<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/NCT02974192</url>
  </required_header>
  <id_info>
    <org_study_id>IIRB0000871432</org_study_id>
    <nct_id>NCT02974192</nct_id>
  </id_info>
  <brief_title>Neopterin Effects on Ischemic Stroke</brief_title>
  <official_title>Neoptrin, Soluble CD40-ligand and Ischemic Stroke: a Clinical Perspective</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ischemic stroke accounts for the majority of stroke cases and constitutes a major cause of&#xD;
      death and disability in industrial world. Inflammation has been reported to constitute a&#xD;
      major component of ischemic stroke pathology. The brain responds to ischemic injury with an&#xD;
      acute andprolonged inflammatory process. Few studies have investigated the relationship&#xD;
      between acute biomarkers of inflammation and functional outcome following stroke&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This case -control observational prospective study will be conducted on 100 patients with&#xD;
      first -ever acute onset ischemic stroke within 24-48 hours. Their ages ranged-years old (mean&#xD;
      age ±years). All participants will be subjected to thorough history taking, full clinical and&#xD;
      neurological examination. Complete neurological examination where the following clinical and&#xD;
      demographical data will be taken; age sex, stroke etiology, presence of stroke risk factors&#xD;
      (as smoking history , hyperlipidemia, diabetes mellitus , history of hypertension, history of&#xD;
      transient ischemic attacks, history of myocardial infarction or any cardiac problems). Stroke&#xD;
      subtype will be classified according to the criteria of Trial of Org 10172 in acute Stroke&#xD;
      Treatment (TOAST) classification. The clinical stroke syndrome will be determined by applying&#xD;
      the criteria of the Oxfordshire Community Stroke project (OCSP). Stroke severity will be&#xD;
      assessed by Scandinavian Stroke Scale (SSS) and Modified Rankin Scale (mRS) will be measured&#xD;
      at the time of admission. Brain imaging (either CT scan and /or MRI) will be performed after&#xD;
      admission. Electrocardiography (ECG), Echocardiography (ECHO), Carotid and vertibrobasilar&#xD;
      Duplex will be done for all patients. Blood samples will be drawn for assessment of complete&#xD;
      blood picture (CBC), Random blood glucose levels, renal function tests (RFT), liver function&#xD;
      tests (LFT), thyroid function tests (TFT), Lipid profile, Soluble CD40 Ligand and Neopetrin&#xD;
      by using standard laboratory methods on the first day of admission.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">March 2017</completion_date>
  <primary_completion_date type="Anticipated">March 2017</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Neopterin level</measure>
    <time_frame>Within the first 24 hours</time_frame>
    <description>will be measured by using standard laboratory methods on the first day of admission</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Soluble CD40 Ligand</measure>
    <time_frame>Within the first 24 hours</time_frame>
    <description>will be measured by using standard laboratory methods on the first day of admission</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stroke subtype</measure>
    <time_frame>Within the first 24 hours</time_frame>
    <description>will be classified according to the criteria of Trial of Org 10172 in acute Stroke Treatment (TOAST) classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The clinical stroke syndrome</measure>
    <time_frame>Within the first 24 hours</time_frame>
    <description>will be determined by applying the criteria of the Oxfordshire Community Stroke project (OCSP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke severity</measure>
    <time_frame>Within the first 24 hours</time_frame>
    <description>Stroke severity will be assessed by Scandinavian Stroke Scale (SSS) and Modified Rankin Scale (mRS) will be measured at the time of admission.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Stroke</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neopterin</intervention_name>
    <description>Neopterin will be measured by using standard laboratory methods on the first day of admission.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with first -ever acute onset ischemic stroke within 24-48 hours&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Onset is within one week&#xD;
&#xD;
          -  Confirmed stroke by brain CAT and / or MRI scan infarction&#xD;
&#xD;
          -  Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive and mental changes&#xD;
&#xD;
          -  Recurrent stroke&#xD;
&#xD;
          -  Hepatic and renal impairment&#xD;
&#xD;
          -  Endocrinal diseases&#xD;
&#xD;
          -  Steroid therapy&#xD;
&#xD;
          -  Previous fractures&#xD;
&#xD;
          -  brain neoplasm,&#xD;
&#xD;
          -  Autoimmune diseases&#xD;
&#xD;
          -  History of acute and chronic inflammatory diseases&#xD;
&#xD;
          -  Malignancy,&#xD;
&#xD;
          -  Trauma&#xD;
&#xD;
          -  Surgery&#xD;
&#xD;
          -  Acute vascular diseases that occurred within four weeks prior the onset of stroke&#xD;
             History myocardial infarction ˂3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sayed k Abd-Elshafy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate professor of anesthesia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sayed K Abd-Elshafy, MD</last_name>
    <phone>0020882413203</phone>
    <email>sayed_k_72@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculty of Medicine</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>mohamed abdelatef, MD</last_name>
      <phone>0020882413201</phone>
      <email>latif_mohamed@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>January 14, 2017</last_update_submitted>
  <last_update_submitted_qc>January 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Sayed Kaoud Abd-Elshafy</investigator_full_name>
    <investigator_title>Associate profossor of anesthesia</investigator_title>
  </responsible_party>
  <keyword>Ischemic stroke</keyword>
  <keyword>Soluble CD40 Ligand</keyword>
  <keyword>Neopetrin</keyword>
  <keyword>stroke risk factors</keyword>
  <keyword>functional outcome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</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/NCT02974192
org study id: IIRB0000871432
nct id: NCT02974192
lead sponsor: 
has dmc: Yes
Ischemic stroke accounts for the majority of stroke cases and constitutes a major cause of
      death and disability in industrial world. Inflammation has been reported to constitute a
      major component of ischemic stroke pathology. The brain responds to ischemic injury with an
      acute andprolonged inflammatory process. Few studies have investigated the relationship
      between acute biomarkers of inflammation and functional outcome following stroke
This case -control observational prospective study will be conducted on 100 patients with
      first -ever acute onset ischemic stroke within 24-48 hours. Their ages ranged-years old (mean
      age ±years). All participants will be subjected to thorough history taking, full clinical and
      neurological examination. Complete neurological examination where the following clinical and
      demographical data will be taken; age sex, stroke etiology, presence of stroke risk factors
      (as smoking history , hyperlipidemia, diabetes mellitus , history of hypertension, history of
      transient ischemic attacks, history of myocardial infarction or any cardiac problems). Stroke
      subtype will be classified according to the criteria of Trial of Org 10172 in acute Stroke
      Treatment (TOAST) classification. The clinical stroke syndrome will be determined by applying
      the criteria of the Oxfordshire Community Stroke project (OCSP). Stroke severity will be
      assessed by Scandinavian Stroke Scale (SSS) and Modified Rankin Scale (mRS) will be measured
      at the time of admission. Brain imaging (either CT scan and /or MRI) will be performed after
      admission. Electrocardiography (ECG), Echocardiography (ECHO), Carotid and vertibrobasilar
      Duplex will be done for all patients. Blood samples will be drawn for assessment of complete
      blood picture (CBC), Random blood glucose levels, renal function tests (RFT), liver function
      tests (LFT), thyroid function tests (TFT), Lipid profile, Soluble CD40 Ligand and Neopetrin
      by using standard laboratory methods on the first day of admission.
observational model: Case-Control
time perspective: Prospective
measure: Neopterin level
time frame: Within the first 24 hours
description: will be measured by using standard laboratory methods on the first day of admission
measure: Soluble CD40 Ligand
time frame: Within the first 24 hours
description: will be measured by using standard laboratory methods on the first day of admission
measure: Stroke subtype
time frame: Within the first 24 hours
description: will be classified according to the criteria of Trial of Org 10172 in acute Stroke Treatment (TOAST) classification
measure: The clinical stroke syndrome
time frame: Within the first 24 hours
description: will be determined by applying the criteria of the Oxfordshire Community Stroke project (OCSP)
measure: Stroke severity
time frame: Within the first 24 hours
description: Stroke severity will be assessed by Scandinavian Stroke Scale (SSS) and Modified Rankin Scale (mRS) will be measured at the time of admission.
intervention type: Other
intervention name: Neopterin
description: Neopterin will be measured by using standard laboratory methods on the first day of admission.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Sayed k Abd-Elshafy, MD
role: Principal Investigator
affiliation: Associate professor of anesthesia
last name: Sayed K Abd-Elshafy, MD
phone: 0020882413203
email: sayed_k_72@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Sayed Kaoud Abd-Elshafy
investigator title: Associate profossor of anesthesia
mesh term: Stroke
mesh term: Ischemic Stroke
sharing ipd: Undecided