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NCT Number: NCT06519292

Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer

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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Key information

Conditions

Cardiovascular Diseases Arterial Occlusive Diseases Arterial Thrombosis Arteriosclerosis Atherosclerosis Brain Diseases Cancer Central Nervous System Diseases Cerebrovascular Disorders Coronary Artery Disease Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neoplasms Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam UMC

Amsterdam, North Holland, 1105AZ, Netherlands

Location status: Recruiting

Location contact

A Strijdhorst

CONTACT

[email protected]

+31 205665975

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary computed tomography angiography (CCTA) at baseline

Diagnostic Test

Detailed imaging of coronary arteries

Coronary computed tomography angiography (CCTA) after 1 year

Diagnostic Test

Detailed imaging of coronary arteries

Primary outcomes

  1. Non-calcified coronary plaque volume (difference between baseline and follow-up CT)

    Time frame: 1 year

Secondary outcomes

  1. Plaque characteristics (differences between baseline and follow-up)

    Time frame: 1 year

    Difference in plaque characteristics (i.e. fat attenuation index)

  2. Differences in plasma biomarkers (pro-inflammatory markers) between baseline and follow-up

    Time frame: 3 months, 1 year

    Immune cell composition, T cell composition, IL-1b, IL-6, NLRP3, IL-17, TNF-a, IFN-y

  3. Incidence of Arterial thromboembolic event

    Time frame: 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

Other outcomes

  1. Venous thromboembolism

    Time frame: 1 year, 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

A Strijdhorst

CONTACT

[email protected]

+31 205665975

Sponsors and collaborators

Lead sponsor

Hanneke W. M. van Laarhoven

Other

Collaborators

  • Amsterdam UMC

Registry information

Acronym: ITHACA

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2024
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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