ICI associated cardiotoxicity
Conditions
Interventions
Group 1: Retrospective analysis of all patients with malignant melanoma who were treated with immune checkpoint inhibitor therapy at University Hospital Bonn between 2020 and 2024.
Sponsors
Universitätsklinikumm Bonn
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Confirmed diagnosis of malignant melanoma Treatment with at least one immune checkpoint inhibitor (ICI) (e.g. PD-1, PD-L1, or CTLA-4 inhibitors, as monotherapy or combination therapy) Treatment and follow-up at University Hospital Bonn Initiation of ICI therapy between January 2020 and September 2024 Availability of sufficient clinical data to calculate the CardTox Score (including age, left ventricular ejection fraction, and relevant cardiovascular comorbidities) At least one documented clinical follow-up after initiation of ICI therapy
Exclusion criteria
Exclusion criteria: Missing or incomplete baseline data precluding calculation of the CardTox Score Absence of documented follow-up after initiation of ICI therapy Presence of active myocarditis or acute decompensated heart failure prior to initiation of ICI therapy Concurrent participation in an interventional clinical trial with direct impact on cardiovascular outcomes Inability to use patient data in pseudonymized form due to legal or regulatory restrictions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is a composite of clinically relevant cardiovascular outcomes occurring during immune checkpoint inhibitor (ICI) therapy: ICI-associated myocarditis, diagnosed according to the 2022 ESC criteria, based on clinical presentation, elevated cardiac biomarkers, cardiac imaging (e.g. CMR with myocarditis-typical findings), or endomyocardial biopsy Hospitalization for heart failure, defined as admission with a primary diagnosis of acute or decompensated heart failure (ICD I50.x) and corresponding clinical and biomarker evidence Cardiovascular death, including death due to sudden cardiac death, myocardial infarction, or progressive heart failure | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints capture additional clinically meaningful events and follow-up outcomes: Hospitalization due to other severe cardiac events, such as malignant ventricular arrhythmias, high-grade atrioventricular block, or bradyarrhythmias requiring permanent pacemaker implantation End of the observation period, defined as the last documented clinical contact within the study timeframe All-cause mortality, defined as death from any cause during the observation period, irrespective of attribution | — |
Countries
Germany
Contacts
Public ContactCan Öztürk
Universitätklinikum Bonn
Outcome results
None listed