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Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer

RECRUITINGSponsored by Hanneke W. M. van Laarhoven
Actively Recruiting
SponsorHanneke W. M. van Laarhoven
Started2023-01-25
Est. completion2025-12-31
Eligibility
Age50 Years+
Healthy vol.Accepted

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).

Eligibility

Age: 50 Years+Healthy volunteers accepted
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

Conditions8

Arterial ThrombosisAtherosclerosisCancerCardiovascular DiseasesCoronary Artery DiseaseHeart DiseaseMyocardial InfarctionStroke

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