nctId: NCT06305611 id: KIWI briefTitle: European and North Indian Cohort of KaWasaki dIsease overallStatus: RECRUITING date: 2021-07-13 date: 2024-07-15 date: 2024-10-30 date: 2024-03-12 date: 2024-03-12 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: 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. conditions: Kawasaki Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 103 type: ESTIMATED measure: IVIG resistance rate measure: percentage of IVIG-resistant patients sex: ALL minimumAge: 1 Year maximumAge: 17 Years stdAges: CHILD facility: Universidade Federal do Rio de Janeiro status: RECRUITING city: Rio de Janeiro country: Brazil name: Adriana Fonseca role: CONTACT lat: -22.90278 lon: -43.2075 facility: Children's Hospital Zagreb status: RECRUITING city: Zagreb country: Croatia name: Alenka Gagro role: CONTACT lat: 45.81444 lon: 15.97798 facility: University Hospital Centre Zagreb, University School of Medicine status: RECRUITING city: Zagreb country: Croatia name: Marija Jelusic role: CONTACT lat: 45.81444 lon: 15.97798 facility: Le Kremlin-Bicetre University Hospital, Paris-Sud University - CEREMAI status: NOT_YET_RECRUITING city: Le Kremlin-Bicêtre country: France name: Isabelle Koné-Paut role: CONTACT lat: 48.81471 lon: 2.36073 facility: Manipal Hospital status: NOT_YET_RECRUITING city: Bangalore country: India name: Anand Prahalad Rao role: CONTACT lat: 12.97194 lon: 77.59369 facility: Postgraduate Institute of Medical Education and Research status: RECRUITING city: Chandigarh country: India name: Vignesh Pandiarajan role: CONTACT lat: 30.73629 lon: 76.7884 facility: Sri Ramachandra Medical Centre status: NOT_YET_RECRUITING city: Chennai country: India name: Mahesh Janarthanan role: CONTACT lat: 13.08784 lon: 80.27847 facility: Amrita Institute of Medical Sciences status: NOT_YET_RECRUITING city: Kochi country: India name: Suma Balan role: CONTACT lat: 9.93988 lon: 76.26022 facility: Institute of Child Health status: RECRUITING city: Kolkata country: India name: Priyankar Pal role: CONTACT lat: 22.56263 lon: 88.36304 facility: Vivekananda Institute of Medical Sciences status: NOT_YET_RECRUITING city: Kolkata country: India name: SUPARNA GUHA role: CONTACT lat: 22.56263 lon: 88.36304 facility: Meir Medical Centre status: NOT_YET_RECRUITING city: Kfar Saba country: Israel name: Ruby Haviv role: CONTACT lat: 32.175 lon: 34.90694 facility: ASST Papa Giovanni XXIII status: RECRUITING city: Bergamo country: Italy name: Lucio Verdoni role: CONTACT lat: 45.69601 lon: 9.66721 facility: Spedali Civili status: RECRUITING city: Brescia country: Italy name: Marco Cattalini role: CONTACT lat: 45.53558 lon: 10.21472 facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Florence country: Italy name: Gabriele Simonini role: CONTACT email: gabriele.simonini@meyer.it lat: 43.77925 lon: 11.24626 facility: IRCCS Istituto Giannina Gaslini status: RECRUITING city: Genova country: Italy name: Silvia Rosina role: CONTACT lat: 44.40478 lon: 8.94438 facility: Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico status: NOT_YET_RECRUITING city: Milano country: Italy name: Giovanni Filocamo role: CONTACT lat: 45.46427 lon: 9.18951 facility: P.O. "Giovanni Di Cristina" status: NOT_YET_RECRUITING city: Palermo country: Italy name: Maria Cristina Maggio role: CONTACT lat: 38.13205 lon: 13.33561 facility: Università di Torino status: RECRUITING city: Torino country: Italy name: Francesco Licciardi role: CONTACT lat: 45.07049 lon: 7.68682 facility: IRCCS Burlo Garofolo status: RECRUITING city: Trieste country: Italy name: andrea Taddio role: CONTACT lat: 45.64953 lon: 13.77679 facility: Beatrix Kinderkliniek, University Medical Center status: NOT_YET_RECRUITING city: Groningen country: Netherlands name: Wineke Armbrust role: CONTACT lat: 53.21917 lon: 6.56667 facility: Hospital de Sabadell status: RECRUITING city: Barcellona country: Spain name: Judith Sanchez Manubens role: CONTACT lat: 41.38879 lon: 2.15899 facility: Hospital Sant Joan de Déu status: RECRUITING city: Barcellona country: Spain name: Jordi Anton role: CONTACT lat: 41.38879 lon: 2.15899 facility: Chiang Mai University Hospital status: RECRUITING city: Chiang Mai country: Thailand name: Watchareewan Sontichai role: CONTACT lat: 18.79038 lon: 98.98468 facility: Hacettepe University Children's Hospital status: RECRUITING city: Ankara country: Turkey name: Seza Ozen role: CONTACT lat: 39.91987 lon: 32.85427 facility: Health Sciences University, Umraniye Education and Research Hospital status: RECRUITING city: Istanbul country: Turkey name: Betul Sozeri role: CONTACT lat: 41.01384 lon: 28.94966 facility: Istanbul Uni. Istanbul Med.Fac status: NOT_YET_RECRUITING city: Istanbul country: Turkey name: Nuray Aktay Ayaz role: CONTACT lat: 41.01384 lon: 28.94966 facility: Royal Hospital for Children status: RECRUITING city: Bristol country: United Kingdom name: Athimalaipet Ramanan role: CONTACT lat: 51.45523 lon: -2.59665 hasResults: False