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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Hospices Civils de Lyon.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01440075
First received: September 21, 2011
Last updated: September 22, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Kawasaki Disease
Other: Cardiac evaluation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Prevalence and Early Markers of Atherosclerosis in Adults With a History of Kawasaki Disease

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Early markers of atherosclerosis [ Time Frame: 1 day ] [ Designated as safety issue: No ]

    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.


Estimated Enrollment: 100
Study Start Date: June 2011
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Patients KD
Adults with a history of KD disease in childhood
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

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


  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440075

Contacts
Contact: Sylvie Di Filippo, Pr +33 472 357 389 sylvie.di-filippo@chu-lyon.fr

Locations
France
Hopital cardiologique Louis Pradel Recruiting
Bron, France, 69677
Contact: Sylvie Di Filippo, Pr    +33 472 357 389    sylvie.di-filippo@chu-lyon.fr   
Principal Investigator: Sylvie Di Filippo, Pr         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Sylvie Di Filippo, Pr Hospices Civiles de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01440075     History of Changes
Other Study ID Numbers: 2009.593
Study First Received: September 21, 2011
Last Updated: September 22, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Kawasaki disease

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Mucocutaneous Lymph Node Syndrome
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Vasculitis
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014