Scrub Typhus Infection Induced Cardiovascular Disease

• Sponsor: Eulji University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03274869
• Collaborator: Chungnam National University Hospital (Other), Chungbuk National University Hospital (Other)
• Enrollment: 100
• Locations: 2
• Anticipated Duration (Months): 71.9
• Patients Per Site: 50
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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	Phase
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.

Study Design

• Study Type: Observational
• Anticipated 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: Sep 1, 2017
• Anticipated Primary Completion Date: Aug 30, 2023
• Anticipated Study Completion Date: Aug 30, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Cardiovascular Mortality [one year]

   Cardiovascular death including sudden cardiac death

Secondary Outcome Measures

1. Cardiovascular Complications [one year]

   Atrial Fibrillation, Acute Heart Failure including acute myocarditis and Ischemic Heart Dease

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• any participants with scrub typhus infection

Exclusion Criteria:

• patients under age of 18

• pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chung-Buk University Hospital	Chungju	Chung Chung Do	Korea, Republic of	50122
2	Chung-Nam University Hospital	Daejeon	Chung Chung Do	Korea, Republic of	50233

Sponsors and Collaborators

• Eulji University Hospital
• Chungnam National University Hospital
• Chungbuk National University Hospital

Investigators

• Principal Investigator: Hyu Ryung Cho, Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Ki-Woon Kang, MD, Professor, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
• ClinicalTrials.gov Identifier: NCT03274869
• Other Study ID Numbers: EMC 2017-07-006-001
• First Posted: Sep 7, 2017
• Last Update Posted: Apr 1, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ki-Woon Kang, MD, Professor, Chung-Ang University Hosptial, Chung-Ang University College of Medicine: Scrub typhus; Cardiovascular Complication
• Additional relevant MeSH terms: Typhus, Epidemic Louse-Borne; Scrub Typhus; Cardiovascular Diseases

Study Results

No Results Posted as of Apr 1, 2022