[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659473":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":33,"studyPopulation":34,"armGroups":35,"interventions":29,"overallOfficials":39,"centralContacts":43,"locations":49,"responsibleParty":64,"collaborators":29,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":29,"enrollmentInfo":76,"targetDuration":29,"studyType":79,"phases":29,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":90,"whyStopped":29,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"South Tees Hospitals NHS Foundation Trust","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":29},[9,13],{"measure":10,"description":11,"timeFrame":12},"Number of participants with cardiac biomarker elevation across evaluable biomarker episodes","Proportion of evaluable routine-treatment and acute admission\u002FED observation biomarker episodes in which NT-proBNP, hs-cTnI and\u002For hs-cTnT is above the applicable local laboratory upper limit of normal. Estimates will be reported with 95% confidence intervals.","From baseline\u002FICI initiation through a minimum of 6 months follow-up",{"measure":14,"description":15,"timeFrame":12},"Adjudicated clinical phenotype of biomarker-positive episodes","Distribution of biomarker-positive episodes across prespecified adjudicated phenotypes: ICI-associated myocarditis; heart failure\u002Fcongestion; acute coronary syndrome\u002Fischaemic myocardial injury; other cardiovascular illness; non-cardiovascular\u002Fsystemic illness; and indeterminate\u002Fnot assessable.",[17,20,23,26],{"measure":18,"description":19,"timeFrame":12},"Distribution of prespecified biomarker patterns","Number and proportion of biomarker-positive episodes classified as isolated NT-proBNP elevation, isolated troponin elevation, combined NT-proBNP\u002Ftroponin elevation, or cardiac biomarker elevation accompanied by systemic\u002Fimmune-toxicity biomarker abnormalities.",{"measure":21,"description":22,"timeFrame":12},"Classification against ICI-myocarditis diagnostic frameworks","Among biomarker-positive episodes with sufficient contemporaneous data, number\u002Fproportion meeting ESC\u002FIC-OS criteria for ICI-associated myocarditis and description against locally implemented UKONS diagnostic\u002Fescalation thresholds. Episodes lacking sufficient data will be reported as not assessable.",{"measure":24,"description":25,"timeFrame":12},"Exploratory systemic biomarker abnormalities associated with cardiac biomarker elevation","Prevalence and magnitude of CK, ALT, AST and LDH abnormalities, together with available routine inflammatory, haematological and renal markers, in relation to cardiac biomarker elevation and adjudicated clinical phenotype.",{"measure":27,"description":28,"timeFrame":12},"Trajectory of cardiac biomarker abnormalities","Among episodes with biomarker elevation, subsequent available values will be used to describe whether levels normalise, improve, persist or worsen, and where possible the trajectory will be described in relation to clinical context, cardiovascular therapy, immunosuppression, ICI interruption and admission diagnosis.",null,{"allocation":29,"interventionModel":29,"interventionModelDescription":29,"primaryPurpose":29,"observationalModel":31,"timePerspective":32,"maskingInfo":29},"COHORT","PROSPECTIVE","PRIME-ICI is a single-centre prospective observational cohort study enrolling adults at, or immediately prior to, the start of an immune checkpoint inhibitor-containing treatment regimen. Patients already established on ICI therapy are not recruited, in order to reduce survivorship and selection bias. Participants are followed through review of the electronic patient record for a minimum of 6 months.\n\nThe study primarily uses residual blood remaining after routine clinical testing. Residual samples obtained before ICI initiation, at available routine ICI\u002FSACT treatment visits, and during acute hospital admissions or emergency-department observation episodes are identified where feasible and stored for later batch analysis. If no suitable residual baseline sample remains, one additional small baseline research blood sample may be taken at the first ICI treatment visit in accordance with the approved consent process.\n\nThe primary cardiac biomarkers are NT-proBNP, high-sensitivity cardiac troponin T (hs-cTnT), and high-sensitivity cardiac troponin I (hs-cTnI). Exploratory biomarkers include creatine kinase, alanine aminotransferase, aspartate aminotransferase and lactate dehydrogenase where sufficient sample is available and testing is analytically feasible. Contemporaneous routine clinical laboratory and clinical data are also collected where available.\n\nBiomarker-positive episodes are described according to prespecified biomarker patterns and undergo structured clinical review using available routine clinical data. Adjudicated phenotypes include ICI-associated myocarditis, heart failure\u002Fcongestion, acute coronary syndrome or ischaemic myocardial injury, other cardiovascular illness, non-cardiovascular\u002Fsystemic illness, and indeterminate\u002Fnot assessable. Where sufficient information is available, episodes are evaluated against ESC\u002FIC-OS criteria for ICI-associated myocarditis and locally implemented UKONS thresholds. The study is designed to characterise background biomarker elevation and its clinical context; it is not powered to determine myocarditis incidence or diagnostic sensitivity\u002Fspecificity.","Adults with cancer treated at The James Cook University Hospital who are planned to start an immune checkpoint inhibitor-containing regimen and are enrolled at, or immediately prior to, ICI initiation. Patients already established on ICI therapy are not recruited.",[36],{"label":37,"type":29,"description":38,"interventionNames":29},"Adults initiating immune checkpoint inhibitor therapy","Adults aged 18 years or older enrolled at, or immediately prior to, initiation of any ICI-containing treatment regimen at The James Cook University Hospital. Participants receive cancer treatment according to routine clinical care; the study does not assign treatment.",[40],{"name":41,"affiliation":5,"role":42},"David Austin, MD","PRINCIPAL_INVESTIGATOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":29,"email":48},"Saif Memon, MBBS","CONTACT","+44 (0)1642 850 850","saif.memon@nhs.net",[50],{"facility":51,"status":29,"city":52,"state":29,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Academic Cardiovascular Unit, James Cook University Hospital","Middlesbrough","TS4 3BW","United Kingdom","UK",{"type":57,"coordinates":58},"Point",[59,60],-1.23483,54.57623,{"lat":60,"lon":59},[63],{"name":45,"role":46,"phone":47,"phoneExt":29,"email":48},{"type":65,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100659473","cardiac-biomarkers-in-patients-receiving-immune-checkpoint-inhibitors-prime-ici-100659473",false,"NCT07864727","Cardiac Biomarkers in Patients Receiving Immune Checkpoint Inhibitors (PRIME-ICI)","Prospective Study of Cardiac Biomarker Elevation in Patients Receiving Immune Checkpoint Inhibitors","PRIME-ICI","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Planned to start any immune checkpoint inhibitor-containing treatment (PD-1, PD-L1, CTLA-4 or combination therapy).\n* Enrolled at, or immediately prior to, ICI initiation, with residual blood available from routine clinical sampling where feasible.\n* Provision of informed consent.\n\nExclusion Criteria:\n\n* Recent acute coronary syndrome within 1 month prior to enrolment.\n* Dialysis-dependent renal failure (patients with non-dialysis chronic kidney disease may be included and eGFR recorded).","ALL","18 Years",{"count":77,"type":78},300,"ESTIMATED","OBSERVATIONAL","Immune checkpoint inhibitors (ICIs) are widely used cancer treatments. Blood tests such as cardiac troponin and N-terminal pro-B-type natriuretic peptide (NT-proBNP) can help clinicians investigate possible heart injury, but these markers may also be raised for other reasons such as infection, kidney dysfunction, arrhythmia, pulmonary embolism or fluid overload. PRIME-ICI is a prospective observational study of adults starting ICI therapy at The James Cook University Hospital. The study will mainly use leftover blood from routine clinical samples and routine electronic health-record data. Samples will be batch tested for NT-proBNP, high-sensitivity troponin I and T, and selected exploratory biomarkers. The study will determine how often cardiac biomarkers are elevated, describe the clinical circumstances in which elevations occur, and classify biomarker-positive episodes according to their most likely clinical phenotype. Participation does not alter cancer treatment, and research biomarker results are not used for real-time clinical decisions.",[82,83,84],"Cardiotoxicity","Cardiac Biomarkers","Cancer",[86,87,88,89],"immune checkpoint inhibitor","cardio-oncology","cardiac troponin","ICI myocarditis","NOT_YET_RECRUITING","2026-10-02",{"date":93,"type":94},"2026-10-08","ACTUAL",{"date":96,"type":78},"2026-10-12",{"date":98,"type":78},"2028-03-31",{"name":5,"class":6},1]