Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305611
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-16
Brief Title:
European and North Indian Cohort of KaWasaki dIsease
Sponsor:
Meyer Childrens Hospital IRCCS
Organization:
Meyer Childrens Hospital IRCCS
Study Overview
Official Title:
Comparison and Performance of Kobayashi and Kawanet IVIg Resistance Scores in a Multi-centric European and North Indian Cohort of KaWasaki dIsease the KIWI Study
Status:
RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
Kawasaki disease KD is currently the leading cause of acquired heart diseases in children in developed countries Cardiac involvement is the main determinant of the long-term prognosis of these patients as coronary aneurisms CAAs may lead to ischemic heart disease and even sudden death The current standard of care for KD has consistently reduced CAAs frequency from 25-30 to about 5 Unfortunately 10-20 of KD patients results resistant to standard treatment leading to a major risk of cardiac complications Thus scoring systems have been constructed in order to identify patients likely to be resistant to IVIG and who may benefit from more aggressive initial therapy Different scoring scales developed by Kobayashi Egami et Sano had shown a good sensitivity 77-86 and specificity 67-86 in predicting IVIG unresponsiveness in Japanese populations However their predictive value was not confirmed by subsequent studies in different ethnic populations Recently the French Kawanet group have proposed a IVIG unresponsiveness score that provided good sensitivity and acceptable specificity in a non-Asian KD population even if it was not subsequent validated by an external study In our study population the achievement of specificity and sensitivity values for both scores consistent with those reported by the original studies sensitivity 70 and specificity 80 for Kobayashi and sensitivity 77 and specificity 60 for Kawanet will be considered a success
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None