MedDataX Logo

Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer

NCT06519292 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 214

Last updated 2025-05-22

No results posted yet for this study

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

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

Interventions

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

Sponsors & Collaborators

  • Amsterdam UMC

    collaborator OTHER

  • Hanneke W. M. van Laarhoven

    lead OTHER

Principal Investigators

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-25
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Netherlands

Study Locations

Related Clinical Trials

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06519292 on ClinicalTrials.gov