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

Sponsor
The First Affiliated Hospital of Yangtze University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05434611
Collaborator
(none)
100
18

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: S100A12

Detailed Description

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Role of Calcium Binding Protein S100A12 in Diagnosis and Prognosis of Kawasaki Disease
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. S100A12 [From date of randomization until the date of first documented progression, whichever came first, assessed up to 18 months]

    S100A12 was increased in children with Kawasaki disease and decreased after gamma globulin treatment

Secondary Outcome Measures

  1. CRP [From date of randomization until the date of first documented progression, whichever came first, assessed up to 18 months]

    Measure the CRP value

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

â–ªDiagnostic 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • The First Affiliated Hospital of Yangtze University

Investigators

  • Principal Investigator: Qihong Fan, Dr., Yangtze University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pan Yan, Attending physician, The First Affiliated Hospital of Yangtze University
ClinicalTrials.gov Identifier:
NCT05434611
Other Study ID Numbers:
  • PYan
First Posted:
Jun 28, 2022
Last Update Posted:
Jun 28, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 28, 2022