NCT06519292Recruiting
Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer
Source: ClinicalTrials.gov · Last updated 22 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 214 (estimated)
- First submitted
- 18 Jul 2024
- Start date
- 25 Jan 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Hanneke W. M. van Laarhoven
- Diseases
- Coronary artery disease, Stroke
- NCT number
- NCT06519292
What you commit to
- Study type: Observational
- Planned participants: 214
- From 25 Jan 2023 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- ICI therapy in previous 12 months
- Use of immunosuppressive therapy prior to ICI start
Other illness
- Suspected or confirmed viral, fungal, or bacterial infectious disease
- Known allergy to iodinated contrast agents
Lab values
- Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2
Other
- Atrial fibrillation
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.