Prevalence and Early Markers of Atherosclerosis in Adults With a History of Kawasaki Disease

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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