<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/NCT03821571</url>
  </required_header>
  <id_info>
    <org_study_id>201811039RIND</org_study_id>
    <nct_id>NCT03821571</nct_id>
  </id_info>
  <brief_title>Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism</brief_title>
  <official_title>Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan 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>
      Hypertension is known to be the major risk factor for stroke. The most common cause of&#xD;
      secondary hypertension, primary aldosteronism (PA), is characterized by the excessive&#xD;
      secretion of aldosterone and is related to hypertension and hypokalemia. PA accounts for 3-10&#xD;
      % of hypertensive patients, and a higher incidence of vascular complications compared to&#xD;
      patients with essential hypertension was observed in several studies. The vascular injury&#xD;
      from excessive aldosterone can occur via oxidative stress and collagen remodeling, causing&#xD;
      endothelial dysfunction and fibrosis in the vasculature.&#xD;
&#xD;
      The association between cerebral small vessel disease (cSVD) and hypertension has been well&#xD;
      studies in the past decades. However, not much study has focused on the cSVD burden in&#xD;
      patient with PA. The goal of this study is to understand the features of cSVD in patients&#xD;
      with PA and for the purpose of understanding the underlying pathophysiology of&#xD;
      cerebrovascular injury in this particular patient group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 25, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cerebrovascular reactivity</measure>
    <time_frame>During the brain MRI</time_frame>
    <description>Cerebrovascular reactivity measured by MRI under primary aldosteronism</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism</condition>
  <arm_group>
    <arm_group_label>Patient with primary aldosteronism</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Brain MRI with T1WI, T2WI, FLAIR, thin-sliced T1WI, DWI, TOF, and blood sensitive sequence (SWI) will be performed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient with essential hypertension</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Brain MRI with T1WI, T2WI, FLAIR, thin-sliced T1WI, DWI, TOF, and blood sensitive sequence (SWI) will be performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Brain MRI</intervention_name>
    <description>Brain MRI with blood sensitive sequence (SWI) will be performed to all enrolled patients.</description>
    <arm_group_label>Patient with essential hypertension</arm_group_label>
    <arm_group_label>Patient with primary aldosteronism</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 20-90 years-old&#xD;
&#xD;
          -  patient with primary aldosteronism or healthy control&#xD;
&#xD;
          -  consciousness clear&#xD;
&#xD;
          -  willing to receive brain MRI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  renal failure or Creatinine &gt; 2mg/dl&#xD;
&#xD;
          -  coagulopathy or hepatic insufficiency&#xD;
&#xD;
          -  unstable vital sign under inotropic agents&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  metal implant or cardiac pacemaker&#xD;
&#xD;
          -  major brain surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hsin-Hsi Tsai, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bei-Hu branch, National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hsin-Hsi Tsai</last_name>
    <phone>+886 939916897</phone>
    <email>tsaihsinhsi@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Bo-Ching Lee, MD</last_name>
    <phone>+886 972653442</phone>
    <email>bochinglee@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Bei-Hu Branch, National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>10048</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <contact>
      <last_name>Hsin-Hsi Tsai, MD</last_name>
      <phone>+886 939916897</phone>
      <email>tsaihsinhsi@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hypertension,primary aldosteronism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Small Vessel Diseases</mesh_term>
    <mesh_term>Hyperaldosteronism</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/NCT03821571
org study id: 201811039RIND
nct id: NCT03821571
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hypertension is known to be the major risk factor for stroke. The most common cause of
      secondary hypertension, primary aldosteronism (PA), is characterized by the excessive
      secretion of aldosterone and is related to hypertension and hypokalemia. PA accounts for 3-10
      % of hypertensive patients, and a higher incidence of vascular complications compared to
      patients with essential hypertension was observed in several studies. The vascular injury
      from excessive aldosterone can occur via oxidative stress and collagen remodeling, causing
      endothelial dysfunction and fibrosis in the vasculature.

      The association between cerebral small vessel disease (cSVD) and hypertension has been well
      studies in the past decades. However, not much study has focused on the cSVD burden in
      patient with PA. The goal of this study is to understand the features of cSVD in patients
      with PA and for the purpose of understanding the underlying pathophysiology of
      cerebrovascular injury in this particular patient group.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Cerebrovascular reactivity
time frame: During the brain MRI
description: Cerebrovascular reactivity measured by MRI under primary aldosteronism
arm group label: Patient with primary aldosteronism
arm group type: Experimental
description: Brain MRI with T1WI, T2WI, FLAIR, thin-sliced T1WI, DWI, TOF, and blood sensitive sequence (SWI) will be performed.
arm group label: Patient with essential hypertension
arm group type: Active Comparator
description: Brain MRI with T1WI, T2WI, FLAIR, thin-sliced T1WI, DWI, TOF, and blood sensitive sequence (SWI) will be performed.
intervention type: Diagnostic Test
intervention name: Brain MRI
description: Brain MRI with blood sensitive sequence (SWI) will be performed to all enrolled patients.
arm group label: Patient with essential hypertension
arm group label: Patient with primary aldosteronism
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hsin-Hsi Tsai, MD
role: Principal Investigator
affiliation: Bei-Hu branch, National Taiwan University Hospital
last name: Hsin-Hsi Tsai
phone: +886 939916897
email: tsaihsinhsi@gmail.com
last name: Bo-Ching Lee, MD
phone: +886 972653442
email: bochinglee@gmail.com
facility: 
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Cerebral Small Vessel Diseases
mesh term: Hyperaldosteronism