Heart and blood vessel side effects of immune checkpoint cancer drugs
Studies heart artery plaque changes with CT scans in cancer patients on immunotherapy.
Key facts
- Who runs it
- Hanneke W. M. van Laarhoven
- Where
- Amsterdam, NetherlandsSee the site
- Trial code
- Registry title
- Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer
- Status
- Recruiting
- People taking part
- 214 people, planned
- Started
- 25 Jan 2023
- Planned end
- 31 Dec 2025
- Type of study
- Observational, 2 groups
- Treatments tested
- Coronary computed tomography angiography (CCTA) at baseline
- Coronary computed tomography angiography (CCTA) after 1 year
- Record updated
- 22 May 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 50 or older with certain cancers who are about to start a new cancer treatment. It studies how immune checkpoint inhibitors affect heart artery plaque.
- Age
- 50 years or older
- Sex
- All sexes can join
- Disease stage
- Confirmed esophageal, gastric or junction cancer, colorectal cancer, non-small cell lung carcinoma, melanoma or renal cell carcinoma, any stage
- Earlier treatment
- Must not have had immune checkpoint inhibitor therapy in the previous 12 months. Must be before the start of a new therapy (immune checkpoint inhibitor, chemotherapy, or follow-up for esophageal cancer).
Main reasons for not taking part
- Immune checkpoint inhibitor therapy in the previous 12 months
- Suspected or confirmed viral, fungal or bacterial infection
- Immunosuppressive therapy before immune checkpoint inhibitor start
- Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2
- Known allergy to iodinated contrast agents or atrial fibrillation
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- ICI therapy in previous 12 months
- Use of immunosuppressive therapy prior to ICI start
- Suspected or confirmed viral, fungal, or bacterial infectious disease
- Known allergy to iodinated contrast agents
- Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2
- Atrial fibrillation
Where in Netherlands
- Amsterdam UMCAmsterdam, NetherlandsContact: A StrijdhorstTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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).
The 2 groups in the trial
- ICI group
Patients that receive immune checkpoint inhibitors
Treatment: Coronary computed tomography angiography (CCTA) at baseline and Coronary computed tomography angiography (CCTA) after 1 year
- Non-ICI group
Patients with similar malignancies, who do not receive immune checkpoint inhibitors
Treatment: Coronary computed tomography angiography (CCTA) at baseline and Coronary computed tomography angiography (CCTA) after 1 year
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer
- Plain-language title
- Heart and blood vessel side effects of immune checkpoint cancer drugsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 22 May 2025