NCT06519292 Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer
| NCT ID | NCT06519292 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hanneke W. M. van Laarhoven |
| Condition | Cardiovascular Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 214 participants |
| Start Date | 2023-01-25 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 214 participants in total. It began in 2023-01-25 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
H.W.M. van Laarhoven, Prof. Dr.
PRINCIPAL INVESTIGATOR
secretariaat.oncologie@amsterdamumc.nl
Frequently Asked Questions
Who can join the NCT06519292 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Cardiovascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06519292 currently recruiting?
Yes, NCT06519292 is actively recruiting participants. Contact the research team at a.strijdhorst@amsterdamumc.nl for enrollment information.
Where is the NCT06519292 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT06519292 clinical trial?
NCT06519292 is sponsored by Hanneke W. M. van Laarhoven. The principal investigator is H.W.M. van Laarhoven, Prof. Dr. at secretariaat.oncologie@amsterdamumc.nl. The trial plans to enroll 214 participants.