Integrated risk stratification for ICI-associated myocarditis: a baseline hematological profile and a combined ECG and enzymatic signature at onset

Background: Immune checkpoint inhibitor-associated myocarditis (ICI-associated myocarditis) is a rare but fatal immune-related adverse event. Early identification of high-risk patients remains challenging. This study aimed to identify risk factors and develop models for predicting both the occurrence and severity of ICI-associated myocarditis. Methods: This retrospective unmatched case-control study stratified patients receiving ICIs into ICI-associated myocarditis (stratified into mild and severe subgroups) and controls. Comparative analysis of baseline and onset-phase data was performed, with logistic regression used to identify risk factors for the development of ICI-associated myocarditis and the severe myocarditis. Results: = 0.043) and had higher rates of symptoms and concurrent immune-related adverse events. Conclusion: A baseline profile of elevated eosinophil ratio, reduced lymphocyte ratio, and elevated myoglobin collectively may help identify patients at risk for ICI-associated myocarditis. At myocarditis onset, a combination of specific electrocardiographic abnormalities and marked CK elevation may predict severe cases. These findings suggest a two-stage approach for early risk stratification and targeted management.