<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/NCT03830853</url>
  </required_header>
  <id_info>
    <org_study_id>240138</org_study_id>
    <nct_id>NCT03830853</nct_id>
  </id_info>
  <brief_title>The Impact of Coronary Chronic Total Occlusion Percutaneous Coronary Intervention on Culprit Vessel Physiology</brief_title>
  <acronym>IMPACT-CTO-2</acronym>
  <official_title>The Impact of Coronary Chronic Total Occlusion Percutaneous Coronary Intervention on Culprit Vessel Physiology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mid and South Essex NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Brighton and Sussex University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mid and South Essex NHS Foundation Trust</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>
      Following successful CTO PCI, a multitude of physiological and anatomical changes take place.&#xD;
      Contemporary techniques such as dissection/re-entry or lumen-lumen wiring may influence the&#xD;
      immediate and longer term follow up of these features. It is not known whether changes in&#xD;
      this level of physiology and anatomy in the context of CTO vessels correlate with each other,&#xD;
      or with quality of life and exercise capacity.&#xD;
&#xD;
      This study aims to take physiological measurements of absolute coronary flow, resistance and&#xD;
      pressure and intra-coronary imaging immediately after successful CTO PCI. The investigators&#xD;
      will relate these to each other and to the method of revascularisation, comparing changes in&#xD;
      these groups at three months follow up.&#xD;
&#xD;
      QoL measurements, and exercise testing will be carried out to see if there is a relationship&#xD;
      between physiological and anatomical changes with exercise capacity and quality of life.&#xD;
&#xD;
      Results from this study could shed light on optimisation of CTO PCI procedural and clinical&#xD;
      outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Following successful chronic total occlusion (CTO) percutaneous coronary intervention (PCI),&#xD;
      a multitude of physiological and anatomical changes take place. Contemporary techniques such&#xD;
      as dissection/re-entry or lumen-lumen wiring may influence the immediate and longer term&#xD;
      follow up of these features. It is not known whether changes in this level of physiology and&#xD;
      anatomy in the context of CTO vessels correlate with each other, or with quality of life and&#xD;
      exercise capacity.&#xD;
&#xD;
      This study aims to take physiological measurements of absolute coronary flow, resistance and&#xD;
      pressure and intra-coronary imaging immediately after successful CTO PCI. The investigators&#xD;
      will relate these to each other and to the method of revascularisation, comparing changes in&#xD;
      these groups at three months follow up.&#xD;
&#xD;
      Quality of life measurements, and exercise testing will be carried out to see if there is a&#xD;
      relationship between physiological and anatomical changes with exercise capacity and quality&#xD;
      of life.&#xD;
&#xD;
      Results from this study could shed light on optimisation of CTO PCI procedural and clinical&#xD;
      outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 23, 2015</start_date>
  <completion_date type="Actual">January 1, 2018</completion_date>
  <primary_completion_date type="Actual">January 1, 2018</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>Change in coronary flow</measure>
    <time_frame>3 months</time_frame>
    <description>change in coronary flow at baseline and follow up</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in coronary resistance</measure>
    <time_frame>3 months</time_frame>
    <description>change in coronary absolute resistance at baseline and follow up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in coronary anatomy</measure>
    <time_frame>3 months</time_frame>
    <description>To identify intracoronary anatomical features between baseline and follow up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in exercise work load</measure>
    <time_frame>3 months</time_frame>
    <description>Change in exercise work measured in METS (metabolic equivalents).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>3 months</time_frame>
    <description>change in quality measured by the validated Seattle angina seven question questionnaire from baseline to follow up. This is a scale based on 7 questions giving scores of 0-100 on physical limitation, angina, and quality of life, with the average of these scores giving a mean value also ranging from 0-100 of the overall summary score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in coronary pressure measurements</measure>
    <time_frame>3 months</time_frame>
    <description>change in fractional flow reserve (FFR) at baseline and follow up</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Chronic Total Occlusion of Coronary Artery</condition>
  <arm_group>
    <arm_group_label>Successful CTO PCI achieved</arm_group_label>
    <description>Patients will have successful CTO PCI (chronic total occlusion percutaneous coronary intervention) followed by physiological and intracoronary imaging. These measurements will be repeated at a 3 month follow up angiogram procedure.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have been selected for elective percutaneous coronary angioplasty (PCI) of&#xD;
        their chronic total occlusion (CTO) as part of routine standard of care will be approached&#xD;
        for the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age&#xD;
&#xD;
          -  Presence of a coronary chronic total occlusion (CTO) scheduled for elective&#xD;
             percutaneous coronary angioplasty (PCI)&#xD;
&#xD;
          -  Evidence of viability in the CTO Territory&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 18 year of age&#xD;
&#xD;
          -  Unable to give informed consent&#xD;
&#xD;
          -  Known severe chronic kidney disease (creatinine clearance ≤30 mL/min), unless the&#xD;
             patient is on dialysis&#xD;
&#xD;
          -  Unable to receive antiplatelets or periprocedural anticoagulation&#xD;
&#xD;
          -  Contraindications to adenosine&#xD;
&#xD;
          -  Any study lesion characteristic resulting in the expected inability to deliver FD-OCT&#xD;
             catheter at the distal vessel post CTO PCI (e.g. moderate or severe vessel&#xD;
             calcification or tortuosity)&#xD;
&#xD;
          -  Pregnancy, planning pregnancy during study period, or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Davies, MBBS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Basildon and Thurrock University Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Essex Cardiothoracic Centre</name>
      <address>
        <city>Basildon</city>
        <state>Essex</state>
        <zip>S16 5NL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>December 20, 2021</last_update_submitted>
  <last_update_submitted_qc>December 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CTO - chronic total occlusion</keyword>
  <keyword>OCT - optical coherence tomography</keyword>
  <keyword>coronary physiology</keyword>
  <keyword>absolute flow</keyword>
  <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/NCT03830853
org study id: 240138
nct id: NCT03830853
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Following successful CTO PCI, a multitude of physiological and anatomical changes take place.
      Contemporary techniques such as dissection/re-entry or lumen-lumen wiring may influence the
      immediate and longer term follow up of these features. It is not known whether changes in
      this level of physiology and anatomy in the context of CTO vessels correlate with each other,
      or with quality of life and exercise capacity.

      This study aims to take physiological measurements of absolute coronary flow, resistance and
      pressure and intra-coronary imaging immediately after successful CTO PCI. The investigators
      will relate these to each other and to the method of revascularisation, comparing changes in
      these groups at three months follow up.

      QoL measurements, and exercise testing will be carried out to see if there is a relationship
      between physiological and anatomical changes with exercise capacity and quality of life.

      Results from this study could shed light on optimisation of CTO PCI procedural and clinical
      outcomes.
Following successful chronic total occlusion (CTO) percutaneous coronary intervention (PCI),
      a multitude of physiological and anatomical changes take place. Contemporary techniques such
      as dissection/re-entry or lumen-lumen wiring may influence the immediate and longer term
      follow up of these features. It is not known whether changes in this level of physiology and
      anatomy in the context of CTO vessels correlate with each other, or with quality of life and
      exercise capacity.

      This study aims to take physiological measurements of absolute coronary flow, resistance and
      pressure and intra-coronary imaging immediately after successful CTO PCI. The investigators
      will relate these to each other and to the method of revascularisation, comparing changes in
      these groups at three months follow up.

      Quality of life measurements, and exercise testing will be carried out to see if there is a
      relationship between physiological and anatomical changes with exercise capacity and quality
      of life.

      Results from this study could shed light on optimisation of CTO PCI procedural and clinical
      outcomes.
observational model: Cohort
time perspective: Prospective
measure: Change in coronary flow
time frame: 3 months
description: change in coronary flow at baseline and follow up
measure: Change in coronary resistance
time frame: 3 months
description: change in coronary absolute resistance at baseline and follow up
measure: Change in coronary anatomy
time frame: 3 months
description: To identify intracoronary anatomical features between baseline and follow up.
measure: Change in exercise work load
time frame: 3 months
description: Change in exercise work measured in METS (metabolic equivalents).
measure: Change in quality of life
time frame: 3 months
description: change in quality measured by the validated Seattle angina seven question questionnaire from baseline to follow up. This is a scale based on 7 questions giving scores of 0-100 on physical limitation, angina, and quality of life, with the average of these scores giving a mean value also ranging from 0-100 of the overall summary score.
measure: Change in coronary pressure measurements
time frame: 3 months
description: change in fractional flow reserve (FFR) at baseline and follow up
arm group label: Successful CTO PCI achieved
description: Patients will have successful CTO PCI (chronic total occlusion percutaneous coronary intervention) followed by physiological and intracoronary imaging. These measurements will be repeated at a 3 month follow up angiogram procedure.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John Davies, MBBS, PhD
role: Principal Investigator
affiliation: Basildon and Thurrock University Hospitals
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No