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

NCT01440075 | Completed

• 1 other identifier: 2009.593
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Kawasaki Disease

Keywords

Kawasaki disease

Outcome Measures

Primary Outcomes (1)

• Prevalence of carotid and coronary atherosclerotic plaques at vascular Doppler ultrasound and coronary scan in the KD population versus control population

  1 day

Secondary Outcomes (1)

• Early markers of atherosclerosis

  1 day

Study Arms (2)

Patients KD

OTHER

Adults with a history of KD disease in childhood

Other: Cardiac evaluation

Case Control

OTHER

Control group, healthy volunteers matched for age and sex with the KD group

Other: Cardiac evaluation

Interventions

Cardiac evaluation OTHER

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

Case Control; Patients KD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of KD before the age of 18, with or without macroscopic coronary lesions in the childhood phase. (KD group only)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hopital cardiologique Louis Pradel

Bron, 69677, France

Location

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sylvie Di Filippo, Pr

  Hospices Civiles de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: September 26, 2011
• Study Start: October 10, 2011
• Primary Completion: April 13, 2015
• Study Completion: April 13, 2015
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

FR (1)