NCT03861130

Brief Summary

Kawasaki disease (KD) is an acute self-limited vasculitis of infancy and early childhood. Most patients recover without sequelae although the inflammatory process causes permanent damage to the coronary arteries in 20-25% of untreated children. An infectious aetiology is suspected, but the causative agent has not been identified. The investigators aim to identify the genes underlying both susceptibility to Kawasaki disease, and the development of coronary artery aneurysms.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,379

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2013

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

November 17, 2022

Status Verified

November 1, 2022

Enrollment Period

9.8 years

First QC Date

March 1, 2019

Last Update Submit

November 15, 2022

Conditions

Kawasaki DiseaseAtypical Kawasaki Disease

Keywords

Kawasaki Disease

Outcome Measures

Primary Outcomes (1)

  • Susceptibility of coronary artery aneurysms for Kawasaki patients

    Identification of genes that are associated with susceptibility of coronary artery aneurysms

    end date; 30 December 2022

Secondary Outcomes (1)

  • Disease severity for Kawasaki patients

    end date; 30 December 2022

Study Arms (2)

Kawasaki disease

Kawasaki disease affected children

parent of Kawasaki disease affected child

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Children under the care of consultant in hospital for Kawasaki disease, families who are members of the UK Kawasaki Support Group

You may qualify if:

  • Affected children will be recruited if the treating clinician has made a diagnosis of possible Kawasaki disease (even if they do not fulfil the criteria below for Kawasaki disease).
  • The current standard diagnostic criteria for KD (Circulation 2001 103 335-336 doi: 10.1161/01.CIR 103.2.335) are:
  • The presence of fever for at least five days plus four of the following criteria:
  • Changes in the peripheral extremities Acute: erythema and oedema of hands and feet Convalescent: membranous desquamation of fingertips
  • Polymorphous exanthema
  • Bilateral painless bulbar conjunctival injection without exudate
  • Changes in lips and oral cavity: erythema and cracking of lips, strawberry tongue, diffuse injection of oral and pharyngeal mucosae
  • Cervical lymphadenopathy (\>1.5cm diameter), usually unilateral Patients meeting not all of these criteria may meet the criteria for atypical Kawasaki disease, ie. if they have fever and two or three of the above criteria and elevation of CRP or echocardiographic evidence of coronary artery dilatation.
  • Parents of affected child must be biological parents.

You may not qualify if:

  • children who do not have a diagnosis of possible Kawasaki disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College London

London, W2 1PG, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

EDTA, Paxgene tube, plasma, serum, urine, throat swab, saliva

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome

Condition Hierarchy (Ancestors)

VasculitisVascular DiseasesCardiovascular DiseasesLymphatic DiseasesHemic and Lymphatic DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Professor M Levin

    Imperial College London

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2019

First Posted

March 4, 2019

Study Start

February 25, 2013

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

November 17, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)