Ignite Creation Date:
2024-05-05 @ 11:54 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01440075
Status:
COMPLETED
Last Update Posted:
2017-08-22
First Post:
2011-09-21
Brief Title:
Prevalence and Early Markers of Atherosclerosis in Adults With a History of Kawasaki Disease
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Prevalence and Early Markers of Atherosclerosis in Adults With a History of Kawasaki Disease
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Kawasaki
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 US 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 patients 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
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 US 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 patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None