Measurement of Antibodies in Adults With a History of Kawasaki Disease

Kawasaki Disease Clinical Trial

— KAWASAKI Ac  

Official title:

Measurement of Antibodies in Adults With a History of Kawasaki Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02853266
• Other study ID #: 69HCL16_0477
• Status: Active, not recruiting
• Phase: N/A
• First received: July 21, 2016
• Last updated: July 28, 2016
• Start date: September 2011
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kawasaki Disease
• Mucocutaneous Lymph Node Syndrome

Intervention

Other:
• laboratory biomarker analysis
Archived serum samples are analysed for measurement of biomarker NCRA

Locations

Country	Name	City	State
France	Hôpital Louis Pradel - Service de Pharmacologie Clinique	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of NCRA in the KD population vs control population.		at recruitment time. (Day 0)	No
Primary	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)	No