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