Trials / Recruiting

RecruitingNCT06519292

Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer

Status: Recruiting
Phase: —
Study type: Observational
Enrollment: 214 (estimated)

Sponsor: Hanneke W. M. van Laarhoven · Academic / Other
Sex: All
Age: 50 Years
Healthy volunteers: Not accepted

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).

Conditions

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Coronary computed tomography angiography (CCTA) at baseline	Detailed imaging of coronary arteries
DIAGNOSTIC_TEST	Coronary computed tomography angiography (CCTA) after 1 year	Detailed imaging of coronary arteries

Timeline

Start date: 2023-01-25
Primary completion: 2025-12-31
Completion: 2025-12-31
First posted: 2024-07-25
Last updated: 2025-05-22

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT06519292. Inclusion in this directory is not an endorsement.