[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539901":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":11,"centralContacts":15,"locations":24,"responsibleParty":45,"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":27,"whyStopped":10,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Sunnybrook Health Sciences Centre","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":10},"Patients with skin cancer eligible for dual ICI treatment.",null,[12],{"name":13,"affiliation":5,"role":14},"Christian Houbois, MD","PRINCIPAL_INVESTIGATOR",[16,20],{"name":13,"role":17,"phone":18,"phoneExt":10,"email":19},"CONTACT","(416) 480-6100","christian.houbois@sunnybrook.ca",{"name":21,"role":17,"phone":18,"phoneExt":22,"email":23},"Navpreet Sekhon, MB Bch BAO","85466","navpreet.sekhon@sri.utoronto.ca",[25],{"facility":26,"status":27,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Sunnybrook Health Sciences Center","RECRUITING","Toronto","Ontario","M4N 3M5","Canada","CA",{"type":34,"coordinates":35},"Point",[36,37],-79.39864,43.70643,{"lat":37,"lon":36},[40,44],{"name":41,"role":17,"phone":18,"phoneExt":42,"email":43},"Thayalasuthan Vivekanandan, MD","89291","thayalasuthan.vivekanandan@Sunnybrook.ca",{"name":21,"role":17,"phone":18,"phoneExt":22,"email":23},{"type":14,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Dr. Christian Houbois","Assistant Professor, MD","100539901","immune-checkpoint-inhibitor-therapy-for-cancer-and-risk-of-myocarditis-or-cardiomyopathy-100539901",false,"NCT06309862","Immune Checkpoint Inhibitor Therapy for Cancer and Risk of Myocarditis or Cardiomyopathy","Association of Immune Checkpoint Inhibitor Therapy for Cancer With Early Myocardial Tissue and Biomarker Changes During Treatment - Implication for Risk of Myocarditis and Cardiomyopathy","Inclusion Criteria:\n\n* All patients 18 years of age, or older, with skin cancer and eligible for ICI treatment with a combination of a) nivolumab, b) pembrolizumab, or c) ipilimumab.\n* Able to provide informed consent\n* Able to travel to SHSC for cardiac imaging.\n\nExclusion Criteria:\n\n* Life expectancy equal to, or less than, 12 months\n* Participating in another clinical trial\n* Treated with ICI in the past\n* History of cardiac disease (e.g. heart failure, myocardial infarction, atrial fibrillation, unstable angina)\n* Pregnant patients\n* Impaired renal function (GFR equal to, or less than, 30mL\u002Fmin)\n* Contraindications for MRI (e.g. pacemaker).","ALL","18 Years",{"count":58,"type":59},15,"ESTIMATED","OBSERVATIONAL","Patients undergoing dual treatment with Immune checkpoint inhibitors (ICI) for various cancers, e.g. melanoma, are at increased risk of developing myocarditis and cardiomyopathy. Currently, only limited data on serial myocardial tissue changes during treatment and whether they predict outcomes are available. Cardiac MRI (CMR) is the reference standard for non-invasive myocardial volumes\u002Ffunction analysis and uniquely characterizes myocardial tissue. Therefore, it may help detect myocardial tissue changes during treatment and help early treatment and prevent adverse cardiac outcomes.",[63,64],"Cardio-Oncology","Cardiomyopathy Due to Drug",[63,66,67,68,69],"Immunotherapy","Cardiomyopathy","Cardiac MRI","Myocardial tissue changes","2024-06-06",{"date":72,"type":73},"2024-06-07","ACTUAL",{"date":75,"type":59},"2024-06-01",{"date":77,"type":59},"2025-12-31",{"name":5,"class":6},1]