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| Name | Class |
|---|---|
| Amsterdam UMC | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICI group | Patients that receive immune checkpoint inhibitors |
| |
| Non-ICI group | Patients with similar malignancies, who do not receive immune checkpoint inhibitors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary computed tomography angiography (CCTA) at baseline | Diagnostic Test | Detailed imaging of coronary arteries |
|
| Measure | Description | Time Frame |
|---|---|---|
| Non-calcified coronary plaque volume (difference between baseline and follow-up CT) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque characteristics (differences between baseline and follow-up) | Difference in plaque characteristics (i.e. fat attenuation index) | 1 year |
| Differences in plasma biomarkers (pro-inflammatory markers) between baseline and follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Venous thromboembolism | 1 year, 5 years |
Inclusion Criteria:
Exclusion Criteria:
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Adult male or female subjects are eligible for study participation if they have a confirmed cancer diagnosis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| A Strijdhorst | Contact | +31 205665975 | a.strijdhorst@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| H.W.M. van Laarhoven, Prof. Dr. | secretariaat.oncologie@amsterdamumc.nl | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Recruiting | Amsterdam | North Holland | 1105AZ | Netherlands |
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Plasma, serum and PBMC
| Coronary computed tomography angiography (CCTA) after 1 year | Diagnostic Test | Detailed imaging of coronary arteries |
|
Immune cell composition, T cell composition, IL-1b, IL-6, NLRP3, IL-17, TNF-a, IFN-y
| 3 months, 1 year |
| Incidence of Arterial thromboembolic event | Incidence of Arterial Thromboembolic events, defined as major cardiovascular events (MACE), including nonfatal ischemic stroke, nonfatal myocardial infarction and cardiovascular death | 1 year, 5 years |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D009203 | Myocardial Infarction |
| D020521 | Stroke |
| D003324 | Coronary Artery Disease |
| D050197 | Atherosclerosis |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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