Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer

NCT06519292 | Recruiting DMC

• 1 other identifier: NL82446.018.22
• Study Type: observational
• Target: 214
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

immune checkpoint inhibitors; cardiovascular disease; atherosclerosis

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (3)

• Plaque characteristics (differences between baseline and follow-up)

  1 year

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

  3 months, 1 year

• Incidence of Arterial thromboembolic event

  1 year, 5 years

Other Outcomes (1)

• Venous thromboembolism

  1 year, 5 years

Study Arms (2)

ICI group

Patients that receive immune checkpoint inhibitors

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

Non-ICI group

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

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

Interventions

Coronary computed tomography angiography (CCTA) at baseline DIAGNOSTIC_TEST

Detailed imaging of coronary arteries

ICI group; Non-ICI group

Coronary computed tomography angiography (CCTA) after 1 year DIAGNOSTIC_TEST

Detailed imaging of coronary arteries

ICI group; Non-ICI group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult male or female subjects are eligible for study participation if they have a confirmed cancer diagnosis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanneke W. M. van Laarhoven: lead
• Amsterdam UMC: collaborator

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, serum and PBMC

MeSH Terms

Conditions

Cardiovascular Diseases; Myocardial Infarction; Stroke; Coronary Artery Disease; Atherosclerosis; Neoplasms

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• H.W.M. van Laarhoven, Prof. Dr.

  secretariaat.oncologie@amsterdamumc.nl

  PRINCIPAL INVESTIGATOR

Central Study Contacts

A Strijdhorst

CONTACT

+31 205665975; a.strijdhorst@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 25, 2024
• Study Start: January 25, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)