Arterial Thrombosis, Atherosclerosis, Cancer, Cardiovascular Diseases, Coronary Artery Disease, Myocardial Infarction, Stroke
Conditions
Keywords
immune checkpoint inhibitors, cardiovascular disease, atherosclerosis
Brief summary
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).
Interventions
DIAGNOSTIC_TESTCoronary computed tomography angiography (CCTA) at baseline
Detailed imaging of coronary arteries
DIAGNOSTIC_TESTCoronary computed tomography angiography (CCTA) after 1 year
Detailed imaging of coronary arteries
Sponsors
Amsterdam UMC
Hanneke W. M. van Laarhoven
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Known allergy to iodinated contrast agents * Atrial fibrillation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-calcified coronary plaque volume (difference between baseline and follow-up CT) | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plaque characteristics (differences between baseline and follow-up) | 1 year | Difference in plaque characteristics (i.e. fat attenuation index) |
| Differences in plasma biomarkers (pro-inflammatory markers) between baseline and follow-up | 3 months, 1 year | Immune cell composition, T cell composition, IL-1b, IL-6, NLRP3, IL-17, TNF-a, IFN-y |
| Incidence of Arterial thromboembolic event | 1 year, 5 years | Incidence of Arterial Thromboembolic events, defined as major cardiovascular events (MACE), including nonfatal ischemic stroke, nonfatal myocardial infarction and cardiovascular death |
Other
| Measure | Time frame |
|---|---|
| Venous thromboembolism | 1 year, 5 years |
Countries
Netherlands
Contacts
Primary ContactA Strijdhorst
Outcome results
None listed