardial perfusion imaging protocol in order to obtain in-depth knowledge of the underlying conditions and characteristics of this phenomenon.
measure: Evaluation of myocardial ischemia using stress computed tomography perfusion imaging in patients with a coronary chronic total occlusion
time frame: 1 day
description: Qualitative and quantitative assessment of myocardial ischemia using stress computed tomography perfusion imaging in patients with a coronary chronic total occlusion.
measure: Change in myocardial perfusion between baseline (pre-procedural) and follow-up (post-procedural) stress computed tomography perfusion study after successful recanalization of the chronically occluded coronary artery
time frame: 1 day and 3 months
description: Qualitative and quantitative assessment of the change in myocardial perfusion between baseline (pre-procedural) and follow-up (post-procedural) stress computed tomography perfusion study after successful recanalization of the chronically occluded coronary artery.
measure: Radiation dose associated with computed tomography perfusion study in patients with a coronary chronic total occlusion
time frame: 1 day and 3 months
description: Radiation dose associated with computed tomography perfusion study in patients with a coronary chronic total occlusion undergoing percutaneous recanalization attempt.
measure: Contrast volume associated with computed tomography perfusion study in patients with a coronary chronic total occlusion
time frame: 1 day and 3 months
description: Contrast volume associated with computed tomography perfusion study in patients with a coronary chronic total occlusion undergoing percutaneous recanalization attempt.
intervention type: Diagnostic Test
intervention name: computed tomography perfusion imaging
description: The new-generation dual-source computed tomography scanner Somatom® Force will be used for all CTP studies. Myocardial perfusion will be evaluated in a stress dynamic CT protocol. The scan range will be determined based on a low-dose non-contrast scan. Subsequently, regadenoson will be administered intravenously at a single dose of 0.4 mg, and followed after 50 seconds delay by 35 mL of the iodinated contrast agent (iohexol, concentration 350 mg I/mL) injected at the flow rate of 5 mL/s. Finally, low-dose non-contrast dual-energy CT scan will be performed 5-6 min after the dynamic scan to assess late enhancement of the myocardium.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
country: Poland
responsible party type: Sponsor
mesh term: Myocardial Ischemia
mesh term: Coronary Occlusion
mesh term: Ischemia
sharing ipd: No