<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/NCT02251665</url>
  </required_header>
  <id_info>
    <org_study_id>NationalCardioCenter</org_study_id>
    <nct_id>NCT02251665</nct_id>
  </id_info>
  <brief_title>National Cerebral and Cardiovascular Center (NCVC) Stroke Registry</brief_title>
  <official_title>National Cerebral and Cardiovascular Center (NCVC) Stroke Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cerebral and Cardiovascular Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cerebral and Cardiovascular Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A single-center registry of patients with acute ischemic stroke, intracerebral hemorrhage,&#xD;
      and transient ischemic attack (TIA) who are emergently managed in the stroke care unit in the&#xD;
      National Cerebral and Cardiovascular Center (NCVC) to determine change in underlying&#xD;
      characteristics, stroke features and severity, process for diagnosis and acute treatment, and&#xD;
      long-term outcomes of stroke/TIA patients over the years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-center registry of consecutive patients with acute ischemic stroke,&#xD;
      intracerebral hemorrhage, and transient ischemic attack (TIA) who are emergently managed in&#xD;
      the stroke care unit in the National Cerebral and Cardiovascular Center, a flagship stroke&#xD;
      center in Japan.&#xD;
&#xD;
      Neurological emergencies other than stroke/TIA and subclinical cerebrobvascular inpatients&#xD;
      are also enrolled.&#xD;
&#xD;
      Data are collected and analyzed to determine change in underlying characteristics, stroke&#xD;
      features and severity, process for diagnosis and acute treatment, and long-term outcomes of&#xD;
      stroke/TIA patients over the years.&#xD;
&#xD;
      The National Cerebral and Cardiovascular Center was founded in 1977 in Suita, Osaka, in order&#xD;
      to provide the public with the most advanced treatment for cardiovascular and cerebrovascular&#xD;
      diseases and to conduct the highest level of basic as well as applied research on the&#xD;
      cardiovascular and cerebrovascular systems.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Anticipated">March 2025</completion_date>
  <primary_completion_date type="Anticipated">June 2021</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>
  <primary_outcome>
    <measure>The modified Rankin Scale (mRS), a measure of disability</measure>
    <time_frame>3 monhts</time_frame>
    <description>mRS scores range from 0 (no symptoms at all) to 6 (death)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants</measure>
    <time_frame>at entry</time_frame>
    <description>Also assessing underlying patients' characteristics prior to index stroke/TIA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>National Institutes of Health Stroke Scale score</measure>
    <time_frame>at entry</time_frame>
    <description>Also assessing neurological and cognitive states</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of culprit infarcts/hematoma</measure>
    <time_frame>at entry</time_frame>
    <description>ASPECTS on DWI for ischemia or hematoma volume using the ABC/2 method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The modified Rankin Scale (mRS), a measure of disability</measure>
    <time_frame>around 3 weeks</time_frame>
    <description>mRS scores range from 0 (no symptoms at all) to 6 (death). Participants will be followed at hospital discharge, an expected average of 3 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The modified Rankin Scale (mRS), a measure of disability</measure>
    <time_frame>1 year</time_frame>
    <description>mRS scores range from 0 (no symptoms at all) to 6 (death)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Events of cardiovascular diseases including stroke/TIA</measure>
    <time_frame>around 3 weeks</time_frame>
    <description>Participants will be followed at hospital discharge, an expected average of 3 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Events of cardiovascular diseases including stroke/TIA</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Events of cardiovascular diseases including stroke/TIA</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">5374</enrollment>
  <condition>Stroke, Acute</condition>
  <arm_group>
    <arm_group_label>Acute ischemic stroke, acute ICH, TIA</arm_group_label>
    <description>Consecutive patients with acute ischemic stroke, intracerebral hemorrhage, and transient ischemic attack who are emergently managed in the stroke care unit or stroke units in the National Cerebral and Cardiovascular Center</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>a single-center prospective observational study</description>
    <arm_group_label>Acute ischemic stroke, acute ICH, TIA</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Inpatients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. A patient with acute ischemic stroke, intracerebral hemorrhage, and transient ischemic&#xD;
             attack who are emergently managed in the stroke care unit or stroke units in the&#xD;
             National Cerebral and Cardiovascular Center (NCVC)&#xD;
&#xD;
          2. Consent to participate in the registration by a patient or relatives obtained using an&#xD;
             opt-out approach by the demonstrating contents of the registration on the hospital&#xD;
             bulletin board&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1) Patients considered by the investigator to be unsuitable for participating in this&#xD;
        registry&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kazunori Toyoda, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vice Director of the Hospital, National Cerebral and Cardiovascular Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Cerebral and Cardiovascular Center</name>
      <address>
        <city>Suita</city>
        <state>Osaka</state>
        <zip>564-8565</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>http://www.ncvc.go.jp/english/index.html</url>
    <description>Official home page of the National Cerebral and Cardiovascular Center</description>
  </link>
  <results_reference>
    <citation>Toyoda K, Ninomiya T. Stroke and cerebrovascular diseases in patients with chronic kidney disease. Lancet Neurol. 2014 Aug;13(8):823-33. doi: 10.1016/S1474-4422(14)70026-2.</citation>
    <PMID>25030514</PMID>
  </results_reference>
  <results_reference>
    <citation>Osaki M, Miyashita F, Koga M, Fukuda M, Shigehatake Y, Nagatsuka K, Minematsu K, Toyoda K. Simple clinical predictors of stroke outcome based on National Institutes of Health Stroke scale score during 1-h recombinant tissue-type plasminogen activator infusion. Eur J Neurol. 2014 Mar;21(3):411-8. doi: 10.1111/ene.12294. Epub 2013 Nov 7.</citation>
    <PMID>24200315</PMID>
  </results_reference>
  <results_reference>
    <citation>Sakamoto Y, Sato S, Kuronuma Y, Nagatsuka K, Minematsu K, Toyoda K. Factors associated with proximal carotid axis occlusion in patients with acute stroke and atrial fibrillation. J Stroke Cerebrovasc Dis. 2014 May-Jun;23(5):799-804. doi: 10.1016/j.jstrokecerebrovasdis.2013.07.002. Epub 2013 Oct 6.</citation>
    <PMID>24103668</PMID>
  </results_reference>
  <results_reference>
    <citation>Sato S, Uehara T, Hayakawa M, Nagatsuka K, Minematsu K, Toyoda K. Intra- and extracranial atherosclerotic disease in acute spontaneous intracerebral hemorrhage. J Neurol Sci. 2013 Sep 15;332(1-2):116-20. doi: 10.1016/j.jns.2013.06.031. Epub 2013 Jul 13.</citation>
    <PMID>23859180</PMID>
  </results_reference>
  <results_reference>
    <citation>Kobayashi J, Uehara T, Toyoda K, Endo K, Ohara T, Fujinami J, Nagatsuka K, Minematsu K. Clinical significance of fluid-attenuated inversion recovery vascular hyperintensities in transient ischemic attack. Stroke. 2013 Jun;44(6):1635-40. doi: 10.1161/STROKEAHA.111.000787. Epub 2013 May 7.</citation>
    <PMID>23652273</PMID>
  </results_reference>
  <results_reference>
    <citation>Tanaka K, Koga M, Sato K, Suzuki R, Minematsu K, Toyoda K. Three-dimensional analysis of the left atrial appendage for detecting paroxysmal atrial fibrillation in acute ischemic stroke. Int J Stroke. 2014 Dec;9(8):1045-51. doi: 10.1111/ijs.12268. Epub 2014 Mar 13.</citation>
    <PMID>24621380</PMID>
  </results_reference>
  <results_reference>
    <citation>Tomii Y, Toyoda K, Suzuki R, Naganuma M, Fujinami J, Yokota C, Minematsu K. Effects of 24-hour blood pressure and heart rate recorded with ambulatory blood pressure monitoring on recovery from acute ischemic stroke. Stroke. 2011 Dec;42(12):3511-7. doi: 10.1161/STROKEAHA.111.628586. Epub 2011 Sep 29.</citation>
    <PMID>21960578</PMID>
  </results_reference>
  <results_reference>
    <citation>Koga M, Arihiro S, Miyashita F, Yamamoto H, Yamada N, Nagatsuka K, Minematsu K, Toyoda K. Factors associated with early recanalization failure following intravenous rt-PA therapy for ischemic stroke. Cerebrovasc Dis. 2013;36(4):299-305. doi: 10.1159/000355054. Epub 2013 Oct 16.</citation>
    <PMID>24135558</PMID>
  </results_reference>
  <results_reference>
    <citation>Inoue Y, Miyashita F, Koga M, Minematsu K, Toyoda K. Unclear-onset intracerebral hemorrhage: Clinical characteristics, hematoma features, and outcomes. Int J Stroke. 2017 Dec;12(9):961-968. doi: 10.1177/1747493017702664. Epub 2017 Mar 31.</citation>
    <PMID>28361615</PMID>
  </results_reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>April 21, 2020</last_update_submitted>
  <last_update_submitted_qc>April 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cerebral and Cardiovascular Center</investigator_affiliation>
    <investigator_full_name>Kazunori Toyoda</investigator_full_name>
    <investigator_title>Director and Chair, Dept. of Stroke and Cerebrovascular Diseases</investigator_title>
  </responsible_party>
  <keyword>Acute ischemic stroke</keyword>
  <keyword>Acute intracerebral hemorrhage</keyword>
  <keyword>Transient ischemic attack</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT02251665
org study id: NationalCardioCenter
nct id: NCT02251665
lead sponsor: 
has dmc: No
A single-center registry of patients with acute ischemic stroke, intracerebral hemorrhage,
      and transient ischemic attack (TIA) who are emergently managed in the stroke care unit in the
      National Cerebral and Cardiovascular Center (NCVC) to determine change in underlying
      characteristics, stroke features and severity, process for diagnosis and acute treatment, and
      long-term outcomes of stroke/TIA patients over the years.
This is a single-center registry of consecutive patients with acute ischemic stroke,
      intracerebral hemorrhage, and transient ischemic attack (TIA) who are emergently managed in
      the stroke care unit in the National Cerebral and Cardiovascular Center, a flagship stroke
      center in Japan.

      Neurological emergencies other than stroke/TIA and subclinical cerebrobvascular inpatients
      are also enrolled.

      Data are collected and analyzed to determine change in underlying characteristics, stroke
      features and severity, process for diagnosis and acute treatment, and long-term outcomes of
      stroke/TIA patients over the years.

      The National Cerebral and Cardiovascular Center was founded in 1977 in Suita, Osaka, in order
      to provide the public with the most advanced treatment for cardiovascular and cerebrovascular
      diseases and to conduct the highest level of basic as well as applied research on the
      cardiovascular and cerebrovascular systems.
observational model: Case-Only
time perspective: Prospective
measure: The modified Rankin Scale (mRS), a measure of disability
time frame: 3 monhts
description: mRS scores range from 0 (no symptoms at all) to 6 (death)
measure: Number of participants
time frame: at entry
description: Also assessing underlying patients' characteristics prior to index stroke/TIA
measure: National Institutes of Health Stroke Scale score
time frame: at entry
description: Also assessing neurological and cognitive states
measure: Volume of culprit infarcts/hematoma
time frame: at entry
description: ASPECTS on DWI for ischemia or hematoma volume using the ABC/2 method
measure: The modified Rankin Scale (mRS), a measure of disability
time frame: around 3 weeks
description: mRS scores range from 0 (no symptoms at all) to 6 (death). Participants will be followed at hospital discharge, an expected average of 3 weeks.
measure: The modified Rankin Scale (mRS), a measure of disability
time frame: 1 year
description: mRS scores range from 0 (no symptoms at all) to 6 (death)
measure: Events of cardiovascular diseases including stroke/TIA
time frame: around 3 weeks
description: Participants will be followed at hospital discharge, an expected average of 3 weeks.
measure: Events of cardiovascular diseases including stroke/TIA
time frame: 3 months
measure: Events of cardiovascular diseases including stroke/TIA
time frame: 1 year
arm group label: Acute ischemic stroke, acute ICH, TIA
description: Consecutive patients with acute ischemic stroke, intracerebral hemorrhage, and transient ischemic attack who are emergently managed in the stroke care unit or stroke units in the National Cerebral and Cardiovascular Center
intervention type: Other
intervention name: No intervention
description: a single-center prospective observational study
arm group label: Acute ischemic stroke, acute ICH, TIA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Kazunori Toyoda, MD, PhD
role: Principal Investigator
affiliation: Vice Director of the Hospital, National Cerebral and Cardiovascular Center
facility: 
country: Japan
url: http://www.ncvc.go.jp/english/index.html
description: Official home page of the National Cerebral and Cardiovascular Center
citation: Toyoda K, Ninomiya T. Stroke and cerebrovascular diseases in patients with chronic kidney disease. Lancet Neurol. 2014 Aug;13(8):823-33. doi: 10.1016/S1474-4422(14)70026-2.
PMID: 25030514
citation: Osaki M, Miyashita F, Koga M, Fukuda M, Shigehatake Y, Nagatsuka K, Minematsu K, Toyoda K. Simple clinical predictors of stroke outcome based on National Institutes of Health Stroke scale score during 1-h recombinant tissue-type plasminogen activator infusion. Eur J Neurol. 2014 Mar;21(3):411-8. doi: 10.1111/ene.12294. Epub 2013 Nov 7.
PMID: 24200315
citation: Sakamoto Y, Sato S, Kuronuma Y, Nagatsuka K, Minematsu K, Toyoda K. Factors associated with proximal carotid axis occlusion in patients with acute stroke and atrial fibrillation. J Stroke Cerebrovasc Dis. 2014 May-Jun;23(5):799-804. doi: 10.1016/j.jstrokecerebrovasdis.2013.07.002. Epub 2013 Oct 6.
PMID: 24103668
citation: Sato S, Uehara T, Hayakawa M, Nagatsuka K, Minematsu K, Toyoda K. Intra- and extracranial atherosclerotic disease in acute spontaneous intracerebral hemorrhage. J Neurol Sci. 2013 Sep 15;332(1-2):116-20. doi: 10.1016/j.jns.2013.06.031. Epub 2013 Jul 13.
PMID: 23859180
citation: Kobayashi J, Uehara T, Toyoda K, Endo K, Ohara T, Fujinami J, Nagatsuka K, Minematsu K. Clinical significance of fluid-attenuated inversion recovery vascular hyperintensities in transient ischemic attack. Stroke. 2013 Jun;44(6):1635-40. doi: 10.1161/STROKEAHA.111.000787. Epub 2013 May 7.
PMID: 23652273
citation: Tanaka K, Koga M, Sato K, Suzuki R, Minematsu K, Toyoda K. Three-dimensional analysis of the left atrial appendage for detecting paroxysmal atrial fibrillation in acute ischemic stroke. Int J Stroke. 2014 Dec;9(8):1045-51. doi: 10.1111/ijs.12268. Epub 2014 Mar 13.
PMID: 24621380
citation: Tomii Y, Toyoda K, Suzuki R, Naganuma M, Fujinami J, Yokota C, Minematsu K. Effects of 24-hour blood pressure and heart rate recorded with ambulatory blood pressure monitoring on recovery from acute ischemic stroke. Stroke. 2011 Dec;42(12):3511-7. doi: 10.1161/STROKEAHA.111.628586. Epub 2011 Sep 29.
PMID: 21960578
citation: Koga M, Arihiro S, Miyashita F, Yamamoto H, Yamada N, Nagatsuka K, Minematsu K, Toyoda K. Factors associated with early recanalization failure following intravenous rt-PA therapy for ischemic stroke. Cerebrovasc Dis. 2013;36(4):299-305. doi: 10.1159/000355054. Epub 2013 Oct 16.
PMID: 24135558
citation: Inoue Y, Miyashita F, Koga M, Minematsu K, Toyoda K. Unclear-onset intracerebral hemorrhage: Clinical characteristics, hematoma features, and outcomes. Int J Stroke. 2017 Dec;12(9):961-968. doi: 10.1177/1747493017702664. Epub 2017 Mar 31.
PMID: 28361615
responsible party type: Principal Investigator
investigator affiliation: National Cerebral and Cardiovascular Center
investigator full name: Kazunori Toyoda
investigator title: Director and Chair, Dept. of Stroke and Cerebrovascular Diseases
mesh term: Stroke