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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009532
Receipt No. R000011193
Scientific Title Pentraxin 3/sLOX-1 as a markar for early diagnosis of coronary artery abnormality in Kawasaki Disease
Date of disclosure of the study information 2013/01/01
Last modified on 2020/06/18

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Basic information
Public title Pentraxin 3/sLOX-1 as a markar for early diagnosis of coronary artery abnormality in Kawasaki Disease
Acronym PTX3/sLOX-1 in Kawasaki Disease with coronary artery abnormality
Scientific Title Pentraxin 3/sLOX-1 as a markar for early diagnosis of coronary artery abnormality in Kawasaki Disease
Scientific Title:Acronym PTX3/sLOX-1 in Kawasaki Disease with coronary artery abnormality
Region
Japan

Condition
Condition Kawasaki Disease
Classification by specialty
Cardiology Pediatrics Laboratory medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate a clinical significance of PTX3/sLOX-1 as a markar for early diagnosis of coronary artery abnormality in Kawasaki disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes high value of plasma PTX3/sLOX-1 in KD patients with coronary artery abnormality
Key secondary outcomes not high value of plasma PTX3/sLOX-1 in KD patients without coronary artery abnormality at any sample point; onset, before IVIG therapy, after IVIG, near discharge, after discharge.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit
16 years-old >
Gender Male and Female
Key inclusion criteria Suspected of Kawasaki Disease KD
Principal symptoms
1. Fever persisting 5 days or more;
inclusive of cases in whom the fever
has subsided before the fifth day in
response to therapy;
2. Bilateral conjunctival congestion;
3. Changes of lips and oral cavity;
reddening of lips, strawberry tongue,
diffuse injection of oral and haryngeal
mucosa;
4. Polymorphous exanthema;
5. Changes of peripheral extremities;
6. Acute non-purulent cervical
lymphadenopathy.
At least five items of 6 should be satisfied for diagnosis of KD. However, patients with four items of the principal symptoms can be diagnosed with KD when coronary aneurysm or dilatation is recognized by 2-D echocardiography or coronary angiography.
The atypical; incomplete or suspected cases of KD is clincally important since they often develop coronary artery abnormalities. Approximately 10% of the total cases do not fulfil five of the six principal symptoms, in which other diseases can be excluded and KD is suspected. In some of these patients, coronary artery aneurysms have been confirmed. The prevalence of coronary artery abnormalities among those atypical patients was 5.5%.
Key exclusion criteria If Kawasaki Disease has been excluded
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Toshiyuki
Middle name
Last name Kitoh
Organization Aichi Medical University Hospital


Division name Pediatrics
Zip code 480-1195
Address Department of Pediatrics
TEL 0561-62-3311
Email tkitoh@aichi-med-u.ac.jp

Public contact
Name of contact person
1st name Toshiyuki
Middle name
Last name Kitoh
Organization Aichi Medical University Hospital
Division name Pediatrics
Zip code 480-1195
Address 1-1 Yazako Karimata, Nagakute, 480-1195, Japan
TEL 0561-62-3311
Homepage URL
Email tkitoh@aichi-med-u.ac.jp

Sponsor
Institute Ministry of Education
Institute
Department

Funding Source
Organization JSPS KAKENHI Grant Number 16K08422
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Quantitative Biology and Medicine, Research Center for Advanced Science and Technology, the University of Tokyo
Division of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Kobe Gakuin University
Name of secondary funder(s) Toukai Foundation for Technology

IRB Contact (For public release)
Organization Aichi Medical University
Address Department of Pediatrics
Tel +81561623311
Email tkitoh@aichi-med-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 愛知医科大学病院(愛知県)

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 01 Day

Related information
URL releasing protocol https://link.springer.com/content/pdf/10.1007%2Fs00431-017-2979-8.pdf
Publication of results Partially published

Result
URL related to results and publications https://link.springer.com/content/pdf/10.1007%2Fs00431-017-2979-8.pdf
Number of participants that the trial has enrolled 97
Results
In total, 97 cases were registered. 22 case of incomplete KD were excluded from the outcome analysis. 
Results date posted
2020 Year 06 Month 18 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2017 Year 10 Month 01 Day
Baseline Characteristics
Concluded 75 cases:age was betweeen 3 and 114 months; median 27 month,39 male and 26 female
Participant flow
Among the total of 75 cases concluded for statistical analyses, three had CAL and the remaining 72 cases did not (the non-CAL group). 
Adverse events
nothing
Outcome measures
PTX3 on admission in the KD
PTX3 on admission of the patients with coronary artery sequelae
intravenous immunoglobulin (IVIG) resistance
final doses of IVIG to stabilize the disease
freqenncy of KD-related CAL
PTX3 level correlated with the severity of disease
Plan to share IPD nothing
IPD sharing Plan description nothing

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2012 Year 10 Month 26 Day
Date of IRB
2013 Year 01 Month 16 Day
Anticipated trial start date
2013 Year 03 Month 01 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 01 Month 31 Day
Date analysis concluded
2019 Year 08 Month 06 Day

Other
Other related information not open now

Management information
Registered date
2012 Year 12 Month 12 Day
Last modified on
2020 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011193

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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