[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643179":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":26,"studyPopulation":27,"armGroups":22,"interventions":22,"overallOfficials":22,"centralContacts":28,"locations":34,"responsibleParty":49,"collaborators":53,"id":56,"slug":22,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":22,"maxAge":22,"enrollmentInfo":64,"targetDuration":22,"studyType":67,"phases":22,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":37,"whyStopped":22,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Groupe Hospitalier Pitie-Salpetriere","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"All-cause mortality at 90 days after ICI-M presentation\u002Findex date","Death from any cause within 90 days of ICI-M presentation\u002Findex date, analysed in relation to immunosuppressive treatment strategy and adjusted for prespecified confounders. Treatment and selected clinical variables may be handled as time-dependent covariates.","90 days from ICI-M presentation\u002Findex date",[14,18],{"measure":15,"description":16,"timeFrame":17},"All-cause mortality at 30 days and 360 days after ICI-M presentation\u002Findex date","Mortality (with cause-specific approach) at early and longer follow-up horizons; compare overall and sensitivity models across imputation approaches, handling of competitive risks and time-dependent-covariate strategies.","30 days and 360 days from ICI-M presentation\u002Findex date",{"measure":19,"description":20,"timeFrame":21},"Modification of treatment-mortality association by myocarditis severity","Interaction\u002Fsensitivity analyses evaluating whether myocarditis severity modifies the association between glucocorticoid or not and second-line immunosuppressive strategies and mortality outcomes.","Up to 360 days from ICI-M presentation\u002Findex date",null,{"allocation":22,"interventionModel":22,"interventionModelDescription":22,"primaryPurpose":22,"observationalModel":24,"timePerspective":25,"maskingInfo":22},"COHORT","RETROSPECTIVE","\"ATROPOS (Assessing lethaliTy and Risk factOrs in immune checkPoint inhibitors-induced myOcardia survival analysis based on an international registry) is an observational, non-interventional analysis of the international REDCap registry of immune checkpoint inhibitor-associated myocarditis (ICI-M).\n\nThe study population consists of cancer patients exposed to immune checkpoint inhibitors and recorded in the registry with possible, probable, or definite ICI-M according to registry\u002Fadjudication definitions. The main objective is to evaluate associations between immunosuppressive treatment strategies and overall mortality, as a function of myocarditis severity, focusing on first-line glucocorticoids and the subsequent use of second-line immunosuppressants. The study will also assess whether these associations are modified by myocarditis severity. Secondary analyses will examine mortality at 30, 90 and 360 days, cause-specific death (e.g. myotoxicity, cancer-related) where available, and clinical risk factors related to oncology history, ICI exposure, symptoms, ECG, echocardiography, cardiac MRI, biomarkers including CK and troponin, other immune-related adverse events, heart failure, respiratory muscle failure, arrhythmias and conductive disorders, sepsis, and pharmacological treatments.\n\nThe statistical approach will include descriptive analyses and Cox proportional-hazards modelling. Time-dependent covariates will be considered for variables such as troponin, left ventricular ejection fraction, severity\u002Fgrade of the myocarditis\u002Fmyotoxicity, glucocorticoids and other immunosuppressants. Missing data will be described and handled through prespecified methods, with MICE and JointAI used to cross-check robustness of results. Because treatment strategies are not assigned by the protocol, all treatment-effect analyses will be interpreted as observational associations, adjusted for prespecified clinical confounders.\n\nATROPOS does not assign study treatment, change patient management, require extra visits, or involve a study drug\u002Fdevice. The central analysis dataset uses coded or pseudonymised data, with direct identifiers retained only by local sites when applicable under their own governance.\"","Cancer patients exposed to immune checkpoint inhibitors and recorded in a REDCap international ICI-Myocarditis registry, including cases with clinical, biomarker, ECG, imaging, treatment, complication and mortality\u002Foutcome data sufficient for the planned survival analyses.",[29],{"name":30,"role":31,"phone":32,"phoneExt":22,"email":33},"Joe-Elie Salem, MD-PhD","CONTACT","0033142178531","joe-elie.salem@aphp.fr",[35],{"facility":36,"status":37,"city":38,"state":22,"zip":22,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Hopital Pitie-Salpetriere \u002F CIC-2503","RECRUITING","Paris","France","FR",{"type":42,"coordinates":43},"Point",[44,45],2.3488,48.85341,{"lat":45,"lon":44},[48],{"name":30,"role":31,"phone":32,"phoneExt":22,"email":33},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Joe Elie Salem","Clinical Professor, Clinical Investigation Center Paris Est",[54],{"name":55,"class":6},"Vanderbilt University Medical Center","100643179",false,"NCT07633587","ATROPOS: Survival Analysis of ICI-associated Myocarditis","ATROPOS: Assessing morTality and Risk factOrs in Immune checkPoint Inhibitor-induced myotOxicities: a Survival Analysis Based on an International Registry","ATROPOS","Inclusion Criteria:\n\n* cancer patients exposed to at least one immune checkpoint inhibitor\n* possible, probable or definite immune checkpoint inhibitor-associated myocarditis recorded in the international registry according to registry\u002Fadjudication definitions\n* available index-date\u002Fpresentation information\n* available mortality follow-up.\n\nExclusion Criteria:\n\n* duplicate records\n* not enough data to classify as myocarditis\n* record\u002Fpatient withdrawn from research use unresolved data-quality issues preventing inclusion in the final SAP-defined analysis set.","ALL",{"count":65,"type":66},1500,"ESTIMATED","OBSERVATIONAL","ATROPOS is an international, registry-based observational study of cancer patients with immune checkpoint inhibitor-associated myocarditis (ICI-M). The study evaluates whether immunosuppressive treatment strategies, including first-line glucocorticoids and subsequent second-line immunosuppressants, are associated with overall mortality, and whether these associations vary according to myocarditis severity. The target number of cases to be included is 1500 spanning from at least 160 centers, located in at least 18 countries. Analyses will adjust for clinically relevant confounders and may use time-dependent survival models where appropriate.",[70],"Immune Checkpoint Inhibitor-associated Myocarditis",[72,73,74,75,76],"immune checkpoint inhibitors","myocarditis","mortality","REDCap","myotoxicity","2026-06-08",{"date":79,"type":80},"2026-06-10","ACTUAL",{"date":82,"type":80},"2026-05-20",{"date":84,"type":66},"2027-10-01",{"name":5,"class":6},1]