Clinical trial · Observational
Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arterial Thrombosis | — | UNRESOLVED | — |
| Atherosclerosis | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cardiovascular Diseases | — | UNRESOLVED | — |
| Coronary Artery Disease | — | UNRESOLVED | — |
| Myocardial Infarction | — | UNRESOLVED | — |
| Stroke | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Coronary computed tomography angiography (CCTA) after 1 year | Diagnostic Test | — | UNRESOLVED |
| Coronary computed tomography angiography (CCTA) at baseline | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- ICI group
- description
- Patients that receive immune checkpoint inhibitors
- interventionNames
- Diagnostic Test: Coronary computed tomography angiography (CCTA) at baseline
- Diagnostic Test: Coronary computed tomography angiography (CCTA) after 1 year
- label
- Non-ICI group
- description
- Patients with similar malignancies, who do not receive immune checkpoint inhibitors
- interventionNames
- Diagnostic Test: Coronary computed tomography angiography (CCTA) at baseline
- Diagnostic Test: Coronary computed tomography angiography (CCTA) after 1 year
Primary outcomes (1)
- measure
- Non-calcified coronary plaque volume (difference between baseline and follow-up CT)
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available