UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028755 |
|---|---|
| Receipt number | R000032905 |
| Scientific Title | Surveillance of the current follow-up status of the adult Kawasaki disease patients with giant coronary aneurysm |
| Date of disclosure of the study information | 2017/08/21 |
| Last modified on | 2019/09/01 19:40:59 |
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Basic information
Public title
Surveillance of the current follow-up status of the adult Kawasaki disease patients with giant coronary aneurysm
Acronym
Follow-up status of adult Kawasaki disease patients
Scientific Title
Surveillance of the current follow-up status of the adult Kawasaki disease patients with giant coronary aneurysm
Scientific Title:Acronym
Follow-up status of adult Kawasaki disease patients
Region
| Japan |
Condition
Condition
Giant coronary aneurysm associated with Kawasaki disease
Classification by specialty
| Cardiology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Surveillance on the follow-up status of adult Kawasaki disease patients associated with giant coronary aneurysm in Japan and analysis of dropout cases
Basic objectives2
Others
Basic objectives -Others
Surveillance on the current follow-up status of adult Kawasaki disease patients
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dropout, Non-dropout
Key secondary outcomes
Gender, Frequency of changing hospital, Cardiac artery lesions, Cardiac ischemia, Surgical/cathetel Intervention, Oral medicine
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Kawasaki disease patients with giant aneurysm reported in 12th -14th nation-wide survey (1991-1996) for KD patients in Japan
Key exclusion criteria
Cases who do not coincide with the definition of adult Kawasaki disease patients (older than 20year-old) with giant aneurysm (larger than 8mm on diameter)
Cases who are considered inappropriate for this study by the principal investigator
Target sample size
351
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Tamai |
Organization
Osaka Medical College hospital
Division name
Department of Pediatrics
Zip code
569-8686
Address
2-7, Daigakumachi, Takatsuki, Osaka, Japan
TEL
072-683-1221
ped100@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Katayama |
Organization
Osaka Medical College hospital
Division name
Department of Pediatrics
Zip code
569-8686
Address
2-7, Daigakumachi, Takatsuki, Osaka, Japan
TEL
072-683-1221
Homepage URL
http://www.osaka-med.ac.jp/deps/ped/
ped100@osaka-med.ac.jp
Sponsor or person
Institute
Research group for surveillance of the current follow-up status of the adult Kawasaki disease patients with giant coronary aneurysm
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Kawasaki Disease
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical College, Department of Pediatrics
Address
2-7, Daigaku-machi, Takatsuki, Osaka, Japan
Tel
0726831221
ped100@osaka-med.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
大阪医科大学附属病院（大阪府） Osaka Medical College hospital (Osaka)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 21 | Day |
Related information
URL releasing protocol
http://www.jskd.jp/about/research.html
Publication of results
Partially published
Result
URL related to results and publications
http://www.jskd.jp/about/research.html
Number of participants that the trial has enrolled
310
Results
1. Two-thirds of dropout cases dropped out after high school graduation.
2. Significantly fewer patients in the dropout group had evidence of ischemia than those in the follow-up group.
3. The dropout cases had a tendency to having a history of hospital transfer.
4. Among patients who died, all patients had giant aneurysms in the LMT, and none had regression of aneurysms in the branch coronary arteries.
5. Among patients who died, more patients had a history of ischemia.
Results date posted
| 2019 | Year | 09 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Kawasaki disease patients with GAs identified from the 12th-14th nation-wide surveys (1991-1996) for KD patients in Japan
Participant flow
We sent questionnaires to medical institutions that participated in the 12th -14th nation-wide survey for KD patients in Japan.
We repeated the questionnaire investigation at the subsequent medical institutions to which patients were transferred.
Adverse events
none
Outcome measures
1. Patient information: patients' initials, date of birth, gender, date of onset of KD
2. Initial status of CAL (left main trunk (LMT), left anterior descending (LAD), left circumflex (LCX), right coronary artery (RCA))
3. Changes in CAL status during the follow-up period (LMT, LAD, LCX, RCA)
1) no change 2) regression 3) stenosis 4) obstruction
4. Presence or absence of ischemia, KD-related emergency hospitalization
5. Presence or absence of cardiac surgery
6. Presence or absence of catheter intervention
7. Presence or absence of oral medication (especially warfarin)
8. Final date of attending the hospital
9. Next scheduled date for consultation
10. Presence or absence of hospital transfer
11. Hospital information after transfer
12. Outcome of patient (survival or death)
13. In fatal cases, KD-related death or non-KD related death
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 01 | Month | 15 | Day |
Other
Other related information
Follow up status of adult Kawasaki disease patients with giant aneurysm reported in 12th -14th nation-wide survey (1991-1996) for KD patients in Japan will be investigated in questionary investigation and analyzed with several factors.
Management information
Registered date
| 2017 | Year | 08 | Month | 21 | Day |
Last modified on
| 2019 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032905
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
