Genetic Determinants of Kawasaki Disease

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Brief Title

Genetic Determinants of Kawasaki Disease

Official Title

Genetic Determinants of Kawasaki Disease for Susceptibility and Outcome

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.
    

Detailed 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
    


Study Type

Observational


Primary Outcome

Susceptibility of coronary artery aneurysms for Kawasaki patients

Secondary Outcome

 Disease severity for Kawasaki patients

Condition

Kawasaki Disease


Study Arms / Comparison Groups

 Kawasaki disease
Description:  Kawasaki disease affected childrens

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

1299

Start Date

February 25, 2013

Completion Date

December 30, 2022

Primary Completion Date

December 30, 2022

Eligibility Criteria

        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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Professor M Levin, , [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT03861130

Organization ID

13SM0678


Responsible Party

Sponsor

Study Sponsor

Imperial College London

Collaborators

 Guy's and St Thomas' NHS Foundation Trust

Study Sponsor

Professor M Levin, Study Chair, Imperial College London


Verification Date

August 2019