Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-14 @ 5:49 AM
Study NCT ID:
NCT03274869
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-24
First Post:
2017-09-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Scrub Typhus Infection Induced Cardiovascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012612', 'term': 'Scrub Typhus'}], 'ancestors': [{'id': 'D012288', 'term': 'Rickettsiaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'To find novel genotypes of Orientia tsutsugamushi isolated from Scrub typhus infection'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-20', 'studyFirstSubmitDate': '2017-09-03', 'studyFirstSubmitQcDate': '2017-09-06', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular Mortality', 'timeFrame': 'one year', 'description': 'Cardiovascular death including sudden cardiac death'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular Complications', 'timeFrame': 'one year', 'description': 'Atrial Fibrillation, Acute Heart Failure including acute myocarditis and Ischemic Heart Dease'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Scrub typhus', 'Cardiovascular Complication'], 'conditions': ['Scrub Typhus', 'Cardiovascular Complication']}, 'referencesModule': {'references': [{'pmid': '28226202', 'type': 'RESULT', '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': '31580531', 'type': 'RESULT', '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': '37939667', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Scrub typhus infection without cardiovascular complication Scrub typhus infection with cardiovascular complication', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* any participants with scrub typhus infection\n\nExclusion Criteria:\n\n* patients under age of 18\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT03274869', 'briefTitle': 'Scrub Typhus Infection Induced Cardiovascular Disease', 'organization': {'class': 'OTHER', 'fullName': 'Eulji University Hospital'}, 'officialTitle': 'Prediction and Early Diagnosis for Cardiovascular Disease Complicated by Scrub Typhus Infection', 'orgStudyIdInfo': {'id': 'EMC 2017-07-006-001'}}, 'armsInterventionsModule': {'armGroups': [{'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'}, {'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'}]}, 'contactsLocationsModule': {'locations': [{'zip': '50122', 'city': 'Chungju', 'state': 'Chung Chung Do', 'country': 'South Korea', 'facility': 'Chung-Buk University Hospital', 'geoPoint': {'lat': 36.97666, 'lon': 127.9287}}, {'zip': '50233', 'city': 'Daejeon', 'state': 'Chung Chung Do', 'country': 'South Korea', 'facility': 'Chung-Nam University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}], 'overallOfficials': [{'name': 'Hyu Ryung Cho', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eulji University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine', 'class': 'OTHER'}, {'name': 'Chungbuk National University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ki-Woon Kang, MD', 'investigatorAffiliation': 'Eulji University Hospital'}}}}