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

NCT05434611 | Unknown

• 1 other identifier: PYan
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diagnoses Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• CRP

  From date of randomization until the date of first documented progression, whichever came first, assessed up to 18 months

Study Arms (2)

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

Healthy controls

Healthy control group were healthy children who underwent outpatient physical examination.

Diagnostic Test: S100A12

Interventions

S100A12 DIAGNOSTIC_TEST

The early dynamic detection of S100A12 was used to determine whether it was an auxiliary diagnostic index for Kawasaki disease

Healthy controls; Kawasaki disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital of Yangtze University: lead

Study Officials

• Qihong Fan, Dr.

  Yangtze University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Pan, Dr.

CONTACT

08618163139706; woshipanyan@126.com

Qihong Fan, Dr.

CONTACT

08618972161050; jzfqh163@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 28, 2022
• Study Start: July 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 30, 2023
• Last Updated: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share