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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 prospectiv

Detailed Summary:
Sponsor: Hospices Civils de Lyon

Current 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Early markers of atherosclerosis [ Time Frame: 1 day ]

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.


Original Secondary Outcome: Same as current

Information By: Hospices Civils de Lyon

Dates:
Date Received: September 21, 2011
Date Started: September 2011
Date Completion: March 2016
Last Updated: September 15, 2015
Last Verified: September 2015