Brief Title
Prevalence and Early Markers of Atherosclerosis in Adults With a History of Kawasaki Disease
Official Title
Prevalence and Early Markers of Atherosclerosis in Adults With a History of Kawasaki Disease
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. 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 Type
Interventional
Primary Outcome
Prevalence of carotid and coronary atherosclerotic plaques at vascular Doppler ultrasound and coronary scan in the KD population versus control population
Secondary Outcome
Early markers of atherosclerosis
Condition
Kawasaki Disease
Intervention
Cardiac evaluation
Study Arms / Comparison Groups
Patients KD
Description: Adults with a history of KD disease in childhood
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
43
Start Date
October 10, 2011
Completion Date
April 13, 2015
Primary Completion Date
April 13, 2015
Eligibility Criteria
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
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Sylvie Di Filippo, Pr, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT01440075
Organization ID
2009.593
Responsible Party
Sponsor
Study Sponsor
Hospices Civils de Lyon
Study Sponsor
Sylvie Di Filippo, Pr, Principal Investigator, Hospices Civiles de Lyon
Verification Date
August 2017