<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/NCT01711255</url>
  </required_header>
  <id_info>
    <org_study_id>BU-12A-1323</org_study_id>
    <nct_id>NCT01711255</nct_id>
  </id_info>
  <brief_title>Evaluation of Coagulation in Multiple Sclerosis</brief_title>
  <official_title>A Cross-Sectional Study of Coagulation in Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bastyr University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bastyr University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recent research in multiple sclerosis (MS) have suggested that altered coagulation and&#xD;
      vascular inflammation may play a role in pathophysiology of MS. Sonoclot is viscoelastic&#xD;
      method of analyzing clot formation. This instrument will be used to compare coagulation in&#xD;
      individuals with MS to healthy controls. A 24-hour dietary recall and food frequency&#xD;
      questionnaire will help determine whether coagulation is modified by fish consumption.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This case-control study will recruit individuals with a diagnosis of MS and healthy controls.&#xD;
      Individuals will be asked to come to Bastyr Clinical Research Center for a single study&#xD;
      visit, at which time dietary intake, current medications and supplements, other medical&#xD;
      diagnoses, and coagulation will be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sonoclot Coagulation Spectrum (Sonoclot Signature)</measure>
    <time_frame>Day 1</time_frame>
    <description>The Sonoclot Coagulation Spectrum represents a combination of coagulation parameters, including activated clotting time, clot rate, time to peak, and peak amplitude. The mean value of all contributing parameters will be compared between cases and controls.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ASA24 omega-3 fatty acid intake</measure>
    <time_frame>24 hour recall (24 hours prior to study visit)</time_frame>
    <description>The ASA24, in combination with a medication history, will be used to evaluate whether omega-3 fatty acid intake is associated with reduced rates of coagulation in either cases or controls.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">69</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Multiple Sclerosis</arm_group_label>
    <description>Subjects who have been diagnosed with clinically definite or probable multiple sclerosis as defined and recorded by board certified neurologist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy controls</arm_group_label>
    <description>Adults age 18 and older who have not been diagnosed with any neurological, endocrine, or other chronic health condition. They must also be free of any recent acute illness that can impact inflammation/clotting.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Six (6) whole blood vials of 10ml each will be collected from each subject. Three (3) will be&#xD;
      stored for future use. Three will be used immediately for coagulation analysis using&#xD;
      Sonoclot.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Study population will be sixty (60) individuals with diagnosed or probable multiple&#xD;
        sclerosis, verified by board certified neurologist, and forty (40) age and sex matched&#xD;
        healthy controls.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of clinically probable of clinically definite multiple sclerosis made by&#xD;
             board certified neurologist. Subject must be willing to release medical information&#xD;
             regarding diagnosis&#xD;
&#xD;
          -  Controls must consider themselves healthy and be free of any neurological, autoimmune,&#xD;
             endocrine or other chronic disease. Must also be free of any recent acute&#xD;
             illness/injury that can influence inflammatory activity.&#xD;
&#xD;
          -  Individuals must be 18 or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of coagulation defect&#xD;
&#xD;
          -  Use of anticoagulants (eg. warfarin, coumadin) or Aspirin within 30 days of entry.&#xD;
&#xD;
          -  NSAID within 7 days of entry (dietary intake of fish oil or tumeric is acceptable)&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laurie K Mischley, ND</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bastyr University - Clinical Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bastyr University Clinical Research Center</name>
      <address>
        <city>Kenmore</city>
        <state>Washington</state>
        <zip>98028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.bastyr.edu/research/clinical-research-center/integrative-neuroscience-research</url>
    <description>Related info</description>
  </link>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <last_update_submitted>July 27, 2017</last_update_submitted>
  <last_update_submitted_qc>July 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple sclerosis</keyword>
  <keyword>Coagulation</keyword>
  <keyword>Alternative Medicine</keyword>
  <keyword>Clotting</keyword>
  <keyword>Complementary Medicine</keyword>
  <keyword>Inflammation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</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/NCT01711255
org study id: BU-12A-1323
nct id: NCT01711255
lead sponsor: 
has dmc: No
Recent research in multiple sclerosis (MS) have suggested that altered coagulation and
      vascular inflammation may play a role in pathophysiology of MS. Sonoclot is viscoelastic
      method of analyzing clot formation. This instrument will be used to compare coagulation in
      individuals with MS to healthy controls. A 24-hour dietary recall and food frequency
      questionnaire will help determine whether coagulation is modified by fish consumption.
This case-control study will recruit individuals with a diagnosis of MS and healthy controls.
      Individuals will be asked to come to Bastyr Clinical Research Center for a single study
      visit, at which time dietary intake, current medications and supplements, other medical
      diagnoses, and coagulation will be evaluated.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Sonoclot Coagulation Spectrum (Sonoclot Signature)
time frame: Day 1
description: The Sonoclot Coagulation Spectrum represents a combination of coagulation parameters, including activated clotting time, clot rate, time to peak, and peak amplitude. The mean value of all contributing parameters will be compared between cases and controls.
measure: ASA24 omega-3 fatty acid intake
time frame: 24 hour recall (24 hours prior to study visit)
description: The ASA24, in combination with a medication history, will be used to evaluate whether omega-3 fatty acid intake is associated with reduced rates of coagulation in either cases or controls.
arm group label: Multiple Sclerosis
description: Subjects who have been diagnosed with clinically definite or probable multiple sclerosis as defined and recorded by board certified neurologist.
arm group label: Healthy controls
description: Adults age 18 and older who have not been diagnosed with any neurological, endocrine, or other chronic health condition. They must also be free of any recent acute illness that can impact inflammation/clotting.
Six (6) whole blood vials of 10ml each will be collected from each subject. Three (3) will be
      stored for future use. Three will be used immediately for coagulation analysis using
      Sonoclot.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Laurie K Mischley, ND
role: Principal Investigator
affiliation: Bastyr University - Clinical Research Center
facility: 
country: United States
url: http://www.bastyr.edu/research/clinical-research-center/integrative-neuroscience-research
description: Related info
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis