UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062380 |
|---|---|
| Receipt number | R000071392 |
| Scientific Title | Association between atopic dermatitis and the risk of incident infective endocarditis: a nested case-control study using the JMDC Claims Database |
| Date of disclosure of the study information | 2026/07/29 |
| Last modified on | 2026/07/29 11:13:23 |
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Basic information
Public title
A study on whether atopic dermatitis is associated with a higher risk of developing infective endocarditis, using a health insurance claims database
Acronym
AD-IE Association Study (JMDC)
Scientific Title
Association between atopic dermatitis and the risk of incident infective endocarditis: a nested case-control study using the JMDC Claims Database
Scientific Title:Acronym
AD-IE Nested Case-Control Study (JMDC)
Region
| Japan |
Condition
Condition
Infective endocarditis (outcome) and atopic dermatitis (exposure)
Classification by specialty
| Cardiology | Infectious disease | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Within a source cohort defined in the JMDC Claims Database (insurer and older-adults databases), to compare patients who developed infective endocarditis (cases) with controls at risk at the same time (4 controls per case, matched on age, sex and calendar year), and to evaluate whether atopic dermatitis before the index date is associated with incident infective endocarditis, using a nested case-control design and conditional logistic regression.
Basic objectives2
Others
Basic objectives -Others
Observational epidemiological study evaluating the association between a risk factor (atopic dermatitis) and an outcome (incident infective endocarditis).
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
First incident infective endocarditis meeting the case definition during source-cohort follow-up. The case definition requires a principal admission diagnosis matching the target ICD-10 codes and receipt (claims) disease codes, with a hospital stay of 14 days or longer, or death or transfer within 14 days. The association with atopic dermatitis before the index date is estimated by conditional logistic regression (odds ratio, 95% CI).
Key secondary outcomes
(1) Sensitivity analyses: exposure redefined as an L20 diagnosis plus prescription of related treatments such as topical anti-inflammatory drugs; and outcome definitions varying the hospital-stay threshold and the range of disease codes. (2) Stratified analyses by database type (insurer vs older-adults) and by age group (children, adults, older adults). (3) Analyses with additional adjustment for healthcare-utilization indicators (number of outpatient visits, prior hospitalization, emergency visits, total number of claims).
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Individuals in the insurer or older-adults database of the JMDC Claims Database. (2) All ages. (3) At least 12 months of continuous enrollment before the source-cohort entry date or each risk-set date. (4) Individuals in whom incident infective endocarditis can be ascertained during follow-up. Cases are those first meeting the infective endocarditis case definition during follow-up. For each case, 4 controls are selected from the risk set (enrolled and free of infective endocarditis at the case index date, with at least 12 months of look-back), matched on age, sex and calendar year (and database type as needed).
Key exclusion criteria
(1) A record of infective endocarditis within 12 months before the risk-set index date. (2) Less than 12 months of continuous enrollment before the index date. (3) Missing or inconsistent key information such as age, sex, or enrollment period. (4) Not meeting the matching conditions as a case or control.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kutsuna |
Organization
The University of Osaka, Graduate School of Medicine Faculty of Medicine
Division name
Department of Infection Prevention and Control
Zip code
565-0871
Address
2-2, Yamadaoka, Suita city
TEL
0836-6879-5111
kutsuna@hp-infect.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kutsuna |
Organization
The University of Osaka, Graduate School of Medicine Faculty of Medicine
Division name
Department of Infection Prevention and Control
Zip code
565-0871
Address
2-2, Yamadaoka, Suita city
TEL
0836-6879-5111
Homepage URL
kutsuna@hp-infect.med.osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka, Graduate School of Medicine Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
The University of Osaka
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
The University of Osaka Hospital, Ethical Review Board
Address
2-15, Yamadaoka, Suita city
Tel
0836-6879-5111
rinri@hp-crc.med.osaka-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
大阪大学大学院医学系研究科 感染制御学 / The University of Osaka, Graduate School of Medicine
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective nested case-control study using the JMDC Claims Database (insurer and older-adults databases). Using infective endocarditis cases within a source cohort and controls sampled from the risk set (4 per case), the association between prior atopic dermatitis and incident infective endocarditis is evaluated by conditional logistic regression.
Management information
Registered date
| 2026 | Year | 07 | Month | 29 | Day |
Last modified on
| 2026 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071392
