<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/NCT01705353</url>
  </required_header>
  <id_info>
    <org_study_id>12-090B</org_study_id>
    <nct_id>NCT01705353</nct_id>
  </id_info>
  <brief_title>The Role of HMGB-1 in Chronic Stroke</brief_title>
  <official_title>Pilot Study of the Role of HMGB-1 in Retarding Recovery in Chronic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwell Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to measure the presence of HMGB-1 and other proteins in the&#xD;
      blood across five time points after stroke, and to determine if their presence correlates&#xD;
      with rate of stroke recovery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stroke, cerebrovascular accident, is the leading cause of brain injury and the leading cause&#xD;
      of permanent disability. The acute pathophysiology of stroke depends on the innate immune&#xD;
      response, which arises from mostly pro-inflammatory cascades. The chronic pathophysiology of&#xD;
      stroke is less clear as the innate inflammatory response fades and matures into an adaptive&#xD;
      immune response. HMGB-1 is a serum cytokine that has been found with persistent elevated&#xD;
      levels for weeks to months after neurological insult in preclinical experiments, and may&#xD;
      retard functional recovery. Elucidation of the relationship between HMGB-1 levels and the&#xD;
      rate of functional recovery after stroke could lead to a better understanding of the systemic&#xD;
      inflammatory response and more targeted therapeutic interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    study stopped because patient access became extremely limited for the initial data entry point.&#xD;
  </why_stopped>
  <start_date type="Actual">September 2012</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Cytokine levels (HMGB-1) in plasma samples</measure>
    <time_frame>day 1, day7, day 14, day 30, day 90</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>NIH and Rankin Clinical Measures of functional recovery</measure>
    <time_frame>day 1, day7, day 14, day 30, day 90</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">39</enrollment>
  <condition>Cerebrovascular Accident</condition>
  <condition>Cerebral Stroke</condition>
  <condition>Stroke, Acute</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood, DNA, serum/serum cytokines&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Acute care hospital (stroke unit)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted to the stroke service at Northshore and LIJ Medical Centers&#xD;
&#xD;
          -  Patients 18 years of age or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients &lt; 18 years of age&#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>Bruce T Volpe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Feinstein Institute for Medical Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>North Shore University Hospital</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Long Island Jewish Medical Center</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Muhammad S, Barakat W, Stoyanov S, Murikinati S, Yang H, Tracey KJ, Bendszus M, Rossetti G, Nawroth PP, Bierhaus A, Schwaninger M. The HMGB1 receptor RAGE mediates ischemic brain damage. J Neurosci. 2008 Nov 12;28(46):12023-12031. doi: 10.1523/JNEUROSCI.2435-08.2008.</citation>
    <PMID>19005067</PMID>
  </reference>
  <reference>
    <citation>Goldstein RS, Gallowitsch-Puerta M, Yang L, Rosas-Ballina M, Huston JM, Czura CJ, Lee DC, Ward MF, Bruchfeld AN, Wang H, Lesser ML, Church AL, Litroff AH, Sama AE, Tracey KJ. Elevated high-mobility group box 1 levels in patients with cerebral and myocardial ischemia. Shock. 2006 Jun;25(6):571-4. doi: 10.1097/01.shk.0000209540.99176.72.</citation>
    <PMID>16721263</PMID>
  </reference>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>March 9, 2018</last_update_submitted>
  <last_update_submitted_qc>March 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwell Health</investigator_affiliation>
    <investigator_full_name>Bruce Volpe</investigator_full_name>
    <investigator_title>Investigator (MD)</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Cerebrovascular Accident</keyword>
  <keyword>HMGB-1</keyword>
  <keyword>cytokines</keyword>
  <keyword>functional recovery</keyword>
  <keyword>inflammation</keyword>
  <keyword>immune response</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 24, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT01705353/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT01705353
org study id: 12-090B
nct id: NCT01705353
lead sponsor: 
has dmc: Yes
The purpose of this study is to measure the presence of HMGB-1 and other proteins in the
      blood across five time points after stroke, and to determine if their presence correlates
      with rate of stroke recovery.
Stroke, cerebrovascular accident, is the leading cause of brain injury and the leading cause
      of permanent disability. The acute pathophysiology of stroke depends on the innate immune
      response, which arises from mostly pro-inflammatory cascades. The chronic pathophysiology of
      stroke is less clear as the innate inflammatory response fades and matures into an adaptive
      immune response. HMGB-1 is a serum cytokine that has been found with persistent elevated
      levels for weeks to months after neurological insult in preclinical experiments, and may
      retard functional recovery. Elucidation of the relationship between HMGB-1 levels and the
      rate of functional recovery after stroke could lead to a better understanding of the systemic
      inflammatory response and more targeted therapeutic interventions.
observational model: Cohort
time perspective: Prospective
measure: Cytokine levels (HMGB-1) in plasma samples
time frame: day 1, day7, day 14, day 30, day 90
measure: NIH and Rankin Clinical Measures of functional recovery
time frame: day 1, day7, day 14, day 30, day 90
Whole blood, DNA, serum/serum cytokines
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bruce T Volpe, MD
role: Principal Investigator
affiliation: Feinstein Institute for Medical Research
facility: 
facility: 
country: United States
citation: Muhammad S, Barakat W, Stoyanov S, Murikinati S, Yang H, Tracey KJ, Bendszus M, Rossetti G, Nawroth PP, Bierhaus A, Schwaninger M. The HMGB1 receptor RAGE mediates ischemic brain damage. J Neurosci. 2008 Nov 12;28(46):12023-12031. doi: 10.1523/JNEUROSCI.2435-08.2008.
PMID: 19005067
citation: Goldstein RS, Gallowitsch-Puerta M, Yang L, Rosas-Ballina M, Huston JM, Czura CJ, Lee DC, Ward MF, Bruchfeld AN, Wang H, Lesser ML, Church AL, Litroff AH, Sama AE, Tracey KJ. Elevated high-mobility group box 1 levels in patients with cerebral and myocardial ischemia. Shock. 2006 Jun;25(6):571-4. doi: 10.1097/01.shk.0000209540.99176.72.
PMID: 16721263
responsible party type: Principal Investigator
investigator affiliation: Northwell Health
investigator full name: Bruce Volpe
investigator title: Investigator (MD)
mesh term: Stroke
provided document: 