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RECRUITINGOBSERVATIONAL

Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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).

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DIAGNOSTIC_TEST

Coronary computed tomography angiography (CCTA) at baseline

Detailed imaging of coronary arteries

DIAGNOSTIC_TEST

Coronary computed tomography angiography (CCTA) after 1 year

Detailed imaging of coronary arteries

Locations (1)

Amsterdam UMC
Amsterdam, North Holland, Netherlands