UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009532
Receipt number 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 2021/06/21 10:05:24

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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 or person

Institute

Ministry of Education

Institute

Department

Personal name



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

Main results already published

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

2021 Year 06 Month 21 Day



Link to view the page

Value
https://center6.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