Prevalence and Early Markers of Atherosclerosis in Adults With a History of Kawasaki Disease (Kawasaki)
Primary Purpose
Kawasaki Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cardiac evaluation
Sponsored by
About this trial
This is an interventional health services research trial for Kawasaki Disease focused on measuring Kawasaki disease
Eligibility 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
Sites / Locations
- Hopital cardiologique Louis Pradel
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patients KD
Case Control
Arm Description
Adults with a history of KD disease in childhood
Control group, healthy volunteers matched for age and sex with the KD group
Outcomes
Primary Outcome Measures
Prevalence of carotid and coronary atherosclerotic plaques at vascular Doppler ultrasound and coronary scan in the KD population versus control population
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01440075
First Posted
September 21, 2011
Last Updated
August 18, 2017
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT01440075
Brief Title
Prevalence and Early Markers of Atherosclerosis in Adults With a History of Kawasaki Disease
Acronym
Kawasaki
Official Title
Prevalence and Early Markers of Atherosclerosis in Adults With a History of Kawasaki Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 10, 2011 (Actual)
Primary Completion Date
April 13, 2015 (Actual)
Study Completion Date
April 13, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kawasaki Disease
Keywords
Kawasaki disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients KD
Arm Type
Other
Arm Description
Adults with a history of KD disease in childhood
Arm Title
Case Control
Arm Type
Other
Arm Description
Control group, healthy volunteers matched for age and sex with the KD group
Intervention Type
Other
Intervention Name(s)
Cardiac evaluation
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Early markers of atherosclerosis
Description
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.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvie Di Filippo, Pr
Organizational Affiliation
Hospices Civiles de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital cardiologique Louis Pradel
City
Bron
ZIP/Postal Code
69677
Country
France
12. IPD Sharing Statement
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Prevalence and Early Markers of Atherosclerosis in Adults With a History of Kawasaki Disease
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