Ignite Creation Date:
2024-05-06 @ 8:54 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02853266
Status:
UNKNOWN
Last Update Posted:
2016-08-02
First Post:
2016-07-21
Brief Title:
Measurement of Antibodies in Adults With a History of Kawasaki Disease
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Measurement of Antibodies in Adults With a History of Kawasaki Disease
Status:
UNKNOWN
Status Verified Date:
2016-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KAWASAKI Ac
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 heartThe 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
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 heartThe 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None