<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/NCT02212496</url>
  </required_header>
  <id_info>
    <org_study_id>2014-07-136</org_study_id>
    <nct_id>NCT02212496</nct_id>
  </id_info>
  <brief_title>Identification the Cause of Cerebral Infarction in Patients With Cancer</brief_title>
  <official_title>Identification the Cause of Cerebral Infarction in Patients With Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Although there has been increasing interest in the association between cancer and&#xD;
      cerebrovascular disease, the underlying pathophysiology of stroke in cancer patients is still&#xD;
      not fully understood. The aim of this study is to investigate the stroke mechanisms in&#xD;
      patients with cancer-associated stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with cryptogenic embolic stroke will be prospectively enrolled and categorized into&#xD;
      two groups according to the presence of active cancer: cryptogenic embolic stroke with active&#xD;
      cancer (cancer-associated stroke) vs. without active cancer (cryptogenic embolic stroke). All&#xD;
      patients will undergo brain MRI/MRA, 12-lead electrocardiography, transthoracic and&#xD;
      transesophageal echocardiography with injection of agitated saline, and 24-hour Holter and/or&#xD;
      telemonitoring. Duplex ultrasonography to detect venous thrombosis of the lower extremity&#xD;
      will also be performed in patients with a positive right-to-left shunt on echocardiography.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</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>Prevalence of deep vein thrombosis and microembolic signal in cancer related stroke patients</measure>
    <time_frame>Within one week after enrollment</time_frame>
    <description>Venous thromboembolism was investigated via Doppler sonography and/or computed tomography pulmonary angiography combined with venous phase CT angiography of the lower extremities. Microembolic signal was detected via transcranial Doppler sonography on symptomatic cerebral circulation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of intravascular thrombosis on infarct volume</measure>
    <time_frame>Within one week after enrollment</time_frame>
    <description>Infarct volume was measured by diffusion-weighted MR imaging and apparent diffusion coefficient calculated from imaging data. Univariate and multivariate linear regression was performed in ESUS patients with cancer (adjusted for age, sex, overt DIC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of intravascular thrombosis on survival</measure>
    <time_frame>Till the event of death occurs in enrolled patients</time_frame>
    <description>Survival time (in years) was measured by subtracting admission date from the date the patient had expired. Cox proportional hazard analysis was used to evaluate association between intravascular thrombosis and survival (adjusted for age, sex, NIHSS, presence of overt DIC, infarct volume, metastasis, and histologic type).</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">118</enrollment>
  <condition>Cryptogenic Embolic Stroke</condition>
  <condition>Active Cancer</condition>
  <arm_group>
    <arm_group_label>Cancer-associated stroke</arm_group_label>
    <description>Cryptogenic embolic stroke with active cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cryptogenic embolic stroke</arm_group_label>
    <description>Cryptogenic embolic stroke without active cancer</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Embolic stroke of undetermined source with or without cancer, admitted to Samsung Medical&#xD;
        Center (tertiary hospital with comprehensive stroke and cancer center)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with acute ischemic stroke who presented within 7 days from symptom onset&#xD;
&#xD;
          -  Subjects who had embolic infarction outside the perforator territory revealed by&#xD;
             diffusion-weighted imaging&#xD;
&#xD;
          -  Subjects with undetermined cause of stroke despite of initial evaluation including&#xD;
             electrocardiogram and brain imaging upon admission&#xD;
&#xD;
          -  Subjects who performed brain magnetic resonance image (MRI) and MR angiography (MRA),&#xD;
             cardiac work-ups (12-lead electrocardiography, transthoracic and/or transesophageal&#xD;
             echocardiography with injection of agitated saline (or agitated saline transcranial&#xD;
             Doppler monitoring), and 24-hour Holter and/or telemonitoring)&#xD;
&#xD;
          -  Subjects with informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with single subcortical infarction&#xD;
&#xD;
          -  Subjects with primary brain tumor&#xD;
&#xD;
          -  Inability to perform comprehensive studies&#xD;
&#xD;
          -  Refusal or withdrawal of the consent&#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>Chin-Sang Chung, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>July 2, 2019</last_update_submitted>
  <last_update_submitted_qc>July 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Chin-Sang Chung</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Embolic Stroke</mesh_term>
    <mesh_term>Infarction</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/NCT02212496
org study id: 2014-07-136
nct id: NCT02212496
lead sponsor: 
has dmc: No
Although there has been increasing interest in the association between cancer and
      cerebrovascular disease, the underlying pathophysiology of stroke in cancer patients is still
      not fully understood. The aim of this study is to investigate the stroke mechanisms in
      patients with cancer-associated stroke.
Patients with cryptogenic embolic stroke will be prospectively enrolled and categorized into
      two groups according to the presence of active cancer: cryptogenic embolic stroke with active
      cancer (cancer-associated stroke) vs. without active cancer (cryptogenic embolic stroke). All
      patients will undergo brain MRI/MRA, 12-lead electrocardiography, transthoracic and
      transesophageal echocardiography with injection of agitated saline, and 24-hour Holter and/or
      telemonitoring. Duplex ultrasonography to detect venous thrombosis of the lower extremity
      will also be performed in patients with a positive right-to-left shunt on echocardiography.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of deep vein thrombosis and microembolic signal in cancer related stroke patients
time frame: Within one week after enrollment
description: Venous thromboembolism was investigated via Doppler sonography and/or computed tomography pulmonary angiography combined with venous phase CT angiography of the lower extremities. Microembolic signal was detected via transcranial Doppler sonography on symptomatic cerebral circulation
measure: Impact of intravascular thrombosis on infarct volume
time frame: Within one week after enrollment
description: Infarct volume was measured by diffusion-weighted MR imaging and apparent diffusion coefficient calculated from imaging data. Univariate and multivariate linear regression was performed in ESUS patients with cancer (adjusted for age, sex, overt DIC).
measure: Impact of intravascular thrombosis on survival
time frame: Till the event of death occurs in enrolled patients
description: Survival time (in years) was measured by subtracting admission date from the date the patient had expired. Cox proportional hazard analysis was used to evaluate association between intravascular thrombosis and survival (adjusted for age, sex, NIHSS, presence of overt DIC, infarct volume, metastasis, and histologic type).
arm group label: Cancer-associated stroke
description: Cryptogenic embolic stroke with active cancer
arm group label: Cryptogenic embolic stroke
description: Cryptogenic embolic stroke without active cancer
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chin-Sang Chung, MD, PhD
role: Principal Investigator
affiliation: Samsung Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Chin-Sang Chung
investigator title: MD, PhD
mesh term: Cerebral Infarction
mesh term: Embolic Stroke
mesh term: Infarction