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Trial record 4 of 31 for:    "Kawasaki syndrome"

Measurement of Antibodies in Adults With a History of Kawasaki Disease (KAWASAKI Ac)

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ClinicalTrials.gov Identifier: NCT02853266
Recruitment Status : Unknown
Verified July 2016 by Hospices Civils de Lyon.
Recruitment status was:  Active, not recruiting
First Posted : August 2, 2016
Last Update Posted : August 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment
Kawasaki Disease Other: laboratory biomarker analysis

Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measurement of Antibodies in Adults With a History of Kawasaki Disease
Study Start Date : September 2011
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kawasaki Disease

Group/Cohort Intervention/treatment
patients KD
adults with a history of KD in childhood
Other: laboratory biomarker analysis
Archived serum samples are analysed for measurement of biomarker NCRA

control group
healthy adults volunteers
Other: laboratory biomarker analysis
Archived serum samples are analysed for measurement of biomarker NCRA




Primary Outcome Measures :
  1. Prevalence of NCRA in the KD population vs control population. [ Time Frame: at recruitment time. (Day 0) ]
  2. NCRA concentration in the KD population vs control population. [ Time Frame: at recruitment time. (Day 0) ]
    Measurement of the biomarker NCRA in serum in adults with a history of KD vs control population


Biospecimen Retention:   Samples Without DNA
de-identified and study coded serum sample


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients enrolled in Kawasaki study
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

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): NCT02853266


Locations
France
Hôpital Louis Pradel - Service de Pharmacologie Clinique
Bron, France, 69500
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: François Gueyffier, Pr Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02853266     History of Changes
Other Study ID Numbers: 69HCL16_0477
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: July 2016

Keywords provided by Hospices Civils de Lyon:
Kawasaki disease
non-cruzi-related antibody (NCRA)

Additional relevant MeSH terms:
Mucocutaneous Lymph Node Syndrome
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs