Cardiovascular Health and Prognosis in Adult Patients With Cancer Exposed to Cardiotoxic Therapies, an Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence of cardiotoxicity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Incidence of cardiotoxicity
时间窗: 24 months
Incidence of cancer therapy-related cardiovascular toxicity according to the definitions of the European Society of Cardiology Cardio-Oncology Guidelines, published in 2022.
Identification of major cardiovascular adverse events (MACE)
时间窗: 24 months
Identification of cardiovascular death, non-cardiovascular death and hospitalization for cardiac causes (congestive heart failure, major arrhythmias) both during the antineoplastic treatments and in the long-survivors population.
次要结局
- Identification of early predictors of cardiotoxicity(24 months)