Kawasaki DiseaseKawasakiNCT01440075
Prevalence and Early Markers of Atherosclerosis in Adults With a History of Kawasaki Disease
A study testing Cardiac evaluation in people with 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. The annual incidence in children under 5 years in Europe is estimated at 8 to 100000. 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?
- Cardiac evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2011to 13 Apr 2015
- Phase
- Interventional
- 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
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.
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. The annual incidence in children under 5 years in Europe is estimated at 8 to 100000. 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.
Read more
It may results in acquired heart disease in children in developed countries, and may be the cause of premature coronary artery disease in adulthood.
A polymorphism was recently associated with the occurrence of disease in a Japanese and U.S population. (C allele of SNP itpkc_3, with a risk multiplied by 2). However, data are conflicting on this issue and the prevalence of this allel is unknown in North America and Europe populations.
The clinical picture of KD associate a persistent fever and an antipyretics resistance with mucocutaneous signs and bulky cervical lymphadenopathy usually unilateral. Diagnosis is confirmed by the presence of five clinical signs (major criteria). The presence of inconsistent coronary lesions in cardiac ultrasound can confirm the diagnosis.
KD can resolve spontaneously with no treatment. The severity of the disease is primarily related to complications of coronary aneurysms in acute or chronic stages.
Several arguments support the fact that adult patients have diffuse vascular lesions different from aneurysmal lesions initially described in childhood.
Despite abundance of publications on KD, there is no prospective or retrospective study which explored anomalies resulting from KD in adult subjects.
Therefore, this project will describe the patient's vascular evolution, the prevalence of atherosclerotic lesions and to determine the biological and functional abnormalities, markers of accelerated atherosclerosis.
Hypothesis : A history of Kawasaki disease represents a cardiovascular risk factor in adulthood.
The main objective is to evaluate the prevalence of atherosclerotic lesions, their extent and their severity in adults with a history of KD in childhood compared to a control population.
- Conditions
- Kawasaki Disease
- Being tested
- Cardiac evaluation
- Keywords
- Kawasaki disease
- 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.
Cardiac evaluationOther
complete cardiac evaluation with :
Electrocardiogram Echodoppler Echodoppler with dobutamine stress Carotid Echodoppler Coronary scan Positron emission tomography with adenosine stress Blood test (search for early atherosclerosis marker Genotyping
| Study group | Role | What they receive |
|---|---|---|
| Patients KD | Other | Adults with a history of KD disease in childhood Receives: Other: Cardiac evaluation |
| Case Control | Other | Control group, healthy volunteers matched for age and sex with the KD group Receives: Other: Cardiac evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of carotid and coronary atherosclerotic plaques at vascular Doppler ultrasound and coronary scan in the KD population versus control population
Measured: 1 day
Secondary outcomes (1)
Early markers of atherosclerosis
Secondary Outcomes consist of early markers of atherosclerosis:
- Carotid intima-media thickness
- Endothelial dysfunction of coronary arteries,
- Myocardial blood flow at rest and under pharmacological stress (adenosine)
- Myocardial systolic function overall and segmental at rest and under pharmacological stress (dobutamine)
- Early biological markers of atherosclerosis.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2011 (estimated)
- Study start10 Oct 2011
- Primary completion13 Apr 2015
- Study completion13 Apr 2015
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvie Di Filippo, Pr, Principal investigator, Hospices Civiles de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440075
- Sponsor's protocol ID
- 2009.593
- Acronym
- Kawasaki
- Status last verified
- Aug 2017
- First submitted
- 21 Sep 2011
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Early Markers of Atherosclerosis in Adults With a History of Kawasaki Disease
- ClinicalTrials.gov ID
- NCT01440075
- Acronym / sponsor ID
- Kawasaki / 2009.593
- Conditions
- Kawasaki Disease
- Keywords
- Kawasaki disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 10 Oct 2011 (actual)
- Primary completion
- 13 Apr 2015 (actual)
- Study completion
- 13 Apr 2015 (actual)
- First posted
- 26 Sep 2011 (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. The annual incidence in children under 5 years in Europe is estimated at 8 to 100000. 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.
It may results in acquired heart disease in children in developed countries, and may be the cause of premature coronary artery disease in adulthood.
A polymorphism was recently associated with the occurrence of disease in a Japanese and U.S population. (C allele of SNP itpkc_3, with a risk multiplied by 2). However, data are conflicting on this issue and the prevalence of this allel is unknown in North America and Europe populations.
The clinical picture of KD associate a persistent fever and an antipyretics resistance with mucocutaneous signs and bulky cervical lymphadenopathy usually unilateral. Diagnosis is confirmed by the presence of five clinical signs (major criteria). The presence of inconsistent coronary lesions in cardiac ultrasound can confirm the diagnosis.
KD can resolve spontaneously with no treatment. The severity of the disease is primarily related to complications of coronary aneurysms in acute or chronic stages.
Several arguments support the fact that adult patients have diffuse vascular lesions different from aneurysmal lesions initially described in childhood.
Despite abundance of publications on KD, there is no prospective or retrospective study which explored anomalies resulting from KD in adult subjects.
Therefore, this project will describe the patient's vascular evolution, the prevalence of atherosclerotic lesions and to determine the biological and functional abnormalities, markers of accelerated atherosclerosis.
Hypothesis : A history of Kawasaki disease represents a cardiovascular risk factor in adulthood.
The main objective is to evaluate the prevalence of atherosclerotic lesions, their extent and their severity in adults with a history of KD in childhood compared to a control population.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients KD | Other | Other: Cardiac evaluationAdults with a history of KD disease in childhood |
| Case Control | Other | Other: Cardiac evaluationControl group, healthy volunteers matched for age and sex with the KD group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Cardiac evaluationcomplete cardiac evaluation with : Electrocardiogram Echodoppler Echodoppler with dobutamine stress Carotid Echodoppler Coronary scan Positron emission tomography with adenosine stress Blood test (search for early atherosclerosis marker Genotyping | Other | Case Control, Patients KD |
Primary outcome
Prevalence of carotid and coronary atherosclerotic plaques at vascular Doppler ultrasound and coronary scan in the KD population versus control population
Time frame: 1 day
1 secondary outcome
Early markers of atherosclerosis
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
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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.
Sylvie Di Filippo, Pr principal investigator
Hospices Civiles de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac evaluation in people with 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: finished, as of the sponsor's last update on 22 Aug 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 carotid and coronary atherosclerotic plaques at vascular Doppler ultrasound and coronary scan in the KD population versus control population (time frame: 1 day). 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 22 Aug 2017.