<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/NCT03789357</url>
  </required_header>
  <id_info>
    <org_study_id>PA_CVA</org_study_id>
    <nct_id>NCT03789357</nct_id>
  </id_info>
  <brief_title>Prevalence of Primary Aldosteronism in Patients With Stroke</brief_title>
  <official_title>Prevalence of Primary Aldosteronism in Patients With Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changi General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Changi General 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>
      Strokes leads to significant morbidity and mortality, and hypertension is the most important&#xD;
      risk factor for strokes. It is estimated that up to 10% of patients with hypertension have&#xD;
      the underlying, treatable condition of primary aldosteronism. Hence, we hypothesize that the&#xD;
      prevalence of primary aldosteronism is high in patients with strokes, a complication of&#xD;
      long-standing hypertension.&#xD;
&#xD;
      Patients admitted with an acute stroke to the Acute Stroke Unit, Changi General Hospital,&#xD;
      will be screened for Primary Aldosteronism three months post-stroke, and confirmatory tests&#xD;
      will be done with saline-infusion test.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">September 30, 2021</completion_date>
  <primary_completion_date type="Actual">July 31, 2021</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Percentage of patients with stroke with confirmed primary aldosteronism in patients admitted to the acute stroke unit for stroke</measure>
    <time_frame>6 months</time_frame>
    <description>Percentage of patients with confirmed Primary Aldosteronism using confirmatory test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Accuracy of Screening test in early period post-stroke</measure>
    <time_frame>3 months</time_frame>
    <description>To determine if the screening blood test for primary aldosteronism performed within 1 week post-stroke is equally accurate compared to being performed 2-4 months post-stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of unilateral primary aldosteronism in patients admitted with acute stroke</measure>
    <time_frame>6 months</time_frame>
    <description>Percentage of unilateral PA amongst patients with stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with positive screening test in patients admitted with acute stroke</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure change after treatment for primary aldosteronism</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac Complications</measure>
    <time_frame>6 months</time_frame>
    <description>Cardiac complications in patients with primary aldosteronism, compared to those without primary aldosteronism, as assessed by transthoracic echocardiography features of left ventricular hypertrophy / mass, and diastolic dysfunction</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Primary Aldosteronism</condition>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Single Arm</arm_group_label>
    <description>All patients admitted to the Acute Stroke Unit</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Aldosterone renin ratio</intervention_name>
    <description>Aldosterone Renin Ratio to screen for Primary Aldosteronism</description>
    <arm_group_label>Single Arm</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Prospective study to evaluate the prevalence of primary aldosteronism in patients with an&#xD;
        acute stroke. 300 patients admitted with CVA/TIA will be enrolled into the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 21-80 years&#xD;
&#xD;
          2. Admitted with acute cerebrovascular accident (CVA) or transient ischemic attack (TIA)&#xD;
             to the ASU, CGH&#xD;
&#xD;
          3. Patients with both ischemic and hemorrhagic strokes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        a. Pregnant patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Troy Puar, MRCP UK</last_name>
    <role>Principal Investigator</role>
    <affiliation>Changi General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Changi General Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>529889</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>May 19, 2022</last_update_submitted>
  <last_update_submitted_qc>May 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <keyword>Arrhythmia</keyword>
  <keyword>Adrenal vein sampling</keyword>
  <keyword>Mineralocorticoid-receptor Antagonists</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Hyperaldosteronism</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/NCT03789357
org study id: PA_CVA
nct id: NCT03789357
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Strokes leads to significant morbidity and mortality, and hypertension is the most important
      risk factor for strokes. It is estimated that up to 10% of patients with hypertension have
      the underlying, treatable condition of primary aldosteronism. Hence, we hypothesize that the
      prevalence of primary aldosteronism is high in patients with strokes, a complication of
      long-standing hypertension.

      Patients admitted with an acute stroke to the Acute Stroke Unit, Changi General Hospital,
      will be screened for Primary Aldosteronism three months post-stroke, and confirmatory tests
      will be done with saline-infusion test.
observational model: Cohort
time perspective: Prospective
measure: Percentage of patients with stroke with confirmed primary aldosteronism in patients admitted to the acute stroke unit for stroke
time frame: 6 months
description: Percentage of patients with confirmed Primary Aldosteronism using confirmatory test
measure: Accuracy of Screening test in early period post-stroke
time frame: 3 months
description: To determine if the screening blood test for primary aldosteronism performed within 1 week post-stroke is equally accurate compared to being performed 2-4 months post-stroke.
measure: Percentage of unilateral primary aldosteronism in patients admitted with acute stroke
time frame: 6 months
description: Percentage of unilateral PA amongst patients with stroke
measure: Percentage of patients with positive screening test in patients admitted with acute stroke
time frame: 3 months
measure: Blood pressure change after treatment for primary aldosteronism
time frame: 12 months
measure: Cardiac Complications
time frame: 6 months
description: Cardiac complications in patients with primary aldosteronism, compared to those without primary aldosteronism, as assessed by transthoracic echocardiography features of left ventricular hypertrophy / mass, and diastolic dysfunction
arm group label: Single Arm
description: All patients admitted to the Acute Stroke Unit
intervention type: Diagnostic Test
intervention name: Aldosterone renin ratio
description: Aldosterone Renin Ratio to screen for Primary Aldosteronism
arm group label: Single Arm
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
last name: Troy Puar, MRCP UK
role: Principal Investigator
affiliation: Changi General Hospital
facility: 
country: Singapore
responsible party type: Sponsor
mesh term: Stroke
mesh term: Hyperaldosteronism
sharing ipd: No