Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer

Recruiting

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

• 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, this study evaluates the effect of ICI on progression of coronary non-calcifid plaque volume by using computed tomography angiography (CCTA).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-25
• Study First Submitted: 2024-07-18
• Study First Submitted QC: 2024-07-24
• Study First Posted: 2024-07-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-22
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 214

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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
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	Immune cell composition, T cell composition, IL-1b, IL-6, NLRP3, IL-17, TNF-a, IFN-y
Incidence of Arterial thromboembolic event	1 year, 5 years	Incidence of Arterial Thromboembolic events, defined as major cardiovascular events (MACE), including nonfatal ischemic stroke, nonfatal myocardial infarction and cardiovascular death

Trial Locations

Locations (1)

Amsterdam UMC; 🇳🇱 Amsterdam, Noord-Holland, Netherlands