Tokyo, July 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062380) titled 'A study on whether atopic dermatitis is associated with a higher risk of developing infective endocarditis, using a health insurance claims database' on July 29.

Study Type: Observational

Primary Sponsor: Institute - The University of Osaka, Graduate School of Medicine Faculty of Medicine

Condition: Condition - Infective endocarditis (outcome) and atopic dermatitis (exposure) Classification by malignancy - Others Genomic information - NO

Objective: 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

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 Size - 2000

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071392

Disclaimer: Curated by HT Syndication.