Cardiovascular Health in Adult Patients With Cancer Exposed to Cardiotoxic Therapies

Официальное название

Cardiovascular Health and Prognosis in Adult Patients With Cancer Exposed to Cardiotoxic Therapies, an Observational Study

Обзор

The goal of this observational study is to evaluate the cardiovascular health and prognosis of adult patients with cancer, treated with cardiotoxic therapies. The main purposes of the study are the following: * Identify the demographic factors related to the onset of cardiotoxicity produced by anticancer drugs. * Identify any subgroups more likely to develop distant major adverse cardiovascular events (MACE). * Evaluate the usefulness of clinical, biohumoral and echocardiographic parameters for early diagnosis of cardiotoxicity. Participants will be monitored during the anticancer treatment via clinical, laboratory and instrumental evaluation according to the recommendation of the current guidelines on Cardio-Oncology (European Society of Cardiology, 2022). Initial follow-up will be 2 years.

Подробное описание

The goal of this observational study is to evaluate the cardiovascular health and prognosis of adult patients with cancer, exposed to potentially-cardiotoxic therapies.

The main purposes of the study are the following:

* Identify the demographic factors related to the onset of cardiotoxicity produced by anticancer drugs. * Identify any subgroups of patients more likely to develop distant major adverse cardiovascular events (MACE). * Evaluate the usefulness of clinical, bio-humoral and echocardiographic parameters for early diagnosis of cardiotoxicity.

Participants will be monitored during the anticancer treatment via clinical, laboratory and instrumental evaluation according to the recommendations of the available guidelines on Cardio-Oncology (European Society of Cardiology, 2022). Initial follow-up will be 2 years.

Вмешательства

• Диагностический тест ECHOCARDIOGRAPHY
  A complete echocardiographic exam will be performed during each cardio-oncologic evaluation.
• Диагностический тест ELECTROCARDIOGRAPHY (ECG)
  An ECG tracing will be obtained during each cardio-oncologic evaluation.
• Диагностический тест LABORATORY TESTS
  The cardiac biomarkers high-sensitivity troponin I and N-terminal pro-B-type natriuretic peptide (NT-proBNP) will be dosed according to the current recommendations of Cardio-Oncology Guidelines.

Первичные конечные точки

• Incidence of cardiotoxicity [Срок оценки: 24 months]
• Identification of major cardiovascular adverse events (MACE) [Срок оценки: 24 months]

Вторичные конечные точки (1)

• Identification of early predictors of cardiotoxicity [Срок оценки: 24 months]

Критерии участия

Критерии включения

• Patients over the age of 18 at the time of evaluation
• Patients treated with potentially cardiotoxic anticancer drugs
• Patients for which complete clinical, electrocardiographic and echocardiographic data are available at first evaluation and at least at one follow-up visit.

Критерии исключения

• Patients under the age of 18 at the time of evaluation
• Patients whose documentation of the first visit is not available
• Patients for whom it is not possible to obtain follow-up information through a medical visit or by telephone
• Patient with poor acoustic window for echocardiographic examination.
• Refusal of informed consent to participate in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• Fondazione Policlinico Universitario A. Gemelli IRCCS;UOSD diagnostica cardiologica non in — Rome

Идентификаторы

NCT: NCT06664528 · 6977

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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