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RECRUITING
NCT06519292

Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer

Sponsor: Hanneke W. M. van Laarhoven

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

OBSERVATIONAL

Enrollment

214

Start Date

2023-01-25

Completion Date

2025-12-31

Last Updated

2025-05-22

Healthy Volunteers

No

Interventions

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