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

Kawasaki Disease Clinical Trial

— Kawasaki  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440075
• Other study ID #: 2009.593
• Status: Completed
• Phase: N/A
• First received: September 21, 2011
• Last updated: August 18, 2017
• Start date: October 10, 2011
• Est. completion date: April 13, 2015

Study information

• Verified date: August 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 13, 2015
• Est. primary completion date: April 13, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Kawasaki Disease
• Mucocutaneous Lymph Node Syndrome

Intervention

Other:
• Cardiac evaluation
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

Locations

Country	Name	City	State
France	Hopital cardiologique Louis Pradel	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of carotid and coronary atherosclerotic plaques at vascular Doppler ultrasound and coronary scan in the KD population versus control population		1 day
Secondary	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.	1 day