[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561522":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":27,"centralContacts":32,"locations":42,"responsibleParty":60,"collaborators":10,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":79,"studyType":80,"phases":10,"briefSummary":81,"conditions":82,"keywords":92,"overallStatus":45,"whyStopped":10,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Scientific Institute San Raffaele","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Arrhythmic (A)",null,"Arrhythmic Group. To oversimplify, specific subgroups of patients will be considered.\n\nGroup 1: major ventricular arrhythmias (haemodynamically unstable VT, hu-VT; ventricular fibrillation, VF).\n\nGroup 2: other ventricular arrhythmias (high-burden premature ventricular complexes = hb-PVC; nonsustained VT = NSVT; haemodynamically stable VT = hs-VT).\n\nGroup 3: bradyarrhythmias (2nd type II or 3rd degree atrioventricular block = advanced AVB; critical sinus pauses = SND).\n\nGroup 4: supraventricular arrhythmias (atrial fibrillation = AF; atrial flutter = AFlu; atrial tachycardia = AT).",[13],"Other: support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation",{"label":15,"type":10,"description":16,"interventionNames":17},"Nonarrhythmic (NA)","Nonarrhythmic Group. To oversimplify, specific subgroups of patients will be considered.\n\n1. Heart failure presentation (and subtypes)\n2. Chest pain presentation (and subtypes)\n3. Asymptomatic presentation\u002Fscreening (and subtypes)",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Subgroups","For specific study aims, different patient subgroups will be compared. The main groups are hereby reported:\n\nA. Arrhythmic myocarditis subgroups (1-4). B. Non-arrhythmic myocarditis subgroups (i.e.: fulminant, acute coronary syndrome-like, pericarditis-like, heart failure, nonischaemic dilated \u002Fhypokinetic cardiomyopathies of unknown aetiology…).\n\nC. Infectious vs. autoimmune vs. toxic myocarditis. D. Myocarditis treated by aetiology-based treatment vs. isolated cardiac medical treatment.\n\nE. Myocarditis at different disease stages: acute, hyperacute, fulminant, chronic active, post-inflammatory, or active vs. previous vs. non-myocarditis.\n\nF. Myocarditis presenting as organ-specific diseases vs. in the context of a genetic disorder or systemic disease.\n\nG. Myocarditis vs. peri-myocarditis\u002Fmyo-pericarditis. H. Other subgroups",[13],[23],{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation","Treatment will be patient-tailored, integrating international guidelines recommendation and the experience of the center where enrollment takes place.",[9,15,19],[28],{"name":29,"affiliation":30,"role":31},"Paolo Della Bella, MD","San Raffaele Scientific Institute, Milan, Italy","STUDY_CHAIR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":10,"email":37},"Giovanni Peretto, MD","CONTACT","+39 0226437482","peretto.giovanni@hsr.it",{"name":39,"role":35,"phone":40,"phoneExt":10,"email":41},"Simone Sala, MD","+39 0226437483","sala.simone@hsr.it",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"IRCCS San Raffaele Scientific Institute","RECRUITING","Milan","Milano","20132","Italy","IT",{"type":52,"coordinates":53},"Point",[54,55],9.18951,45.46427,{"lat":55,"lon":54},[58,59],{"name":34,"role":35,"phone":36,"phoneExt":10,"email":37},{"name":39,"role":35,"phone":40,"phoneExt":10,"email":41},{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Giovanni Peretto","MD, Principal Investigator","100561522","role-of-endomyocardial-biopsy-and-aetiology-based-treatment-in-pediatric-patients-with-inflammatory-heart-disease-in-arrhythmic-and-non-arrhythmic-clinical-presentations-an-integrated-approach-for-the-optimal-diagnostic-and-therapeutic-management-myoped-100561522",false,"NCT06591260","Role of Endomyocardial Biopsy and Aetiology-based Treatment in Pediatric Patients with Inflammatory Heart Disease in Arrhythmic and Non-arrhythmic Clinical Presentations: an Integrated Approach for the Optimal Diagnostic and Therapeutic Management (MYOPED)","Role of Endomyocardial Biopsy and Aetiology-based Treatment in Pediatric Patients with Inflammatory Heart Disease in Arrhythmic and Non-arrhythmic Clinical Presentations: an Integrated Approach for the Optimal Diagnostic and Therapeutic Management","MYOPED","Inclusion Criteria:\n\n* Written informed consent.\n* Age \\< 18 years.\n* Clinically suspected myocarditis.\n* Enrollment performed by one of the participating Centers.\n\nExclusion Criteria:\n\n* Absence of written informed consent.\n* Age \\> 18 years (adults)",true,"ALL","0 Years","17 Years",{"count":77,"type":78},20,"ESTIMATED","30 Years","OBSERVATIONAL","Myocarditis is a complex inflammatory disease, usually occurring secondary to viral infections, autoimmune processes or toxic agents. Clinical presentations are multiple, including chest-pain, heart failure and a broad spectrum of arrhythmias. In turn, outcome is largely unpredictable, ranging from mild self-limiting disease, to chronic stage and progressive evolution towards dilated cardiomyopathy, to rapid adverse outcome in fulminant forms. Subsequently, myocarditis is often underdiagnosed and undertreated, and optimal diagnostic and therapeutic strategies are still to be defined. This study, both retrospective and prospective, originally single-center and subsequently upgraded to multicenter, aims at answering multiple questions about myocarditis, with special attention to its arrhythmic manifestations.\n\nOptimal diagnostic workflow is still to be defined. In fact, although endomyocardial biopsy (EMB) is still the diagnostic gold standard, especially for aetiology identification, it is an invasive technique. Furthermore, it may lack sensitivity because of sampling errors. By converse, modern imaging techniques - cardiac magnetic resonance (CMR) in particular - have been proposed as alternative or complementary diagnostic tool in inflammatory heart disease. Other noninvasive diagnostic techniques, like delayed-enhanced CT (DECT) scan or position emission tomography (PET) scan, are under investigation.\n\nBiomarkers to identify myocarditis aetiology, predisposition, prognosis and response to treatment are still to be defined.\n\nArrhythmic myocarditis is largely underdiagnosed and uninvestigated. Importantly, myocarditis presenting with arrhythmias requires specific diagnostic, prognostic and therapeutic considerations. At the group leader hospital, which is an international referral center for ventricular arrhythmias management and ablation, a relevant number of patients with unexplained arrhythmias had myocarditis as underlying aetiology. The experience of a dedicated third-level center is going to be shared with other centers, to considerably improve knowledge and management of arrhythmic myocarditis.\n\nThe role of CMR, as well as alternative noninvasive imaging techniques, in defining myocarditis healing is a relevant issue. In particular, optimal timing for follow-up diagnostic reassessment is still to be defined, in patients with myocarditis at different inflammatory stages, either with or without aetiology-dependent treatment.\n\nUniformly-designed studies are lacking, to compare myocarditis among different patient subgroups, differing by variables like: clinical presentations, myocarditis stage, associated cardiac or extra-cardiac diseases, aetiology-based treatment, associated arrhythmic manifestations, diagnostic workup, and devices or ablation treatment.",[83,84,85,86,87,88,89,90,91],"Myocarditis","Ventricular Arrhythmia","Inflammatory Cardiomyopathy","Genetic Predisposition","Autoimmunity","Arrhythmia","Cardiomyopathies","Immunosuppresion","Catheter Ablation",[83,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107],"Ventricular arrhythmias","Arrhythmias","Arrhythmogenic inflammatory cardiomyopathy","Endomyocardial biopsy","Cardiac magnetic resonance","Ablation","Positron emission tomography","Electroanatomical mapping","Immunosuppressive therapy","Arrhythmic risk stratification","Genetic predisposition","Environment","Implantable cardioverter defibrillator","Implantable loop recorder","Multicenter","2024-09-11",{"date":110,"type":111},"2024-09-19","ACTUAL",{"date":113,"type":111},"2013-01-01",{"date":115,"type":78},"2030-12-31",{"name":5,"class":6},1]