<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/NCT01665833</url>
  </required_header>
  <id_info>
    <org_study_id>SYNTAX</org_study_id>
    <nct_id>NCT01665833</nct_id>
  </id_info>
  <brief_title>Impact of Coronary Anatomy on Angina Relief in Patients Undergoing Coronary Revascularization</brief_title>
  <official_title>A Retrospective Analysis Determining the Impact of Coronary Anatomy on Angina Relief in Patients Undergoing Coronary</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>North Texas Veterans Healthcare System</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>North Texas Veterans Healthcare System</source>
  <brief_summary>
    <textblock>
      We hypothesize that Coronary Artery Disease (CAD) severity assessed by SYNTAX score is an&#xD;
      independent predictor of recurrent or persistent angina following coronary revascularization.&#xD;
      The SYNTAX score is a score that suggests the severity of coronary artery disease detected by&#xD;
      coronary angiography. Coronary revascularization is a procedure that occurs in two ways, a&#xD;
      percutaneous coronary intervention (PCI) and a coronary artery bypass graft (CABG) and is&#xD;
      done when there is narrowing and blockage or hardening of the arteries (atherosclerosis)&#xD;
      surrounding the heart. Narrowing and blockages reduce blood flow to parts of the heart&#xD;
      causing chest pain (known as angina) and sometimes myocardial infarction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PCI and CABG are two well-established revascularization approaches to treatment of chronic&#xD;
      angina caused by coronary atherosclerosis. Nevertheless, 35-42% of patients report recurring&#xD;
      or persisting anginal symptoms after coronary revascularization. This can be attributed to&#xD;
      many structural and functional causes, prominent amongst which is pre-revascularization&#xD;
      angina severity, unrevascularized coronary territory, progression of native or bypass graft&#xD;
      atherosclerosis, restenosis (re-narrowing of the vessels) and accompanying adjunctive&#xD;
      pharmacotherapy.&#xD;
&#xD;
      The SYNTAX score is an angiographic tool for grading the complexity of coronary disease. It&#xD;
      is the sum of points assigned to coronary lesions within one of the 16 segments of the&#xD;
      coronary tree. The segments are given a 1,2, or 5 based on the disease presence as defined by&#xD;
      the American Heart Association classification. The SYNTAX score has been used to help predict&#xD;
      the outcomes of patients undergoing PCI with 3-vessel involvement (e.g. a triple bypass or&#xD;
      3-stent placement PCI). Those patients with the highest scores had the highest risk of a poor&#xD;
      outcome with PCI revascularization compared to CABG. Despite these observations, the impact&#xD;
      of CAD severity on post-revascularization angina, using the SYNTAX has never been&#xD;
      systematically addressed in the current era.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2003</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">December 2011</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hazard Rate</measure>
    <time_frame>1 year follow ups</time_frame>
    <description>Primary and secondary endpoints</description>
  </primary_outcome>
  <enrollment type="Actual">4000000</enrollment>
  <condition>Angina</condition>
  <condition>Status Post PCI</condition>
  <condition>Status Post CABG</condition>
  <eligibility>
    <study_pop>
      <textblock>
        We propose all patients between January 1, 2003 and December 31, 2011 who underwent an&#xD;
        uncomplicated coronary revascularization with PCI and/or CABG for chronic stable angina&#xD;
        within the VA. The data set that includes this information is the same as was used for&#xD;
        study 09-018 (VA-CAP Study).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any VA patient who has had an PCI from January 1, 2003 and December 31, 2011 and in&#xD;
             the database used in protocol 09-018 (VA-CAP Study).&#xD;
&#xD;
          -  Any VA patient who has received or will receive a 1-year follow up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Subhash Banerjee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dallas VA Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Emmanouil Brilakis, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dallas VA Medical Center</affiliation>
  </overall_official>
  <results_reference>
    <citation>Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Stahle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW; SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009 Mar 5;360(10):961-72. doi: 10.1056/NEJMoa0804626. Epub 2009 Feb 18. Erratum In: N Engl J Med. 2013 Feb 7;368(6):584.</citation>
    <PMID>19228612</PMID>
  </results_reference>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>August 13, 2012</last_update_submitted>
  <last_update_submitted_qc>August 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>North Texas Veterans Healthcare System</investigator_affiliation>
    <investigator_full_name>Subhash Banerjee</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Angina</keyword>
  <keyword>SYNTAX</keyword>
  <keyword>Coronary</keyword>
  <keyword>PCI</keyword>
  <keyword>CABG</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Angina Pectoris</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/NCT01665833
org study id: SYNTAX
nct id: NCT01665833
lead sponsor: 
We hypothesize that Coronary Artery Disease (CAD) severity assessed by SYNTAX score is an
      independent predictor of recurrent or persistent angina following coronary revascularization.
      The SYNTAX score is a score that suggests the severity of coronary artery disease detected by
      coronary angiography. Coronary revascularization is a procedure that occurs in two ways, a
      percutaneous coronary intervention (PCI) and a coronary artery bypass graft (CABG) and is
      done when there is narrowing and blockage or hardening of the arteries (atherosclerosis)
      surrounding the heart. Narrowing and blockages reduce blood flow to parts of the heart
      causing chest pain (known as angina) and sometimes myocardial infarction.
PCI and CABG are two well-established revascularization approaches to treatment of chronic
      angina caused by coronary atherosclerosis. Nevertheless, 35-42% of patients report recurring
      or persisting anginal symptoms after coronary revascularization. This can be attributed to
      many structural and functional causes, prominent amongst which is pre-revascularization
      angina severity, unrevascularized coronary territory, progression of native or bypass graft
      atherosclerosis, restenosis (re-narrowing of the vessels) and accompanying adjunctive
      pharmacotherapy.

      The SYNTAX score is an angiographic tool for grading the complexity of coronary disease. It
      is the sum of points assigned to coronary lesions within one of the 16 segments of the
      coronary tree. The segments are given a 1,2, or 5 based on the disease presence as defined by
      the American Heart Association classification. The SYNTAX score has been used to help predict
      the outcomes of patients undergoing PCI with 3-vessel involvement (e.g. a triple bypass or
      3-stent placement PCI). Those patients with the highest scores had the highest risk of a poor
      outcome with PCI revascularization compared to CABG. Despite these observations, the impact
      of CAD severity on post-revascularization angina, using the SYNTAX has never been
      systematically addressed in the current era.
time perspective: Retrospective
measure: Hazard Rate
time frame: 1 year follow ups
description: Primary and secondary endpoints
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Subhash Banerjee, MD
role: Principal Investigator
affiliation: Dallas VA Medical Center
last name: Emmanouil Brilakis, MD,PhD
role: Principal Investigator
affiliation: Dallas VA Medical Center
citation: Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Stahle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW; SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009 Mar 5;360(10):961-72. doi: 10.1056/NEJMoa0804626. Epub 2009 Feb 18. Erratum In: N Engl J Med. 2013 Feb 7;368(6):584.
PMID: 19228612
responsible party type: Principal Investigator
investigator affiliation: North Texas Veterans Healthcare System
investigator full name: Subhash Banerjee
investigator title: MD
mesh term: Angina Pectoris