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Scrub Typhus Infection Induced Cardiovascular Disease

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ClinicalTrials.gov Identifier: NCT03274869
Recruitment Status : Recruiting
First Posted : September 7, 2017
Last Update Posted : October 9, 2019
Sponsor:
Collaborators:
Chungnam National University Hospital
Chungbuk National University Hospital
Information provided by (Responsible Party):
Ki-Woon Kang, Eulji University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Scrub Typhus Cardiovascular Complication Other: No intervention

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction and Early Diagnosis for Cardiovascular Disease Complicated by Scrub Typhus Infection
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Scrub typhus without cardiovascular complications
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
Other: No intervention
No intervention

Scrub typhus with cardiovascular complication
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
Other: No intervention
No intervention




Primary Outcome Measures :
  1. Cardiovascular Mortality [ Time Frame: one year ]
    Cardiovascular death including sudden cardiac death


Secondary Outcome Measures :
  1. Cardiovascular Complications [ Time Frame: one year ]
    Atrial Fibrillation, Acute Heart Failure including acute myocarditis and Ischemic Heart Dease


Biospecimen Retention:   Samples With DNA
To find novel genotypes of Orientia tsutsugamushi isolated from Scrub typhus infection


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Scrub typhus infection without cardiovascular complication Scrub typhus infection with cardiovascular complication
Criteria

Inclusion Criteria:

  • any participants with scrub typhus infection

Exclusion Criteria:

  • patients under age of 18
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274869


Contacts
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Contact: Ki-Woon Kang, MD., PhD. 81 42 611 3081 kwkang@eulji.ac.kr

Locations
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Korea, Republic of
Chung-Buk University Hospital Recruiting
Chungju, Chung Chung Do, Korea, Republic of, 50122
Contact: Dae In Lee, MD         
Chung-Nam University Hospital Recruiting
Daejeon, Chung Chung Do, Korea, Republic of, 50233
Contact: Jun Hyung Kim, MD. PhD.         
Sponsors and Collaborators
Eulji University Hospital
Chungnam National University Hospital
Chungbuk National University Hospital
Investigators
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Principal Investigator: Hyu Ryung Cho Eulji University Hospital

Publications:
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Responsible Party: Ki-Woon Kang, Professor, Eulji University Hospital
ClinicalTrials.gov Identifier: NCT03274869     History of Changes
Other Study ID Numbers: EMC 2017-07-006-001
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ki-Woon Kang, Eulji University Hospital:
Scrub typhus
Cardiovascular Complication
Additional relevant MeSH terms:
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Typhus, Epidemic Louse-Borne
Scrub Typhus
Cardiovascular Diseases
Rickettsia Infections
Rickettsiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections