<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/NCT01665729</url>
  </required_header>
  <id_info>
    <org_study_id>2011-2-48</org_study_id>
    <nct_id>NCT01665729</nct_id>
  </id_info>
  <brief_title>Diagnosis and Treatment of Minor Ischaemic Stroke According to the Etiology and Pathogenesis</brief_title>
  <official_title>Diagnosis and Treatment of Minor Ischaemic Stroke According to the Etiology and Pathogenesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Li Haiyan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Third Affiliated Hospital, Sun Yat-Sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Negligence or contempt of the etiology and pathogenesis of minor ischaemic stroke in the&#xD;
      early diagnosis and effective treatment leads to more than 40-50% of patient with recurrent&#xD;
      episodes, and 10% patient died. Therefore, diagnosis and treatment of minor ischaemic stroke&#xD;
      according to the etiology and pathogenesis is important.&#xD;
&#xD;
      The 2007 Korean modified TOAST type got some progress, but there exists two major&#xD;
      disadvantages: imperfect diagnosis and pathogenesis of perforator artery infarction etiology;&#xD;
      lack of typing according to the pathogenesis of large atherosclerotic infarction and taking&#xD;
      measures of treatment according to the new types. Recently, domestic professor Gaoshan&#xD;
      proposes new approach to diagnose and treat minor ischaemic stroke according to the etiology&#xD;
      and pathogenesis of CISS typing, but the pathogenesis of hypoperfusion infarction with severe&#xD;
      stenosis of large artery is unclear. Is it low perfusion? Or artery-artery embolization? Or&#xD;
      both? How to distinguish the pathogenesis of branch artery disease: by atherosclerosis? Or&#xD;
      hyalinosis? Or both? How to check the validity of clinical types? This study take different&#xD;
      interventions according to different types and observation of the long term clinical results&#xD;
      of intervention( mortality, recurrence rate, disability rate and rate of cerebral hemorrhage&#xD;
      and subarachnoid hemorrhage), in order to clarify the new types can indeed solve the current&#xD;
      problem of minor ischaemic stroke with high mortality, recurrence rate, disability rate and&#xD;
      rate of cerebral hemorrhage and subarachnoid hemorrhage.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2011</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Actual">August 2012</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>Prospective</time_perspective>
  </study_design_info>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Ischaemic Stroke</condition>
  <arm_group>
    <arm_group_label>artery-artery embolus</arm_group_label>
    <description>There is no hypoperfusion ( contralateral compensatory is good )</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hypoperfusion</arm_group_label>
    <description>Contralateral compensatory not sufficient</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hypoperfusion and embolus amotic</arm_group_label>
    <description>Hypoperfusion and embolus amotic</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        patients with new emergence of minor ischaemic stroke ( one of two conditions: (1)&#xD;
        conscious patients with any of NIHSS score = 1,or (2) NIHSS ≤ 3 )&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        one of two conditions:&#xD;
&#xD;
          1. conscious patients with any of NIHSS score = 1,or&#xD;
&#xD;
          2. NIHSS ≤ 3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients Over 80 years of age&#xD;
&#xD;
          -  patients With serious heart, lung, liver, kidney dysfunction or&#xD;
&#xD;
          -  severe systemic complications,&#xD;
&#xD;
          -  a known tumor,&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  having a history of cerebral hemorrhage&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhengqi Lu, prof.</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Neurology,The Third Afﬁliated Hospital of Sun yat-sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhengqi Lu, prof.</last_name>
    <phone>86 13570102668</phone>
    <email>lzq1828@yahoo.com.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Haiyan Li, Dr.</last_name>
    <phone>86 15920474159</phone>
    <email>lihaiyan162@yahoo.com.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Neurology,The Third Afﬁliated Hospital of Sun yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510630</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhengqi Lu, prof.</last_name>
      <phone>86 13570102668</phone>
      <email>lzq1828@yahoo.com.cn</email>
    </contact>
    <contact_backup>
      <last_name>Haiyan Li</last_name>
      <phone>86 15920474159</phone>
      <email>lihaiyan162@yahoo.com.cn</email>
    </contact_backup>
    <investigator>
      <last_name>Zhengqi Lu, prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 12, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>August 14, 2012</last_update_submitted>
  <last_update_submitted_qc>August 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Third Affiliated Hospital, Sun Yat-Sen University</investigator_affiliation>
    <investigator_full_name>Li Haiyan</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>etiology</keyword>
  <keyword>pathogenesis</keyword>
  <keyword>minor ischaemic stroke</keyword>
  <keyword>types</keyword>
  <keyword>intervention</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>
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Ischemia</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/NCT01665729
org study id: 2011-2-48
nct id: NCT01665729
lead sponsor: 
has dmc: Yes
Negligence or contempt of the etiology and pathogenesis of minor ischaemic stroke in the
      early diagnosis and effective treatment leads to more than 40-50% of patient with recurrent
      episodes, and 10% patient died. Therefore, diagnosis and treatment of minor ischaemic stroke
      according to the etiology and pathogenesis is important.

      The 2007 Korean modified TOAST type got some progress, but there exists two major
      disadvantages: imperfect diagnosis and pathogenesis of perforator artery infarction etiology;
      lack of typing according to the pathogenesis of large atherosclerotic infarction and taking
      measures of treatment according to the new types. Recently, domestic professor Gaoshan
      proposes new approach to diagnose and treat minor ischaemic stroke according to the etiology
      and pathogenesis of CISS typing, but the pathogenesis of hypoperfusion infarction with severe
      stenosis of large artery is unclear. Is it low perfusion? Or artery-artery embolization? Or
      both? How to distinguish the pathogenesis of branch artery disease: by atherosclerosis? Or
      hyalinosis? Or both? How to check the validity of clinical types? This study take different
      interventions according to different types and observation of the long term clinical results
      of intervention( mortality, recurrence rate, disability rate and rate of cerebral hemorrhage
      and subarachnoid hemorrhage), in order to clarify the new types can indeed solve the current
      problem of minor ischaemic stroke with high mortality, recurrence rate, disability rate and
      rate of cerebral hemorrhage and subarachnoid hemorrhage.
observational model: Case-Only
time perspective: Prospective
arm group label: artery-artery embolus
description: There is no hypoperfusion ( contralateral compensatory is good )
arm group label: Hypoperfusion
description: Contralateral compensatory not sufficient
arm group label: Hypoperfusion and embolus amotic
description: Hypoperfusion and embolus amotic
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 79 Years
healthy volunteers: No
last name: Zhengqi Lu, prof.
role: Study Chair
affiliation: Department of Neurology,The Third Afﬁliated Hospital of Sun yat-sen University
last name: Zhengqi Lu, prof.
phone: 86 13570102668
email: lzq1828@yahoo.com.cn
last name: Haiyan Li, Dr.
phone: 86 15920474159
email: lihaiyan162@yahoo.com.cn
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Third Affiliated Hospital, Sun Yat-Sen University
investigator full name: Li Haiyan
investigator title: Dr.
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Cerebral Infarction
mesh term: Ischemia