<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/NCT03274869</url>
  </required_header>
  <id_info>
    <org_study_id>EMC 2017-07-006-001</org_study_id>
    <nct_id>NCT03274869</nct_id>
  </id_info>
  <brief_title>Scrub Typhus Infection Induced Cardiovascular Disease</brief_title>
  <official_title>Prediction and Early Diagnosis for Cardiovascular Disease Complicated by Scrub Typhus Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eulji University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chungnam National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chungbuk National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Eulji University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Scrub typhus infection has been considered as seasonal and endemic infectious disorder with&#xD;
      benign feature. However, the increasing mortality rate of scrub typhus has been recently&#xD;
      reported in Southeast Asia and cause of death could be a fetal complicating cardiovascular&#xD;
      disease. Therefore, the association and predictors for scrub typhus induced cardiovascular&#xD;
      disease should be investigated to provide a timely and appropriate diagnosis and to reduce&#xD;
      the mortality rate of complicated scrub typhus infection. Therefore, investigators&#xD;
      prospectively investigate the association and predictors of cardiovascular disease in the&#xD;
      participants with scrub typhus infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Scrub typhus is a zoonotic disease caused by Orientia tsutsugamushi confined to East Asia&#xD;
      including South Korea. It is characterized by fever, headache, rash, and eschar and the&#xD;
      majority of patients without complications can recover with an early diagnosis and proper&#xD;
      management with antibiotics. However, the increasing mortality rate of scrub typhus has been&#xD;
      recently reported in Southeast Asia. Severe complications can be manifested by respiratory&#xD;
      distress syndrome, renal failure, hepatic failure, and cardiovascular disease. Especially,&#xD;
      cardiovascular complications can lead to cardiogenic shock and sudden cardiac arrest.&#xD;
      Therefore, the association and predictors for scrub typhus induced cardiovascular disease&#xD;
      should be investigated to provide a timely and appropriate diagnosis and to reduce the&#xD;
      mortality rate of complicated scrub typhus infection. Therefore, investigators prospectively&#xD;
      investigate the association and predictors of cardiovascular disease in the participants with&#xD;
      scrub typhus infection admitted to 3rd referral centers in South Korea.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">August 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2023</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>Cardiovascular Mortality</measure>
    <time_frame>one year</time_frame>
    <description>Cardiovascular death including sudden cardiac death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular Complications</measure>
    <time_frame>one year</time_frame>
    <description>Atrial Fibrillation, Acute Heart Failure including acute myocarditis and Ischemic Heart Dease</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Scrub Typhus</condition>
  <condition>Cardiovascular Complication</condition>
  <arm_group>
    <arm_group_label>Scrub typhus without cardiovascular complications</arm_group_label>
    <description>Any participants with the scrub typhus infection without cardiovascular complication will be enrolled as a positive control group during admission and clinically followed by 1 year after discharge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Scrub typhus with cardiovascular complication</arm_group_label>
    <description>Any participants with the scrub typhus infection with cardiovascular complication will be enrolled as a comparison group during admission and clinically followed by 1 year after discharge</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention</description>
    <arm_group_label>Scrub typhus with cardiovascular complication</arm_group_label>
    <arm_group_label>Scrub typhus without cardiovascular complications</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      To find novel genotypes of Orientia tsutsugamushi isolated from Scrub typhus infection&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Scrub typhus infection without cardiovascular complication Scrub typhus infection with&#xD;
        cardiovascular complication&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  any participants with scrub typhus infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients under age of 18&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Hyu Ryung Cho</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chung-Ang University Hosptial, Chung-Ang University College of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ki-Woon Kang, MD., PhD.</last_name>
    <phone>81 01 4492 2136</phone>
    <email>kwkang0115@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chung-Buk University Hospital</name>
      <address>
        <city>Chungju</city>
        <state>Chung Chung Do</state>
        <zip>50122</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dae In Lee, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chung-Nam University Hospital</name>
      <address>
        <city>Daejeon</city>
        <state>Chung Chung Do</state>
        <zip>50233</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jun Hyung Kim, MD. PhD.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Chin JY, Kang KW, Moon KM, Kim J, Choi YJ. Predictors of acute myocarditis in complicated scrub typhus: an endemic province in the Republic of Korea. Korean J Intern Med. 2018 Mar;33(2):323-330. doi: 10.3904/kjim.2016.303. Epub 2017 Feb 23.</citation>
    <PMID>28226202</PMID>
  </reference>
  <reference>
    <citation>Jang SY, Kang KW, Kim JH, Kim B, Chin JY, Park SH, Choi YJ, Jung KT, Lee SK. New-onset atrial fibrillation predicting for complicating cardiac adverse outcome in scrub typhus infection. Clin Cardiol. 2019 Dec;42(12):1210-1221. doi: 10.1002/clc.23276. Epub 2019 Oct 3.</citation>
    <PMID>31580531</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>September 3, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>March 21, 2022</last_update_submitted>
  <last_update_submitted_qc>March 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chung-Ang University Hosptial, Chung-Ang University College of Medicine</investigator_affiliation>
    <investigator_full_name>Ki-Woon Kang, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Scrub typhus</keyword>
  <keyword>Cardiovascular Complication</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Typhus, Epidemic Louse-Borne</mesh_term>
    <mesh_term>Scrub Typhus</mesh_term>
    <mesh_term>Cardiovascular Diseases</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/NCT03274869
org study id: EMC 2017-07-006-001
nct id: NCT03274869
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Scrub typhus infection has been considered as seasonal and endemic infectious disorder with
      benign feature. However, the increasing mortality rate of scrub typhus has been recently
      reported in Southeast Asia and cause of death could be a fetal complicating cardiovascular
      disease. Therefore, the association and predictors for scrub typhus induced cardiovascular
      disease should be investigated to provide a timely and appropriate diagnosis and to reduce
      the mortality rate of complicated scrub typhus infection. Therefore, investigators
      prospectively investigate the association and predictors of cardiovascular disease in the
      participants with scrub typhus infection.
Scrub typhus is a zoonotic disease caused by Orientia tsutsugamushi confined to East Asia
      including South Korea. It is characterized by fever, headache, rash, and eschar and the
      majority of patients without complications can recover with an early diagnosis and proper
      management with antibiotics. However, the increasing mortality rate of scrub typhus has been
      recently reported in Southeast Asia. Severe complications can be manifested by respiratory
      distress syndrome, renal failure, hepatic failure, and cardiovascular disease. Especially,
      cardiovascular complications can lead to cardiogenic shock and sudden cardiac arrest.
      Therefore, the association and predictors for scrub typhus induced cardiovascular disease
      should be investigated to provide a timely and appropriate diagnosis and to reduce the
      mortality rate of complicated scrub typhus infection. Therefore, investigators prospectively
      investigate the association and predictors of cardiovascular disease in the participants with
      scrub typhus infection admitted to 3rd referral centers in South Korea.
observational model: Cohort
time perspective: Prospective
measure: Cardiovascular Mortality
time frame: one year
description: Cardiovascular death including sudden cardiac death
measure: Cardiovascular Complications
time frame: one year
description: Atrial Fibrillation, Acute Heart Failure including acute myocarditis and Ischemic Heart Dease
arm group label: Scrub typhus without cardiovascular complications
description: Any participants with the scrub typhus infection without cardiovascular complication will be enrolled as a positive control group during admission and clinically followed by 1 year after discharge
arm group label: Scrub typhus with cardiovascular complication
description: Any participants with the scrub typhus infection with cardiovascular complication will be enrolled as a comparison group during admission and clinically followed by 1 year after discharge
intervention type: Other
intervention name: No intervention
description: No intervention
arm group label: Scrub typhus with cardiovascular complication
arm group label: Scrub typhus without cardiovascular complications
To find novel genotypes of Orientia tsutsugamushi isolated from Scrub typhus infection
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
last name: Hyu Ryung Cho
role: Principal Investigator
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
last name: Ki-Woon Kang, MD., PhD.
phone: 81 01 4492 2136
email: kwkang0115@gmail.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
citation: Chin JY, Kang KW, Moon KM, Kim J, Choi YJ. Predictors of acute myocarditis in complicated scrub typhus: an endemic province in the Republic of Korea. Korean J Intern Med. 2018 Mar;33(2):323-330. doi: 10.3904/kjim.2016.303. Epub 2017 Feb 23.
PMID: 28226202
citation: Jang SY, Kang KW, Kim JH, Kim B, Chin JY, Park SH, Choi YJ, Jung KT, Lee SK. New-onset atrial fibrillation predicting for complicating cardiac adverse outcome in scrub typhus infection. Clin Cardiol. 2019 Dec;42(12):1210-1221. doi: 10.1002/clc.23276. Epub 2019 Oct 3.
PMID: 31580531
responsible party type: Principal Investigator
investigator affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
investigator full name: Ki-Woon Kang, MD
investigator title: Professor
mesh term: Typhus, Epidemic Louse-Borne
mesh term: Scrub Typhus
mesh term: Cardiovascular Diseases
sharing ipd: Undecided