Measurement of Antibodies in Adults With a History of Kawasaki Disease

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Brief Title

Measurement of Antibodies in Adults With a History of Kawasaki Disease

Official Title

Measurement of Antibodies in Adults With a History of Kawasaki Disease

Brief Summary

      Kawasaki disease (KD) is an acute systemic vasculitic syndrome with coronary tropism. It has
      been reported worldwide, but it is ten times more common in Asian population. It is the
      second vasculitis of the child by its frequency after rheumatoid purpura. It occurs in 80% of
      cases between 1 and 5 years, with a maximal incidence around the age of 12 months.

      KD is not well understood and the cause is yet unknown. It may be an autoimmune disorder. The
      problem affects the mucous membranes, lymph nodes, walls of the blood vessels, and the
      heart.The clinical picture of KD associate a persistent fever and an antipyretics resistance
      with mucocutaneous signs and bulky cervical lymphadenopathy usually unilateral.

      There is currently no vaccine available against Kawasaki disease so it is extremely important
      to be able to recognize symptoms before they set in and become too severe.

      Chagas disease (CD) is caused by the parasite Trypanosoma cruzi. Acute CD occurs immediately
      after infection, may last up to a few weeks or months. Infection may be mild or asymptomatic.
      There may be fever or swelling around the site of inoculation, and acute infection may result
      in severe inflammation of the heart muscle. The notion that the pathology of CD has an
      autoimmune component was initially based on the finding of circulating antibodies binding
      heart tissue antigens in patients chronically infected with T. cruzi.

      A recent study reports a possible antigen (non-cruzi-related antibody NCRA) mimicry
      characterized by a serological reactivity to a well-defined T. cruzi antigen in blood samples
      from individuals not exposed to the parasite. The measured seroprevalence of such
      cross-reactivity is in favor of a highly prevalent immunogen acquired in childhood.

      There are similarities in mechanism of CD and KD: it could be interesting to explore the
      presence of NCRA in blood samples from adults with a history of KD.

      The objective of the study is the measurement of the biomarker NCRA in serum in adults with a
      history of KD compare to a control population. This measurement and the prevalence may permit
      to associate the NCRA to a possible pathogenic agent.
    



Study Type

Observational


Primary Outcome

Prevalence of NCRA in the KD population vs control population.


Condition

Kawasaki Disease

Intervention

laboratory biomarker analysis

Study Arms / Comparison Groups

 patients KD
Description:  adults with a history of KD in childhood

Publications

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

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

75

Start Date

September 2011

Completion Date

December 2016

Primary Completion Date

December 2015

Eligibility Criteria

        Inclusion Criteria:

          -  History of KD before the age of 18, with or without macroscopic coronary lesions in
             the childhood phase. (KD group only)

          -  18 years old or older at the time of the study.

          -  Agree on participating to all explorations of the study.

          -  Accept genotyping.

          -  Absence of cardiovascular risk factors

        Exclusion Criteria:

          -  - Atypical KD (KD group only)

          -  Documented or suspected coronary ischemia,

          -  Refusal to participate to the study or sign the consent

          -  Contra-indication to the injection of iodinated contrast agents (allergy, renal
             failure)

          -  Hypersensitivity to dobutamine,

          -  No effective contraception method for females with child bearing potential,

          -  Breastfeeding, or pregnant females,

          -  Treatment modifying endothelial reactivity

          -  History of severe intolerance to iodinated contrast agents,

          -  Subjects who can't hold their breath for at least 20 seconds,

          -  Irregular or absence of sinus rhythm, especially atrial or ventricular arrhythmia

          -  Unability to give information to the subject,

          -  No coverage from a Social Security system

          -  Deprivation of civil rights
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

François Gueyffier, Pr, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02853266

Organization ID

69HCL16_0477


Responsible Party

Sponsor

Study Sponsor

Hospices Civils de Lyon


Study Sponsor

François Gueyffier, Pr, Principal Investigator, Hospices Civils de Lyon


Verification Date

July 2016