Clinical Research Directory

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

Sponsor: South Tees Hospitals NHS Foundation Trust

Summary

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.

Official title: Prospective Study of Cardiac Biomarker Elevation in Patients Receiving Immune Checkpoint Inhibitors

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