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Genetic Determinants of Kawasaki Disease

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ClinicalTrials.gov Identifier: NCT03861130
Recruitment Status : Recruiting
First Posted : March 4, 2019
Last Update Posted : March 4, 2019
Sponsor:
Collaborators:
Guy's and St Thomas' NHS Foundation Trust
University Hospitals Bristol NHS Foundation Trust
Great Ormond Street Hospital for Children NHS Foundation Trust
UK Kawasaki Support Group
Imperial College Healthcare NHS Trust
Information provided by (Responsible Party):
Imperial College London

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.

Condition or disease
Kawasaki Disease Atypical Kawasaki Disease

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


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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Genetic Determinants of Kawasaki Disease for Susceptibility and Outcome
Actual Study Start Date : February 25, 2013
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kawasaki Disease




Primary Outcome Measures :
  1. Susceptibility of coronary artery aneurysms for Kawasaki patients [ Time Frame: end date; 30 December 2022 ]
    Identification of genes that are associated with susceptibility of coronary artery aneurysms


Secondary Outcome Measures :
  1. Disease severity for Kawasaki patients [ Time Frame: end date; 30 December 2022 ]
    Identification of genes that are associated with disease severity


Biospecimen Retention:   Samples With DNA
EDTA, Paxgene tube, plasma, serum, urine, throat swab, saliva


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children under the care of consultant in hospital for Kawasaki disease, families who are members of the UK Kawasaki Support Group
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03861130


Contacts
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Contact: Jethro Herberg j.herberg@imperial.ac.uk
Contact: Rachel Galassini r.galassini@imperial.ac.uk

Locations
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United Kingdom
Imperial College London Recruiting
London, United Kingdom, W2 1PG
Contact: Jethro Herberg       j.herberg@imperial.ac.uk   
Contact: Rachel Galassini       r.galassini@imperial.ac.uk   
Principal Investigator: Michael Levin         
Principal Investigator: Herberg Jethro         
Sponsors and Collaborators
Imperial College London
Guy's and St Thomas' NHS Foundation Trust
University Hospitals Bristol NHS Foundation Trust
Great Ormond Street Hospital for Children NHS Foundation Trust
UK Kawasaki Support Group
Imperial College Healthcare NHS Trust
Investigators
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Study Chair: Professor M Levin Imperial College London

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03861130     History of Changes
Other Study ID Numbers: REC ref 13/LO/0026
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Mucocutaneous Lymph Node Syndrome
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases