<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/NCT03291652</url>
  </required_header>
  <id_info>
    <org_study_id>crec no. 2011.021</org_study_id>
    <nct_id>NCT03291652</nct_id>
  </id_info>
  <brief_title>Morphology of Advanced Symptomatic Cerebral Plaques With High Embolic Potential</brief_title>
  <official_title>Morphology of Advanced Symptomatic Cerebral Plaques With High Embolic Potential</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</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>
      The study is to attain early recognition of the unstable plaques which have an imminent&#xD;
      embolic risk in patients with intracranial atherosclerotic disease (IAD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Potential candidates will undergo a cranial MRI and MR angiography. Patients who are found&#xD;
      signal void in a relevant intracranial internal carotid artery or middle cerebral artery will&#xD;
      proceed to a 30-minute TCD monitoring for MES an angiograms will be analyzed by investigators&#xD;
      blind to subjects' clinical information. All recruited patients will receive standard medical&#xD;
      therapy throughout the investigation period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 2010</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 23, 2023</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>The plaque morphology of high-risk IAD may be distinct from the silent ones.</measure>
    <time_frame>Dec, 2020</time_frame>
    <description>The morphological attributes (surface outline, angulations and plaque volume) and collateral grading will be compared between symptomatic and asymptomatic group.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Ischemic Stroke</condition>
  <condition>Atheroscleroses, Cerebral</condition>
  <arm_group>
    <arm_group_label>Symptomatic stroke patient</arm_group_label>
    <description>DSA and 3DRA will be performed with access through a 4F sheath at the right femoral artery. Angiograms of intracranial arteries will be obtained by contrast injection at internal carotid artery and vertebral artery ostium from a 4F H1 catheter. Each injection will contain 10ml of iopaminro 300 diluted in 1:1 with normal saline. Each angiographic run will capture a complete series of images from the arterial phase to the end of the venous phase. A 3-dimensional rotational angiogram (a scan time of 4 seconds with 120 images) will be obtained for evaluation of plaque morphology.&#xD;
2. The access site will be closely observed for hemostasis after the procedure. The neurological status and renal function will be monitored.&#xD;
Diagnosis procedure: DSA/3DRA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Asymptomatic stroke patient</arm_group_label>
    <description>DSA and 3DRA will be performed with access through a 4F sheath at the right femoral artery. Angiograms of intracranial arteries will be obtained by contrast injection at internal carotid artery and vertebral artery ostium from a 4F H1 catheter. Each injection will contain 10ml of iopaminro 300 diluted in 1:1 with normal saline. Each angiographic run will capture a complete series of images from the arterial phase to the end of the venous phase. A 3-dimensional rotational angiogram (a scan time of 4 seconds with 120 images) will be obtained for evaluation of plaque morphology.&#xD;
2. The access site will be closely observed for hemostasis after the procedure. The neurological status and renal function will be monitored.&#xD;
Diagnosis procedure: DSA/3DRA</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>DSA/3DRA</intervention_name>
    <description>DSA/3DRA</description>
    <arm_group_label>Asymptomatic stroke patient</arm_group_label>
    <arm_group_label>Symptomatic stroke patient</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who admitted to Prince of Wales Hospital for acute stroke will be screened for&#xD;
        eligibility.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion Criteria for the Symptomatic Group:&#xD;
&#xD;
               1. Patient is 30 to 85 years of age, inclusive.&#xD;
&#xD;
               2. Patients who have an acute infarct in diffusion-weighted MRI compatible with&#xD;
                  artery-to-artery thrombo-embolism, a relevant intracranial atherosclerotic&#xD;
                  stenosis ≥60%, and MES detected by TCD.&#xD;
&#xD;
               3. Patient who has no contra-indication for the proposed imaging tests.&#xD;
&#xD;
               4. Patient understands the purpose and requirements of the study, and has provided&#xD;
                  an informed consent.&#xD;
&#xD;
          -  Inclusion Criteria for the Asymptomatic Group:&#xD;
&#xD;
               1. Patient is 30 to 85 years of age, inclusive.&#xD;
&#xD;
               2. Patient who has a high-grade (&gt;60%) intracranial stenosis (signal void in MR&#xD;
                  angiography) but without infarct in the corresponding vascular territory in DWI&#xD;
                  or T2-weighted sequence.&#xD;
&#xD;
               3. Patient has no MES detected on TCD examination.&#xD;
&#xD;
               4. Patient who has no contra-indication for the proposed imaging tests.&#xD;
&#xD;
               5. Patient understands the purpose and requirements of the study, and has provided&#xD;
                  an informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subject who meets one or more of the following criteria cannot be recruited in the study:&#xD;
&#xD;
          1. Stroke etiology uncertain or unrelated to intracranial atherosclerosis, such as&#xD;
             cardioembolism, Moyamoya disease, small vessel disease, etc.&#xD;
&#xD;
          2. A tandem stenosis &gt;50% at proximal internal carotid artery.&#xD;
&#xD;
          3. Bleeding propensity: active peptic ulcer disease, major systemic hemorrhage within 30&#xD;
             days, thrombocytopenia (platelets &lt;100 x 109/L), coagulopathy (INR &gt;1.5).&#xD;
&#xD;
          4. A medical condition that would not allow the patient to adhere to the protocol or&#xD;
             complete the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Wai Hong LEUNG, FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Thomas Wai Hong LEUNG, FRCP</last_name>
    <phone>852-35053593</phone>
    <email>drtleung@cuhk.edu.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chinese University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Wai Hong LEUNG, FRCP</last_name>
      <phone>852-35053593</phone>
      <email>drtleung@cuhk.edu.hk</email>
    </contact>
    <contact_backup>
      <last_name>Tiffany CHUNG, M.Phil</last_name>
      <phone>852-35053856</phone>
      <email>tiffanyc@cuhk.edu.hk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>May 5, 2023</last_update_submitted>
  <last_update_submitted_qc>May 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Leung Wai Hong Thomas</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Ischemic Stroke</keyword>
  <keyword>atherosclerosis</keyword>
  <keyword>Plaque morphology</keyword>
  <keyword>DSA/3DRA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Intracranial Arteriosclerosis</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03291652
org study id: crec no. 2011.021
nct id: NCT03291652
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is to attain early recognition of the unstable plaques which have an imminent
      embolic risk in patients with intracranial atherosclerotic disease (IAD).
Potential candidates will undergo a cranial MRI and MR angiography. Patients who are found
      signal void in a relevant intracranial internal carotid artery or middle cerebral artery will
      proceed to a 30-minute TCD monitoring for MES an angiograms will be analyzed by investigators
      blind to subjects' clinical information. All recruited patients will receive standard medical
      therapy throughout the investigation period.
observational model: Case-Control
time perspective: Prospective
measure: The plaque morphology of high-risk IAD may be distinct from the silent ones.
time frame: Dec, 2020
description: The morphological attributes (surface outline, angulations and plaque volume) and collateral grading will be compared between symptomatic and asymptomatic group.
arm group label: Symptomatic stroke patient
description: DSA and 3DRA will be performed with access through a 4F sheath at the right femoral artery. Angiograms of intracranial arteries will be obtained by contrast injection at internal carotid artery and vertebral artery ostium from a 4F H1 catheter. Each injection will contain 10ml of iopaminro 300 diluted in 1:1 with normal saline. Each angiographic run will capture a complete series of images from the arterial phase to the end of the venous phase. A 3-dimensional rotational angiogram (a scan time of 4 seconds with 120 images) will be obtained for evaluation of plaque morphology.
2. The access site will be closely observed for hemostasis after the procedure. The neurological status and renal function will be monitored.
Diagnosis procedure: DSA/3DRA
arm group label: Asymptomatic stroke patient
description: DSA and 3DRA will be performed with access through a 4F sheath at the right femoral artery. Angiograms of intracranial arteries will be obtained by contrast injection at internal carotid artery and vertebral artery ostium from a 4F H1 catheter. Each injection will contain 10ml of iopaminro 300 diluted in 1:1 with normal saline. Each angiographic run will capture a complete series of images from the arterial phase to the end of the venous phase. A 3-dimensional rotational angiogram (a scan time of 4 seconds with 120 images) will be obtained for evaluation of plaque morphology.
2. The access site will be closely observed for hemostasis after the procedure. The neurological status and renal function will be monitored.
Diagnosis procedure: DSA/3DRA
intervention type: Diagnostic Test
intervention name: DSA/3DRA
description: DSA/3DRA
arm group label: Asymptomatic stroke patient
arm group label: Symptomatic stroke patient
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: 85 Years
healthy volunteers: No
last name: Thomas Wai Hong LEUNG, FRCP
role: Principal Investigator
affiliation: Chinese University of Hong Kong
last name: Thomas Wai Hong LEUNG, FRCP
phone: 852-35053593
email: drtleung@cuhk.edu.hk
facility: 
status: Recruiting
contact: 
contact backup: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Leung Wai Hong Thomas
investigator title: Professor
mesh term: Ischemic Stroke
mesh term: Intracranial Arteriosclerosis
mesh term: Atherosclerosis
sharing ipd: No