- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03274869
Scrub Typhus Infection Induced Cardiovascular Disease
February 21, 2024 updated by: Ki-Woon Kang, MD, Eulji University Hospital
Prediction and Early Diagnosis for Cardiovascular Disease Complicated by Scrub Typhus Infection
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ki-Woon Kang, MD., PhD.
- Phone Number: 81 01 4492 2136
- Email: kwkang0115@gmail.com
Study Locations
-
-
Chung Chung Do
-
Chungju, Chung Chung Do, Korea, Republic of, 50122
- Chung-Buk University Hospital
-
Daejeon, Chung Chung Do, Korea, Republic of, 50233
- Chung-Nam University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
Scrub typhus infection without cardiovascular complication Scrub typhus infection with cardiovascular complication
Description
Inclusion Criteria:
- any participants with scrub typhus infection
Exclusion Criteria:
- patients under age of 18
- pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
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
|
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
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiovascular Mortality
Time Frame: one year
|
Cardiovascular death including sudden cardiac death
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiovascular Complications
Time Frame: one year
|
Atrial Fibrillation, Acute Heart Failure including acute myocarditis and Ischemic Heart Dease
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hyu Ryung Cho, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- Kang KW, Hong KW, Lee SK. Identification of novel variants for complicating cardiac disease in the scrub typhus infection using whole genome sequencing. Korean J Intern Med. 2023 Nov;38(6):865-871. doi: 10.3904/kjim.2023.221. Epub 2023 Nov 1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2017
Primary Completion (Actual)
August 30, 2023
Study Completion (Actual)
August 30, 2023
Study Registration Dates
First Submitted
September 3, 2017
First Submitted That Met QC Criteria
September 6, 2017
First Posted (Actual)
September 7, 2017
Study Record Updates
Last Update Posted (Actual)
February 22, 2024
Last Update Submitted That Met QC Criteria
February 21, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMC 2017-07-006-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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