<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/NCT03283306</url>
  </required_header>
  <id_info>
    <org_study_id>B-1607-356-304</org_study_id>
    <nct_id>NCT03283306</nct_id>
  </id_info>
  <brief_title>Prognostic Value of Carotid CEUS in Acute Ischemic Stroke Patients</brief_title>
  <official_title>Prognostic Value of Carotid Contrast-Enhanced Ultrasound in Acute Ischemic Stroke Patients for Cerebrovascular and Cardiovascular Event</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Research Foundation of Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Seoul National University Bundang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Contrast-enhanced ultrasound(CEUS) of carotid artery plaque is a novel method that enabled&#xD;
      direct visualization of neovessels in the vulnerable plaque. Plaque enhancement with CEUS&#xD;
      showed correlation with the histologic density of neovessels within the carotid plaque and&#xD;
      the previous cardiovascular events. Vulnerable plaques with a high risk of thromboembolic&#xD;
      complications and rapid progression is associated with acute ischemic stroke. The prognostic&#xD;
      value of vulnerable carotid artery plaque depicted with CEUS has not been fully investigated.&#xD;
      The purpose of this study is to define prognostic value of plaque enhancement on carotid CEUS&#xD;
      in acute stroke patients. Research question is; in acute ischemic stroke patients with&#xD;
      ipsilateral carotid plaque as probable etiology of stroke, is the presence of carotid plaque&#xD;
      enhancement on CEUS independent predictor of future stroke.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 9, 2017</start_date>
  <completion_date type="Anticipated">September 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Composite of recurrent stroke, vascular death and myocardial infarction</measure>
    <time_frame>12 months</time_frame>
    <description>(1) recurrent stroke: newly appeared DWI positive lesion on brain MRI with corresponding neurologic symptom (2) vascular death: sudden death, death due to stroke, myocardial infarction, heart failure, arrhythmia, pulmonary embolism, systemic bleeding, or ischemia of organ. (3) myocardial infarction: at least two of the followings: ① a history of typical angina pain. ② Elevation of Troponin, ③ Newly developed ST change or Q waves or LBBB on ECG (outcomes will be measured by chart review or physician diagnosis or telephone interview)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ipsilateral stroke</measure>
    <time_frame>12 months</time_frame>
    <description>Recurrent stroke of ipsilateral side (recurrent stroke at same side of previous infarction)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>12 months</time_frame>
    <description>All of the deaths, regardless of the cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Carotid intervention</measure>
    <time_frame>12 months</time_frame>
    <description>Ipsilateral carotid endarterectomy or carotid artery stent insertion which was not planned when discharge.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">667</enrollment>
  <condition>Ultrasonography</condition>
  <condition>Carotid Stenosis</condition>
  <condition>Ischemic Stroke</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitalized acute ischemic stroke patients with ipsilateral carotid artery stenosis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients older than 19 years presenting acute ischemic stroke.&#xD;
&#xD;
          2. Compatible neurologic symptom within 14 days&#xD;
&#xD;
          3. Compatible MRI finding (one or more positive DWI lesions in the territory of&#xD;
             unilateral ICA: ACA or MCA territory) - interpretable MRI image obtained in SNUBH or&#xD;
             outside hospital&#xD;
&#xD;
          4. Etiology of acute ischemic stroke: except cardioembolic stroke (Atrial fibrillation)&#xD;
             and other determined etiology&#xD;
&#xD;
          5. Ipsilateral extracranial carotid artery stenosis on MRA (CE-MRA), CTA or Doppler&#xD;
             ultrasound&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of ipsilateral carotid stent or endarterectomy&#xD;
&#xD;
          2. Carotid intervention during hospital stay&#xD;
&#xD;
          3. Contraindication to ultrasound contrast agent (SonoVue) A. Right to left,&#xD;
             bi-directional, or transient right to left cardiac shunts B. History of&#xD;
             hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or any&#xD;
             ultrasound contrast agent C. Pregnant or lactating woman D. Unstable cardiopulmonary&#xD;
             conditions (acute myocardial infarction, acute coronary artery syndromes, worsening&#xD;
             congestive heart failure, or serious ventricular arrhythmias)&#xD;
&#xD;
          4. Expected life span less than 12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yeo Koon Kim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yeo Koon Kim, MD</last_name>
    <phone>82-10-3460-0660</phone>
    <email>yeokoon@snubh.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Eun Jung Kim</last_name>
    <phone>82-10-2450-3988</phone>
    <email>jfhg92@naver.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yumi Kim</last_name>
      <phone>+82-31-787-8872</phone>
      <email>98716@snubh.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Yeo Koon Kim</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <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>Carotid Stenosis</mesh_term>
    <mesh_term>Ischemia</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/NCT03283306
org study id: B-1607-356-304
nct id: NCT03283306
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Contrast-enhanced ultrasound(CEUS) of carotid artery plaque is a novel method that enabled
      direct visualization of neovessels in the vulnerable plaque. Plaque enhancement with CEUS
      showed correlation with the histologic density of neovessels within the carotid plaque and
      the previous cardiovascular events. Vulnerable plaques with a high risk of thromboembolic
      complications and rapid progression is associated with acute ischemic stroke. The prognostic
      value of vulnerable carotid artery plaque depicted with CEUS has not been fully investigated.
      The purpose of this study is to define prognostic value of plaque enhancement on carotid CEUS
      in acute stroke patients. Research question is; in acute ischemic stroke patients with
      ipsilateral carotid plaque as probable etiology of stroke, is the presence of carotid plaque
      enhancement on CEUS independent predictor of future stroke.
observational model: Cohort
time perspective: Prospective
measure: Composite of recurrent stroke, vascular death and myocardial infarction
time frame: 12 months
description: (1) recurrent stroke: newly appeared DWI positive lesion on brain MRI with corresponding neurologic symptom (2) vascular death: sudden death, death due to stroke, myocardial infarction, heart failure, arrhythmia, pulmonary embolism, systemic bleeding, or ischemia of organ. (3) myocardial infarction: at least two of the followings: ① a history of typical angina pain. ② Elevation of Troponin, ③ Newly developed ST change or Q waves or LBBB on ECG (outcomes will be measured by chart review or physician diagnosis or telephone interview)
measure: Ipsilateral stroke
time frame: 12 months
description: Recurrent stroke of ipsilateral side (recurrent stroke at same side of previous infarction)
measure: All-cause mortality
time frame: 12 months
description: All of the deaths, regardless of the cause
measure: Carotid intervention
time frame: 12 months
description: Ipsilateral carotid endarterectomy or carotid artery stent insertion which was not planned when discharge.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Yeo Koon Kim, MD
role: Principal Investigator
affiliation: Seoul National University Hospital
last name: Yeo Koon Kim, MD
phone: 82-10-3460-0660
email: yeokoon@snubh.org
last name: Eun Jung Kim
phone: 82-10-2450-3988
email: jfhg92@naver.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Yeo Koon Kim
investigator title: Assistant Professor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Cerebral Infarction
mesh term: Carotid Stenosis
mesh term: Ischemia
sharing ipd: Undecided