Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-25 @ 4:36 AM
NCT ID:
NCT04535518
Eligibility Criteria:
Inclusion Criteria:
* Meeting diagnostic criteria for KD released by American Heart Association (AHA) in 2017, including complete KD (also sometimes referred to as typical or classic KD) and incomplete KD ((also sometimes referred to as atypical KD);
* Diagnosed within 14 days of illness (including the 14th day, considering the first day of illness as the first day of fever);
* Not treated with IVIG or other treatments for KD yet;
* Z score of any coronary artery of LMCA, LAD, LCX, the proximal and middle segment of RCA ≥ 2 calculated based on the height, weight and coronary artery diameter measured by echocardiography;
* Aged between one month and 14 years.
Exclusion Criteria:
* Receiving steroids or other immunosuppressive agents in the previous 30 days;
* With a previous history of KD;
* Afebrile and all the inflammation indicators (including white blood cell count, CRP, and erythrocyte sedimentation) become normal before enrolment;
* With suspected infectious diseases including tuberculosis, sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella, influenza, EBV infection, etc;
* With serious immune diseases such as immunodeficiency or chromosomal abnormalities;
* Unable to be followed up for at least 1 year.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
14 Years
Study:
NCT04535518
Study Brief:
Protocol Section:
NCT04535518