Genetic Determinants of Kawasaki Disease

Kawasaki Disease Clinical Trial

Official title:

Genetic Determinants of Kawasaki Disease for Susceptibility and Outcome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03861130
• Other study ID #: 13SM0678
• Status: Active, not recruiting
• Start date: February 25, 2013
• Est. completion date: December 30, 2022

Study information

• Verified date: November 2022
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The problem to be addressed;

Kawasaki disease is now the most common cause of acquired heart disease in children in Japan and North America. Kawasaki disease arises when genetically predisposed children encounter an as yet unidentified infectious agent which may cause only mild illness or no illness at all in children without the genetic predisposition. Other children may suffer permanent damage to the coronary arteries. Identification of the genes involved will help to improve understanding of the disease, and the development of better treatments.

Objective

The investigators aim to identify the genes underlying both susceptibility to Kawasaki disease, and the development of coronary artery aneurysms.

Design

The study will recruit nuclear families (affected child and their biological parents) through participating NHS hospitals or through the records of the UK Kawasaki Support Group.

Study size

400 affected children and both biological parents (i.e. 1200 participants)

Procedures

Informed consent using age appropriate patient/parent/guardian information sheets will be taken from parents (or from children aged 16 and over), assent will be taken from the child under the age of 16 (if appropriate). Children recruited during the acute illness; routine clinical and laboratory data and research samples (blood, urine, throat swab). Children recruited retrospectively; study questionnaire (completed by parents), saliva samples.Saliva samples from parents

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1379
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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:

1. Changes in the peripheral extremities Acute: erythema and oedema of hands and feet Convalescent: membranous desquamation of fingertips

2. Polymorphous exanthema

3. Bilateral painless bulbar conjunctival injection without exudate

4. Changes in lips and oral cavity: erythema and cracking of lips, strawberry tongue, diffuse injection of oral and pharyngeal mucosae

5. 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Atypical Kawasaki Disease
• Kawasaki Disease
• Mucocutaneous Lymph Node Syndrome

Locations

Country	Name	City	State
United Kingdom	Imperial College London	London

Sponsors (45)

Lead Sponsor

Collaborator

Imperial College London

Airedale General Hospital, Birmingham Children's Hospital, Bradford Royal Infirmary, Burton Hospitals NHS Foundation Trust, Calderdale and Huddersfield NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, Darlington Memorial Hospital, East Suffolk and North Essex NHS Foundation Trust, East Surrey Hospital, Great Ormond Street Hospital for Children NHS Foundation Trust, Guy's and St Thomas' NHS Foundation Trust, Imperial College Healthcare NHS Trust, Kingston Hospital NHS Trust, Leeds General Infirmary, Macclesfield District General Hospital, New Cross Hospital, North Manchester General Hospital, Northwick Park Hospital, Peterborough City Hospital, Pinderfields General Hospital, Royal Albert Edward Infirmary, Royal Alexandra Children's Hospital, Royal Bolton Hospital NHS Foundation Trust, Royal Cornwall Hospitals Trust, Royal Oldham Hospital, Sheffield Children's NHS Foundation Trust, South Tees Hospitals NHS Foundation Trust, St. George's Hospital, London, St. Richard's Hospital, Stepping Hill Hospital, Tameside Hospital NHS Foundation Trust, The Shrewsbury and Telford Hospital NHS Trust, Torbay Hospital, UK Kawasaki Support Group, University Hospital Birmingham NHS Foundation Trust, University Hospital of North Tees, University Hospitals Bristol and Weston NHS Foundation Trust, University Hospitals Coventry and Warwickshire NHS Trust, University Hospitals of Morecambe Bay NHS Trust, University Hospitals of North Midlands NHS Trust, West Middlesex Hospital, Worthing Hospital, Wye Valley NHS Trust, York Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Disease severity for Kawasaki patients	Identification of genes that are associated with disease severity	end date; 30 December 2022