<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/NCT03295773</url>
  </required_header>
  <id_info>
    <org_study_id>crec no. 2015.623</org_study_id>
    <nct_id>NCT03295773</nct_id>
  </id_info>
  <brief_title>Morphologic Evolution and Remodeling of Intracranial Atherosclerosis: A Longitudinal Study by 3D-rotational Angiography</brief_title>
  <official_title>Morphologic Evolution and Remodeling of Intracranial Atherosclerosis: A Longitudinal Study by 3D-rotational Angiography</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>
      This study is to elucidate the morphologic evolution and remodeling of ICAD under stringent&#xD;
      control of cardiovascular risk factors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigator has conducted extensive research on ICAD by transcranial Doppler ultrasound,&#xD;
      CT angiography and perfusion studies, magnetic resonance imaging (MRI) and digital&#xD;
      subtraction angiography (DSA) respectively. Currently, the investigator applied 3-dimensional&#xD;
      rotational angiogram (3DRA), a selective intra-arterial catheter-based imaging technique that&#xD;
      had a superior spatial resolution compared with CT, MRI or DSA in depicting minute (&lt;3mm)&#xD;
      angio-architecture. Through 3DRA, the investigator could appreciate the ICAD patho-anatomy&#xD;
      from a near-infinite number of planes, analyzing the stroke mechanisms and morphological&#xD;
      changes with much improved precision. A neuro-radiologist and a stroke neurologist blind to&#xD;
      time sequence will measure the geometric parameters and the luminal narrowing by WASID&#xD;
      method.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 22, 2016</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 28, 2023</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>Morphologic Evolution and Remodeling of Intracranial Atherosclerosis</measure>
    <time_frame>Dec, 2019</time_frame>
    <description>The 3DRA images (the disparity in morphological attributes, including surface outline, angulations, plaque volume and distribution) of the patients in pre and post 12 month follow-up would be compared.</description>
  </primary_outcome>
  <number_of_groups>1</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>Patients who are found signal void in a relevant intracranial internal carotid artery or middle cerebral artery (stenosis &gt;60%) will proceed to a 3-Dimensional rotational angiography (3DRA) at baseline and in 12 months. All recruited patients will receive dual antiplatelet agents for 4 weeks, followed by aspirin alone. The investigator or neurologists shall regularly review the patients and treat the conventional cardiovascular risk factors based on four pre-specified goals, for example, LDL &lt;1.8, HbA1c &lt;6.0, blood pressure &lt;140/90 and no smoking. The morphologic changes of the cerebral plaques with the intensity of the risk factor control in pre and post will be correlated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>3DRA</intervention_name>
    <arm_group_label>Symptomatic stroke patient</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have acute cerebral ischemic symptoms attributed to a high-grade (≥60%)&#xD;
        stenosis at a middle cerebral artery or intracranial segment of an internal carotid artery&#xD;
        (ICA) would be reviewed by neurologists. If their stroke etiology and relevance to ICAD&#xD;
        based on clinical syndrome, vascular imaging features and concurrent cardiovascular risks&#xD;
        are eligible, they would be invited to join the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#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 and a relevant intracranial atherosclerotic stenosis&#xD;
             ≥60%.&#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 an&#xD;
             informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patient with any of the following conditions would be excluded:&#xD;
&#xD;
          1. Stroke etiology uncertain or unrelated to intracranial atherosclerosis, such as&#xD;
             cardioembolism, Moyamoya disease, small vessel disease or primary angiitis of CNS.&#xD;
&#xD;
          2. A tandem stenosis &gt;50% at extra-cranial 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>18 Years</minimum_age>
    <maximum_age>80 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>852-35053846</phone>
      <email>drtleung@cuhk.edu.hk</email>
    </contact>
    <contact_backup>
      <last_name>Tiffany CHUNG</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 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 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>3D-rotational angiography</keyword>
  <keyword>Morphology</keyword>
  <keyword>Atherosclerosis</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/NCT03295773
org study id: crec no. 2015.623
nct id: NCT03295773
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is to elucidate the morphologic evolution and remodeling of ICAD under stringent
      control of cardiovascular risk factors.
The investigator has conducted extensive research on ICAD by transcranial Doppler ultrasound,
      CT angiography and perfusion studies, magnetic resonance imaging (MRI) and digital
      subtraction angiography (DSA) respectively. Currently, the investigator applied 3-dimensional
      rotational angiogram (3DRA), a selective intra-arterial catheter-based imaging technique that
      had a superior spatial resolution compared with CT, MRI or DSA in depicting minute (<3mm)
      angio-architecture. Through 3DRA, the investigator could appreciate the ICAD patho-anatomy
      from a near-infinite number of planes, analyzing the stroke mechanisms and morphological
      changes with much improved precision. A neuro-radiologist and a stroke neurologist blind to
      time sequence will measure the geometric parameters and the luminal narrowing by WASID
      method.
observational model: Case-Only
time perspective: Prospective
measure: Morphologic Evolution and Remodeling of Intracranial Atherosclerosis
time frame: Dec, 2019
description: The 3DRA images (the disparity in morphological attributes, including surface outline, angulations, plaque volume and distribution) of the patients in pre and post 12 month follow-up would be compared.
arm group label: Symptomatic stroke patient
description: Patients who are found signal void in a relevant intracranial internal carotid artery or middle cerebral artery (stenosis >60%) will proceed to a 3-Dimensional rotational angiography (3DRA) at baseline and in 12 months. All recruited patients will receive dual antiplatelet agents for 4 weeks, followed by aspirin alone. The investigator or neurologists shall regularly review the patients and treat the conventional cardiovascular risk factors based on four pre-specified goals, for example, LDL <1.8, HbA1c <6.0, blood pressure <140/90 and no smoking. The morphologic changes of the cerebral plaques with the intensity of the risk factor control in pre and post will be correlated.
intervention type: Diagnostic Test
intervention name: 3DRA
arm group label: Symptomatic stroke patient
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 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