Clinical trial NCT06519292: Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer
Official title: Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Arterial Thrombosis
Myocardial Infarction
Stroke
Coronary Artery Disease
Atherosclerosis
Cancer
Keywords: immune checkpoint inhibitors
cardiovascular disease
atherosclerosis
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Amsterdam UMC
First posted: 2024-07-25
Enrollment: 214
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult male or female subjects are eligible for study participation if they have a confirmed cancer diagnosis

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).


Eligibility criteria: 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

Primary outcomes:
measure: Non-calcified coronary plaque volume (difference between baseline and follow-up CT)
timeFrame: 1 year
Secondary outcomes:
measure: Plaque characteristics (differences between baseline and follow-up)
timeFrame: 1 year
measure: Differences in plasma biomarkers (pro-inflammatory markers) between baseline and follow-up
timeFrame: 3 months, 1 year
measure: Incidence of Arterial thromboembolic event
timeFrame: 1 year, 5 years
Other outcomes:
measure: Venous thromboembolism
timeFrame: 1 year, 5 years
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
Study officials:
affiliation: secretariaat.oncologie@amsterdamumc.nl
name: H.W.M. van Laarhoven, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: