Extensive CArdioVAscular Characterization and Follow-up of Patients Receiving Immune Checkpoint Inhibitors

Summary

The goal of this prospective, multicentre study is to investigate short- and long-term cardiovascular effects in cancer patients treated with immune checkpoint inhibitors (ICIs).

The main question\[s\] it aims to answer are:

* To investigate troponin and NT-proBNP values in patients receiving ICIs and their association with ICI-induced CV abnormalities and MACEs.
* Study the calcium score, systolic, and diastolic (dys)function.
* Evaluate associations between patient/disease characteristics / transthoracic echocardiography parameters / electrocardiography parameters and troponin / NT-proBNP levels.

Participants will be closely monitored by performing the following additional visits and testing:

* Chest CT scan prior to treatment start, after 12 and 24 months.
* Consultation with a cardiologist at baseline, 3, 6, 12 and 24 months, who will perform an electrocardiogram and echocardiogram.
* One additional blood sample prior to treatment start, after 3, 6, 12 and 24 months. An extra blood sample could be taken in case of sudden heart problems.
* Non-invasive endothelial function tests prior to treatment start, after 12 and 24 months.

Conditions

• Cancer
• Immune-related Adverse Event
• Cardiac Abnormalities, Variable
• Immune Checkpoint Inhibitor-Related Myocarditis
• Diastolic Dysfunction
• Atherosclerosis
• Cardiotoxicity

Interventions

PROCEDURE

Cardiology consultation

* Electrocardiogram (ECG). * Echocardiogram: A comprehensive evaluation of systolic and diastolic function, ventricular and atrial geometry will be performed. Special attention will be given to acquire a 3D measurement of left ventricular ejection fraction (LVEF) and to perform deformation imaging of left ventricle (global longitudinal strain (GLS)). The right ventricular function will be evaluated by tricuspid annular plane systolic excursion (TAPSE) and peak systolic velocity S' derived from color coded tissue Doppler imaging (TDI). Diastolic dysfunction will be based on average E/e' ratio \> 15 and left atrial (LA) area \> 30 cm2.

DIAGNOSTIC_TEST

Chest Computed Tomography (CT) without contrast

Calcium score. This will be performed at baseline, 12 and 24 months. The scans at 12 and 24 months will be combined, if possible, with standard of care scans for cancer treatment.

PROCEDURE

Non-invasive endothelial function tests

* FMD * PAT This aspect of the study will only be performed in the patients included by the Antwerp University Hospital due to organizational/practical issues.

PROCEDURE

Electrocardiogram

An ECG will be taken prior to each ICI cycle during the first three months of treatment.

DIAGNOSTIC_TEST

Extra serum sample (7.5 mL)

An extra serum sample will be taken at baseline, 3, 6, 12, 24 months and in case of sudden cardiac problems. This will subsequently be analysed to determine high-sensitivity troponin I, high-sensitivity troponin T and NT-proBNP.

Sponsors & Collaborators

• Algemeen Ziekenhuis Maria Middelares

  lead OTHER

Principal Investigators

• Christof Vulsteke, Prof · Algemeen Ziekenhuis Maria Middelares

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-07

Primary Completion

2024-07-12

Completion

2024-07-12

Countries

• Belgium

Study Locations