Actively Recruiting
Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer
Led by Hanneke W. M. van Laarhoven · Updated on 2025-05-22
214
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
Sponsors
H
Hanneke W. M. van Laarhoven
Lead Sponsor
A
Amsterdam UMC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with esophageal, gastric, junction, colorectal, non-small cell lung cancer, melanoma, or renal cell carcinoma at any stage
- Starting new therapy with immune checkpoint inhibitors, chemotherapy, or follow-up for esophageal cancer
- Age 50 years or older
You will not qualify if you...
- Immune checkpoint inhibitor therapy in the previous 12 months
- Suspected or confirmed viral, fungal, or bacterial infection
- Use of immunosuppressive therapy before starting immune checkpoint inhibitors
- Estimated kidney function (eGFR) less than 30 mL/min/1.73m2
- Known allergy to iodinated contrast agents
- History of atrial fibrillation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Amsterdam UMC
Amsterdam, North Holland, Netherlands, 1105AZ
Actively Recruiting
Research Team
A
A Strijdhorst
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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