Идёт набор NCT06519292

Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer

— Наблюдательное Cardiovascular Diseases Arterial Thrombosis Myocardial Infarction Stroke

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Coronary computed tomography angiography (CCTA) at baseline, Coronary computed tomography angiography (CCTA) after 1 year.
Кому может быть актуально: Состояния в реестре: Cardiovascular Diseases, Arterial Thrombosis, Myocardial Infarction, Stroke. Базовые параметры: от 50 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Нидерланды
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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).

Вмешательства

Диагностический тест Coronary computed tomography angiography (CCTA) at baseline
Detailed imaging of coronary arteries
Диагностический тест Coronary computed tomography angiography (CCTA) after 1 year
Detailed imaging of coronary arteries

Первичные конечные точки

Non-calcified coronary plaque volume (difference between baseline and follow-up CT) [Срок оценки: 1 year]

Вторичные конечные точки (3)

Plaque characteristics (differences between baseline and follow-up) [Срок оценки: 1 year]
Differences in plasma biomarkers (pro-inflammatory markers) between baseline and follow-up [Срок оценки: 3 months, 1 year]
Incidence of Arterial thromboembolic event [Срок оценки: 1 year, 5 years]

Критерии участия

Критерии включения

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