<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/NCT03756870</url>
  </required_header>
  <id_info>
    <org_study_id>REVISE-CTO</org_study_id>
    <nct_id>NCT03756870</nct_id>
  </id_info>
  <brief_title>Revascularization Versus Optimal Medical Therapy of Chronic Total Coronary Occlusions on Left Ventricular Ischemia Reduction</brief_title>
  <acronym>REVISE-CTO</acronym>
  <official_title>REvascularization Versus Optimal Medical Therapy on Left Ventricular ISchemia Reduction: Exploring the Associations Between Ischemia, Functional Outcome and Collaterals in the Treatment of Chronic Total Occlusion Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Rationale: Randomized trials could not yet establish favourable outcomes of CTO PCI on hard&#xD;
      endpoints such as ejection fraction or mortality, when compared to optimal medical therapy.&#xD;
      However, patients after CTO PCI appeared to be more frequently free of angina complaints, but&#xD;
      the aetiology behind this is not fully understood. The investigators hypothesize that PCI of&#xD;
      the CTO in patients preselected with an ischemic threshold (&gt;12.5%) on cardiac imaging leads&#xD;
      to a reduction of the ischemic burden and therefore an increased benefit on functional&#xD;
      outcomes.&#xD;
&#xD;
      Objective: Primary objective is to determine whether PCI of the CTO will yield a higher&#xD;
      reduction of ischemia assessed by exercise myocardial perfusion SPECT-CT from baseline to&#xD;
      6-month follow-up compared to a control group. Secondary objectives are 1) to evaluate the&#xD;
      effect of PCI of the CTO on improvement in functional status, infarct size and left&#xD;
      ventricular function from baseline to follow-up compared to the control group; 2) to study&#xD;
      the association between ischemia reduction and functional outcome and left ventricular&#xD;
      function; 3) to assess the influence of the collateral flow index on the ischemic burden&#xD;
      (reduction), functional status, infarct size and left ventricular (contractile) function&#xD;
      (hibernation).&#xD;
&#xD;
      Study design: open multicentre randomized trial&#xD;
&#xD;
      Study population: 82 patients eligible for CTO PCI&#xD;
&#xD;
      Intervention: CTO PCI&#xD;
&#xD;
      Primary endpoint: ischemic burden assessed with exercise myocardial perfusion SPECT-CT from&#xD;
      baseline to 6 months follow-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2030</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>1:1 parallel design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ischemia</measure>
    <time_frame>6 months follow-up</time_frame>
    <description>Ischemic burden assessed with exercise myocardial perfusion SPECT-CT from baseline to 6 months follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in angina status assessed with the Seattle Angina Questionnaire.</measure>
    <time_frame>6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years</time_frame>
    <description>5 Seattle Angina Questionnaire subscales (0-100), higher scores indicating better angina status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessed with the Minnesota Living with Heart Failure Questionnaire (MLHFQ)</measure>
    <time_frame>6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years</time_frame>
    <description>MLHFQ scale (0-105), lower scores indicating better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The left ventricular ejection fraction assessed with cardiac magnetic resonance imaging</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">82</enrollment>
  <condition>Chronic Total Occlusion of Coronary Artery</condition>
  <arm_group>
    <arm_group_label>CTO PCI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive optimal medical therapy, with percutaneous coronary intervention of the chronic total occlusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OMT</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will receive optimal medical therapy, without percutaneous coronary intervention of the chronic total occlusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous coronary intervention (PCI)</intervention_name>
    <description>A percutaneous coronary intervention of the chronic total occlusion with a drug-eluting stent.</description>
    <arm_group_label>CTO PCI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. A chronic total occlusion is present and target lesion. A CTO is required to meet the&#xD;
             following characteristics:&#xD;
&#xD;
               -  A 100% luminal narrowing of the coronary artery without antegrade flow, i.e.&#xD;
                  Thrombolysis in Myocardial Infarction flow grade 0 or 1;&#xD;
&#xD;
               -  Older than 3 months, established with previous PCI or with angiographic&#xD;
                  characteristics;&#xD;
&#xD;
               -  Amenable to percutaneous revascularization.&#xD;
&#xD;
          2. Patient has a clinical indication to perform CTO PCI.&#xD;
&#xD;
          3. A SPECT is performed at baseline to assess ischemia and a cardiac magnetic resonance&#xD;
             imaging (CMR) scan to assess viability, as part of routine patient care. Patients are&#xD;
             deemed eligible for the randomized trial when they meet the ischemic threshold in the&#xD;
             CTO territory.&#xD;
&#xD;
             The ischemic threshold is defined as:&#xD;
&#xD;
               -  &gt;12.5% of ischemia;&#xD;
&#xD;
               -  With &lt;50% transmural extent of infarction.&#xD;
&#xD;
          4. Subject agrees to undergo follow-up SPECT-CT at 6 months after initial inclusion&#xD;
&#xD;
          5. Subject is able to verbally confirm understanding and he/she provides written informed&#xD;
             consent prior to any Clinical Investigation related procedure, as approved by the&#xD;
             appropriate Ethics Committee.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is younger than 18 years of age;&#xD;
&#xD;
          -  Persistent or permanent atrial fibrillation;&#xD;
&#xD;
          -  Presence of a non-MRI compatible cardiac device, i.e. pacemaker or implantable&#xD;
             cardioverter defibrillator;&#xD;
&#xD;
          -  Body weight &gt; 250 kg;&#xD;
&#xD;
          -  Unable to exert, i.e. due to physical disability;&#xD;
&#xD;
          -  Any contraindication for SPECT or CMR, i.e. cerebrovascular clips, claustrophobia;&#xD;
&#xD;
          -  Known renal insufficiency (estimated Glomerular Filtration Rate [eGFR] &lt;60&#xD;
             mL/min/1.73m2 or serum creatinine level of &gt;2.5 mg/dL or subject on dialysis);&#xD;
&#xD;
          -  Hypersensitivity or allergy to contrast with inability to properly pre-hydrate;&#xD;
&#xD;
          -  Presence of a comorbid condition with a life expectancy of less than one year;&#xD;
&#xD;
          -  Participation in another trial;&#xD;
&#xD;
          -  Subject is belonging to a vulnerable population (per investigator's judgment, e.g.,&#xD;
             subordinate hospital staff) or is unable to read or write.&#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_contact>
    <last_name>Prof. J.P.S. Henriques, MD PhD</last_name>
    <phone>+31205666405</phone>
    <email>j.p.henriques@amc.uva.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ms. A. van Veelen, MD</last_name>
    <phone>+31205666405</phone>
    <email>a.vanveelen@amc.uva.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Amsterdam UMC, location AMC</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anna van Veelen, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>July 19, 2023</last_update_submitted>
  <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
    <investigator_full_name>J.P.S Henriques</investigator_full_name>
    <investigator_title>Principal Investigator, Head of Catheterization Laboratory</investigator_title>
  </responsible_party>
  <keyword>Chronic total coronary occlusion</keyword>
  <keyword>Percutaneous coronary intervention</keyword>
  <keyword>Optimal medical therapy</keyword>
  <keyword>Myocardial ischemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Occlusion</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03756870
org study id: REVISE-CTO
nct id: NCT03756870
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Rationale: Randomized trials could not yet establish favourable outcomes of CTO PCI on hard
      endpoints such as ejection fraction or mortality, when compared to optimal medical therapy.
      However, patients after CTO PCI appeared to be more frequently free of angina complaints, but
      the aetiology behind this is not fully understood. The investigators hypothesize that PCI of
      the CTO in patients preselected with an ischemic threshold (>12.5%) on cardiac imaging leads
      to a reduction of the ischemic burden and therefore an increased benefit on functional
      outcomes.

      Objective: Primary objective is to determine whether PCI of the CTO will yield a higher
      reduction of ischemia assessed by exercise myocardial perfusion SPECT-CT from baseline to
      6-month follow-up compared to a control group. Secondary objectives are 1) to evaluate the
      effect of PCI of the CTO on improvement in functional status, infarct size and left
      ventricular function from baseline to follow-up compared to the control group; 2) to study
      the association between ischemia reduction and functional outcome and left ventricular
      function; 3) to assess the influence of the collateral flow index on the ischemic burden
      (reduction), functional status, infarct size and left ventricular (contractile) function
      (hibernation).

      Study design: open multicentre randomized trial

      Study population: 82 patients eligible for CTO PCI

      Intervention: CTO PCI

      Primary endpoint: ischemic burden assessed with exercise myocardial perfusion SPECT-CT from
      baseline to 6 months follow-up.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 1:1 parallel design
primary purpose: Treatment
masking: None (Open Label)
measure: Ischemia
time frame: 6 months follow-up
description: Ischemic burden assessed with exercise myocardial perfusion SPECT-CT from baseline to 6 months follow-up.
measure: Change in angina status assessed with the Seattle Angina Questionnaire.
time frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years
description: 5 Seattle Angina Questionnaire subscales (0-100), higher scores indicating better angina status.
measure: Quality of life assessed with the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
time frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years
description: MLHFQ scale (0-105), lower scores indicating better quality of life.
measure: The left ventricular ejection fraction assessed with cardiac magnetic resonance imaging
time frame: 6 months
arm group label: CTO PCI
arm group type: Experimental
description: Patients will receive optimal medical therapy, with percutaneous coronary intervention of the chronic total occlusion.
arm group label: OMT
arm group type: No Intervention
description: Patients will receive optimal medical therapy, without percutaneous coronary intervention of the chronic total occlusion.
intervention type: Procedure
intervention name: Percutaneous coronary intervention (PCI)
description: A percutaneous coronary intervention of the chronic total occlusion with a drug-eluting stent.
arm group label: CTO PCI
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Prof. J.P.S. Henriques, MD PhD
phone: +31205666405
email: j.p.henriques@amc.uva.nl
last name: Ms. A. van Veelen, MD
phone: +31205666405
email: a.vanveelen@amc.uva.nl
facility: 
status: Recruiting
contact: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: J.P.S Henriques
investigator title: Principal Investigator, Head of Catheterization Laboratory
mesh term: Coronary Occlusion
mesh term: Ischemia
sharing ipd: Undecided