[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578965":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":30,"responsibleParty":44,"collaborators":10,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":10,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":10,"enrollmentInfo":57,"targetDuration":10,"studyType":60,"phases":10,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Shanghai Chest Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Severe\u002Fcritical group",null,"Severe Type:\n\nSignificant symptoms (e.g., fatigue, palpitations, chest pain) triggered by daily activities without hemodynamic changes; elevated myocardial biomarkers (Cardiac troponin, creatine kinase, Creatine kinase myocardial band, Aspartate aminotransferase，natriuretic peptides); new ECG changes; structural and functional myocardial abnormalities on echocardiography or MRI.\n\nCritical Type:\n\nIntolerable symptoms (e.g., respiratory dysfunction, heart failure, cardiogenic shock) at rest or minimal activity, with hemodynamic instability; significantly elevated myocardial biomarkers (Cardiac troponin, creatine kinase, Creatine kinase myocardial band, Aspartate aminotransferase, natriuretic peptides); severe myocardial structural and functional abnormalities on echocardiography or MRI; new severe arrhythmias on ECG .",[13],"Diagnostic Test: Biomarker Analysis for Severity Assessment",{"label":15,"type":10,"description":16,"interventionNames":17},"Subclinical myocardial injury\u002Fmild group","Subclinical Myocardial Injury: All three of the following criteria must be met:\n\n1. No clinical symptoms triggered by daily activities;\n2. Only mild elevation of Cardiac troponin levels without elevation of other myocardial injury biomarkers;\n3. No abnormalities detected in other auxiliary examinations.\n\nMild Type: The following conditions must be met for diagnosis:\n\n1. Daily activities may cause mild, nonspecific symptoms such as fatigue or shortness of breath;\n2. Mild elevation of myocardial injury biomarkers (Cardiac troponin, creatine kinase, Creatine kinase myocardial band, Aspartate aminotransferase，natriuretic peptides);\n3. Mild abnormalities on ECG, including new-onset sinus tachycardia, atrial arrhythmias, or nonspecific ST-T changes;\n4. No structural or functional abnormalities of the myocardium detected by echocardiography or cardiac MRI.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DIAGNOSTIC_TEST","Biomarker Analysis for Severity Assessment","Blood samples will be collected at baseline and at follow-up time points (3 days, 7 days, and before discharge). Traditional myocardial injury biomarkers, iron metabolism-related biomarkers, and immunological biomarkers will be tested.",[9,15],[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Yanbin Kuang, PhD","CONTACT","+86 021-22200000","kybkyb2@163.com",[31],{"facility":5,"status":32,"city":33,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"RECRUITING","Shanghai","China","CN",{"type":37,"coordinates":38},"Point",[39,40],121.45806,31.22222,{"lat":40,"lon":39},[43],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Yanbin Kuang","Attending Physician,PhD","100578965","biomarkers-for-clinical-classification-and-outcomes-of-immune-checkpoint-inhibitor-related-related-myocarditis-in-lung-cancer-100578965",false,"NCT06818149","Biomarkers for Clinical Classification and Outcomes of Immune Checkpoint Inhibitor-Related-Related Myocarditis in Lung Cancer","A Study on the Clinical Classification and Outcome-Related Biological Markers of Immune Checkpoint Inhibitor-Related Myocarditis in Lung Cancer Patients","Inclusion Criteria:\n\n* Pathologically confirmed lung cancer and having received at least one dose of immune checkpoint inhibitor therapy;\n* Clinically diagnosed with immune checkpoint inhibitor-related myocarditis;\n* Aged 18 years or older;\n* Voluntarily signed informed consent after being fully informed.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding;\n* Presence of severe underlying cardiovascular diseases or recent acute cardiac events (e.g., myocardial infarction, severe arrhythmia);\n* Concurrent other malignancies, immunosuppressive diseases, or autoimmune diseases;\n* Inability to complete the required examinations and follow-ups specified in the study.","ALL","18 Years",{"count":58,"type":59},50,"ESTIMATED","OBSERVATIONAL","This study aims to investigate the clinical classification and outcome-related biomarkers of immune checkpoint inhibitor (ICI)-related myocarditis in patients with lung cancer.A total of 50 patients with ICI-related myocarditis will be enrolled, including 25 with severe\u002Fcritical myocarditis and 25 with subclinical\u002Fmild myocarditis. Blood samples will be collected at baseline and at follow-up time points (3 days, 7 days, and before discharge). Traditional myocardial injury markers, iron metabolism-related markers, and immunological markers will be measured and compared between groups. Changes in biomarkers after treatment will also be assessed. Clinical information such as in-hospital mortality and 3-month survival rates will be integrated to develop a severity assessment model. This model aims to evaluate disease severity and prognostic risk accurately by combining biomarkers, enhancing their application in clinical management.",[63,64],"Lung Cancer","Myocarditis Due to Drug",[63,66,67],"Myocarditis","Immune Checkpoint Inhibitors","2025-02-05",{"date":70,"type":71},"2025-02-10","ACTUAL",{"date":73,"type":59},"2025-01-30",{"date":75,"type":59},"2028-12-30",{"name":5,"class":6},1]