About this trial
Immune checkpoint inhibitors (ICI) have revolutionized cancer treatment and are now approved for various types of cancer. The most common side effects of ICI are immune-related adverse events which can affect any organ or system in the body. Recently, concerns have also risen about cardiovascular effects of ICI. Retrospective studies showed an 4-5 times increased risk of developing an arterial thromboembolic event.
The mechanisms driving the ICI-associated risks of arterial thromboembolic events such as myocardial infarction and stroke, are unclear. Since the risk of a thromboembolism appears to be increased already during the first months after initiation of ICI, immune-related hypercoagulability or (autoimmune) antiphospholipid antibodies may play a role, but data to support this are lacking. The longer-term risk of arterial thromboembolism may be predominantly driven by (accelerated) atherosclerosis, a chronic low-grade inflammatory disease of the larger arteries. Therefore, this study evaluates the effect of ICI on progression of coronary non-calcifid plaque volume by using computed tomography angiography (CCTA).
Eligibility criteria
Qualifiers
Patients with confirmed diagnosis of the following tumor types, any stage: esophageal, gastric or junction cancer, colorectal cancer, non-small cell lung carcinoma, melanoma, renal cell carcinoma
Prior to start of new therapy (i.e. immune checkpoint inhibitor, chemotherapy or follow-up in case of esophageal cancer)
Age ≥ 50 years
Disqualifiers
ICI therapy in previous 12 months
Suspected or confirmed viral, fungal, or bacterial infectious disease
Use of immunosuppressive therapy prior to ICI start
Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2
Trial design
Treatments tested in this trial
- Coronary computed tomography angiography (CCTA) at baseline
- Coronary computed tomography angiography (CCTA) after 1 year
Treatment groups
Sponsors and collaborators
Hanneke W. M. van Laarhoven
Lead sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor institution
Amsterdam UMC
Collaborator