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).
Study Type
OBSERVATIONAL
Enrollment
214
Detailed imaging of coronary arteries
Detailed imaging of coronary arteries
Amsterdam UMC
Amsterdam, North Holland, Netherlands
RECRUITINGNon-calcified coronary plaque volume (difference between baseline and follow-up CT)
Time frame: 1 year
Plaque characteristics (differences between baseline and follow-up)
Difference in plaque characteristics (i.e. fat attenuation index)
Time frame: 1 year
Differences in plasma biomarkers (pro-inflammatory markers) between baseline and follow-up
Immune cell composition, T cell composition, IL-1b, IL-6, NLRP3, IL-17, TNF-a, IFN-y
Time frame: 3 months, 1 year
Incidence of Arterial thromboembolic event
Incidence of Arterial Thromboembolic events, defined as major cardiovascular events (MACE), including nonfatal ischemic stroke, nonfatal myocardial infarction and cardiovascular death
Time frame: 1 year, 5 years
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