<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/NCT02255123</url>
  </required_header>
  <id_info>
    <org_study_id>DAIT CTOT-18</org_study_id>
    <nct_id>NCT02255123</nct_id>
  </id_info>
  <brief_title>Retrospective Multicenter Study to Determine 4-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-05 Study</brief_title>
  <official_title>A Retrospective Multicenter Study to Determine 4-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-05 Study (CTOT-18)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institute of Allergy and Infectious Diseases (NIAID)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a multicenter, non-randomized, retrospective study to collect long term (4&#xD;
      years post-transplant) clinical outcome data on subjects previously enrolled in the CTOT-05&#xD;
      study (NCT00466804) to evaluate participant and graft survival.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Composite incidence of Death, Re-transplantation or re-listed for transplantation, Coronary stent, Myocardial Infarction and Clinical evidence of CAV per ISHLT grading</measure>
    <time_frame>48 months (+/- 6 months) after primary transplantation</time_frame>
    <description>Coronary Artery Vasculopathy (CAV)&#xD;
International Society for Heart and Lung Transplantation Registry (ISHLT)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of death</measure>
    <time_frame>48 months (+/- 6 months) after primary transplantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of re-transplantation or re-listed for transplantation</measure>
    <time_frame>48 months (+/- 6 months) after primary transplantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of coronary stent</measure>
    <time_frame>48 months (+/- 6 months) after primary transplantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of myocardial infarction</measure>
    <time_frame>48 months (+/- 6 months) after primary transplantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinical evidence of CAV per ISHLT grading</measure>
    <time_frame>48 months (+/- 6 months) after primary transplantation</time_frame>
    <description>Coronary Artery Vasculopathy (CAV)&#xD;
International Society for Heart and Lung Transplantation Registry (ISHLT)</description>
  </secondary_outcome>
  <enrollment type="Actual">178</enrollment>
  <condition>Cardiac Transplantation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study population was selected based on their previous participation in the parent study&#xD;
        (CTOT-05). Participants enrolled in this study are at least 4 years post-transplant as of&#xD;
        July 2014.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects previously enrolled in the CTOT-05 study&#xD;
&#xD;
          2. Subjects 4 years post-transplant (+/- 6 months).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Withdrawal of consent from the CTOT-05 study.&#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>Peter S Heeger, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anil K. Chandraker, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California at San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loyola University Medical</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham &amp; Womens Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newark Beth Israel Medical Center</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical City Dallas Hospital/ CRSTI</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intermountain Medical Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.niaid.nih.gov</url>
    <description>The National Institute of Allergy and Infectious Diseases (NIAID)</description>
  </link>
  <link>
    <url>https://www.ctotstudies.org/</url>
    <description>Clinical Trials in Organ Transplantation (CTOT)</description>
  </link>
  <reference>
    <citation>Starling RC, Stehlik J, Baran DA, Armstrong B, Stone JR, Ikle D, Morrison Y, Bridges ND, Putheti P, Strom TB, Bhasin M, Guleria I, Chandraker A, Sayegh M, Daly KP, Briscoe DM, Heeger PS; CTOT-05 consortium. Multicenter Analysis of Immune Biomarkers and Heart Transplant Outcomes: Results of the Clinical Trials in Organ Transplantation-05 Study. Am J Transplant. 2016 Jan;16(1):121-36. doi: 10.1111/ajt.13422. Epub 2015 Aug 10.</citation>
    <PMID>26260101</PMID>
  </reference>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>March 22, 2016</last_update_submitted>
  <last_update_submitted_qc>March 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 23, 2016</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/NCT02255123
org study id: DAIT CTOT-18
nct id: NCT02255123
lead sponsor: 
has dmc: No
This study is a multicenter, non-randomized, retrospective study to collect long term (4
      years post-transplant) clinical outcome data on subjects previously enrolled in the CTOT-05
      study (NCT00466804) to evaluate participant and graft survival.
observational model: Case-Only
time perspective: Retrospective
measure: Composite incidence of Death, Re-transplantation or re-listed for transplantation, Coronary stent, Myocardial Infarction and Clinical evidence of CAV per ISHLT grading
time frame: 48 months (+/- 6 months) after primary transplantation
description: Coronary Artery Vasculopathy (CAV)
International Society for Heart and Lung Transplantation Registry (ISHLT)
measure: Incidence of death
time frame: 48 months (+/- 6 months) after primary transplantation
measure: Incidence of re-transplantation or re-listed for transplantation
time frame: 48 months (+/- 6 months) after primary transplantation
measure: Incidence of coronary stent
time frame: 48 months (+/- 6 months) after primary transplantation
measure: Incidence of myocardial infarction
time frame: 48 months (+/- 6 months) after primary transplantation
measure: Incidence of clinical evidence of CAV per ISHLT grading
time frame: 48 months (+/- 6 months) after primary transplantation
description: Coronary Artery Vasculopathy (CAV)
International Society for Heart and Lung Transplantation Registry (ISHLT)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Peter S Heeger, M.D.
role: Study Chair
affiliation: Icahn School of Medicine at Mount Sinai
last name: Anil K. Chandraker, M.D.
role: Study Chair
affiliation: Brigham and Women's Hospital
facility: 
facility: 
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country: United States
url: http://www.niaid.nih.gov
description: The National Institute of Allergy and Infectious Diseases (NIAID)
url: https://www.ctotstudies.org/
description: Clinical Trials in Organ Transplantation (CTOT)
citation: Starling RC, Stehlik J, Baran DA, Armstrong B, Stone JR, Ikle D, Morrison Y, Bridges ND, Putheti P, Strom TB, Bhasin M, Guleria I, Chandraker A, Sayegh M, Daly KP, Briscoe DM, Heeger PS; CTOT-05 consortium. Multicenter Analysis of Immune Biomarkers and Heart Transplant Outcomes: Results of the Clinical Trials in Organ Transplantation-05 Study. Am J Transplant. 2016 Jan;16(1):121-36. doi: 10.1111/ajt.13422. Epub 2015 Aug 10.
PMID: 26260101
responsible party type: Sponsor