Cardiac Biomarkers in Patients Receiving Immune Checkpoint Inhibitors (PRIME-ICI)

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.

Inclusion Criteria: * Adults aged 18 years or older. * Planned to start any immune checkpoint inhibitor-containing treatment (PD-1, PD-L1, CTLA-4 or combination therapy). * Enrolled at, or immediately prior to, ICI initiation, with residual blood available from routine clinical sampling where feasible. * Provision of informed consent. Exclusion Criteria: * Recent acute coronary syndrome within 1 month prior to enrolment. * Dialysis-dependent renal failure (patients with non-dialysis chronic kidney disease may be included and eGFR recorded).