Kawasaki DiseaseKAWASAKI AcNCT02853266
Measurement of Antibodies in Adults With a History of Kawasaki Disease
An observational study of Kawasaki Disease, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Kawasaki Disease
- What is being tested?
- laboratory biomarker analysis
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2011to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients enrolled in Kawasaki study
Who may be able to join
- 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
Who cannot join
- - 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,
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Louis Pradel - Service de Pharmacologie Clinique
Bron, 69500
About this study
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.
Read more
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.
- Conditions
- Kawasaki Disease
- Being tested
- laboratory biomarker analysis
- Keywords
- Kawasaki disease, non-cruzi-related antibody (NCRA)
- Medical subject headings
- Mucocutaneous Lymph Node Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
Archived serum samples are analysed for measurement of biomarker NCRA
| Study group | Role | What they receive |
|---|---|---|
| patients KD | adults with a history of KD in childhood Receives: Other: laboratory biomarker analysis | |
| control group | healthy adults volunteers Receives: Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of NCRA in the KD population vs control population.
Measured: 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
Measured: at recruitment time. (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startSep 2011
- Primary completionDec 2015
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kawasaki DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Gueyffier, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853266
- Sponsor's protocol ID
- 69HCL16_0477
- Acronym
- KAWASAKI Ac
- Status last verified
- Jul 2016
- First submitted
- 21 Jul 2016
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Antibodies in Adults With a History of Kawasaki Disease
- ClinicalTrials.gov ID
- NCT02853266
- Acronym / sponsor ID
- KAWASAKI Ac / 69HCL16_0477
- Conditions
- Kawasaki Disease
- Keywords
- Kawasaki disease, non-cruzi-related antibody (NCRA)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 2 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients KD | – | Other: laboratory biomarker analysisadults with a history of KD in childhood |
| control group | – | Other: laboratory biomarker analysishealthy adults volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients enrolled in Kawasaki study
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- - 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laboratory biomarker analysisArchived serum samples are analysed for measurement of biomarker NCRA | Other | control group, patients KD |
Primary outcome
Prevalence of NCRA in the KD population vs control population.
Time frame: at recruitment time. (Day 0)
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Gueyffier, Pr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kawasaki Disease, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of NCRA in the KD population vs control population. (time frame: at recruitment time. (Day 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2016.