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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01440075
First Posted: September 26, 2011
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospices Civils de Lyon
  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: None (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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 43
Actual Study Start Date: October 10, 2011
Study Completion Date: April 13, 2015
Primary Completion Date: April 13, 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01440075


Locations
France
Hopital cardiologique Louis Pradel
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Sylvie Di Filippo, Pr Hospices Civiles de Lyon
  More Information

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01440075     History of Changes
Other Study ID Numbers: 2009.593
First Submitted: September 21, 2011
First Posted: September 26, 2011
Last Update Posted: August 22, 2017
Last Verified: August 2017

Keywords provided by Hospices Civils de Lyon:
Kawasaki disease

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