Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer (ITHACA)

Hanneke W. M. van Laarhoven

Status: Enrolling

Conditions: Coronary Artery Disease; Stroke; Myocardial Infarction; Cardiovascular Diseases; Cancer; Arterial Thrombosis; Atherosclerosis

Treatments: Diagnostic Test: Coronary computed tomography angiography (CCTA) at baseline; Diagnostic Test: Coronary computed tomography angiography (CCTA) after 1 year

Study type: Observational

Funder types: Other

Identifiers

NCT06519292

NL82446.018.22

Details and patient eligibility

About

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).

Enrollment: 214 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

214 participants in 2 patient groups

ICI group

Description:

Patients that receive immune checkpoint inhibitors

Treatment:

Diagnostic Test: Coronary computed tomography angiography (CCTA) after 1 year

Diagnostic Test: Coronary computed tomography angiography (CCTA) at baseline

Non-ICI group

Description:

Patients with similar malignancies, who do not receive immune checkpoint inhibitors

Treatment:

Diagnostic Test: Coronary computed tomography angiography (CCTA) after 1 year

Diagnostic Test: Coronary computed tomography angiography (CCTA) at baseline