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

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 Overview

• Status: Unknown
• Conditions: Kawasaki Disease
• Intervention / Treatment: Other: laboratory biomarker analysis

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Hôpital Louis Pradel - Service de Pharmacologie Clinique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients enrolled in Kawasaki study

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of NCRA in the KD population vs control population.		at recruitment time. (Day 0)
NCRA concentration in the KD population vs control population.	Measurement of the biomarker NCRA in serum in adults with a history of KD vs control population	at recruitment time. (Day 0)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: François Gueyffier, Pr, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): December 1, 2015
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: July 21, 2016
• First Submitted That Met QC Criteria: July 28, 2016
• First Posted (Estimate): August 2, 2016

Study Record Updates

• Last Update Posted (Estimate): August 2, 2016
• Last Update Submitted That Met QC Criteria: July 28, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Kawasaki disease; non-cruzi-related antibody (NCRA)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Lymphatic Diseases; Vasculitis; Skin Diseases, Vascular; Mucocutaneous Lymph Node Syndrome
• Other Study ID Numbers: 69HCL16_0477