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Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer

Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer

Recruiting
50 years and older
All
Phase N/A

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Overview

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

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

Study details
    Cardiovascular Diseases
    Arterial Thrombosis
    Myocardial Infarction
    Stroke
    Coronary Artery Disease
    Atherosclerosis
    Cancer

NCT06519292

Hanneke W. M. van Laarhoven

2 June 2025

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