Role of Calcium Binding Protein S100A12 in Diagnosis and Prognosis of Kawasaki Disease

Recent studies showed that the value of c100A12 increased in children with Kawasaki disease, and decreased rapidly after treatment with gamma globulin. In kawasaki disease with coronary artery dilatation, S100A12 levels are elevated in the acute phase of Kawasaki disease and continue for some time in the convalescence phase before gradually decreasing. However, the number of patients included in previous studies was small and the follow-up time was short. In this study, 100 children with Kawasaki disease who were admitted to Wuhan Children's Hospital, Jingzhou First People's Hospital and Renhe Hospital affiliated to China Three Gorges University from December 2021 to December 2023 were selected as the research objects, and 100 children with healthy physical examination were selected as the control group during the same period. To investigate whether S100A12 increased significantly in the acute phase of Kawasaki disease compared with a healthy control group. To study whether S100A12 value increased rather than decreased in kawasaki disease that did not respond to gamma globulin treatment after gamma globulin treatment. At the same time, to study whether the increase of S100A12 in kawasaki disease convalescence indicates coronary aneurysm.

Study Overview

• Status: Not yet recruiting
• Conditions: Diagnoses Disease
• Intervention / Treatment: Diagnostic test: S100A12

Detailed Description

S100A12 was determined using the ELISA kit and according to the instructions.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Yan Pan, Dr.; Phone Number: 08618163139706; Email: woshipanyan@126.com
• Study Contact Backup: Name: Qihong Fan, Dr.; Phone Number: 08618972161050; Email: jzfqh163@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The case group consisted of 50 hospitalized children with Kawasaki disease. The healthy control group consisted of 50 healthy children.

Description

Inclusion Criteria:

▪Diagnostic criteria of Kawasaki disease revised by the American Heart Association in 2017

Exclusion Criteria:

• Scarlet fever
• Drug allergy syndrome
• Stevens-Johnson syndrome
• Toxic shock syndrome
• Adenovirus infection
• Epstein-Barr(EB) virus infection

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Kawasaki disease; All children with Kawasaki disease met the diagnostic criteria for Kawasaki disease revised by the American Heart Association in 2017.	Diagnostic test: S100A12; The early dynamic detection of S100A12 was used to determine whether it was an auxiliary diagnostic index for Kawasaki disease
Healthy controls; Healthy control group were healthy children who underwent outpatient physical examination.	Diagnostic test: S100A12; The early dynamic detection of S100A12 was used to determine whether it was an auxiliary diagnostic index for Kawasaki disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
S100A12	S100A12 was increased in children with Kawasaki disease and decreased after gamma globulin treatment	From date of randomization until the date of first documented progression, whichever came first, assessed up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRP	Measure the CRP value	From date of randomization until the date of first documented progression, whichever came first, assessed up to 18 months

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Yangtze University
• Investigators: Principal Investigator: Qihong Fan, Dr., Yangtze University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: June 21, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 21, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Lymphatic Diseases; Vasculitis; Skin Diseases, Vascular; Disease; Mucocutaneous Lymph Node Syndrome
• Other Study ID Numbers: PYan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No