RecruitingNCT06519292

Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer


Sponsor

Hanneke W. M. van Laarhoven

Enrollment

214 participants

Start Date

Jan 25, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This observational study is tracking heart-related side effects in people with certain cancers who are starting immunotherapy (checkpoint inhibitor drugs) or chemotherapy, to better understand who is at risk. **You may be eligible if...** - You are 50 or older - You have been diagnosed with esophageal, stomach, colorectal, lung (non-small cell), melanoma, or kidney cancer at any stage - You are about to start a new treatment (immunotherapy, chemotherapy, or monitoring) **You may NOT be eligible if...** - You received immunotherapy (checkpoint inhibitor) within the past 12 months - You currently have an active infection (viral, bacterial, or fungal) - You have atrial fibrillation (an irregular heartbeat) - Your kidneys are not functioning well (low eGFR) - You are allergic to iodinated contrast dye - You are currently taking immunosuppressive medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(1)

Amsterdam UMC

Amsterdam, North Holland, Netherlands

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NCT06519292


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