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

Algemeen Ziekenhuis Maria Middelares · 2022
ClinicalTrials.gov · Datasets · License: Public Domain · 2022
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atherosclerosiscancercardiotoxicitydiastolic-dysfunctionimmune-checkpoint-inhibitorimmune-related-adverse-eventmyocarditis
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.
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