Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer
- Conditions
- Myocardial InfarctionArterial ThrombosisStrokeAtherosclerosisCancerCardiovascular DiseasesCoronary Artery Disease
- Interventions
- Diagnostic Test: Coronary computed tomography angiography (CCTA) at baselineDiagnostic Test: Coronary computed tomography angiography (CCTA) after 1 year
- Registration Number
- NCT06519292
- Lead Sponsor
- Hanneke W. M. van Laarhoven
- 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, we assess the effect of ICI on progression of coronary non-calcifid plaque volume by using computed tomography angiography (CCTA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 214
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non-ICI group Coronary computed tomography angiography (CCTA) after 1 year Patients with similar malignancies, who do not receive immune checkpoint inhibitors ICI group Coronary computed tomography angiography (CCTA) after 1 year Patients that receive immune checkpoint inhibitors Non-ICI group Coronary computed tomography angiography (CCTA) at baseline Patients with similar malignancies, who do not receive immune checkpoint inhibitors ICI group Coronary computed tomography angiography (CCTA) at baseline Patients that receive immune checkpoint inhibitors
- Primary Outcome Measures
Name Time Method Non-calcified coronary plaque volume (difference between baseline and follow-up CT) 1 year
- Secondary Outcome Measures
Name Time Method Arterial thromboembolic event 1 year, 5 years Gut microbiota composition (difference between baseline and follow-up) 1 year Plaque characteristics (differences between baseline and follow-up) 1 year Difference in plaque characteristics (i.e. fat attenuation index)
Differences in plasma biomarkers (pro-inflammatory markers) between baseline and follow-up 3 months, 1 year
Trial Locations
- Locations (1)
Amsterdam UMC
🇳🇱Amsterdam, Noord-Holland, Netherlands