Cardiac Toxicity, Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTELECTROCARDIOGRAPHY (ECG)
An ECG tracing will be obtained during each cardio-oncologic evaluation.
DIAGNOSTIC_TESTLABORATORY 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.
DIAGNOSTIC_TESTECHOCARDIOGRAPHY
A complete echocardiographic exam will be performed during each cardio-oncologic evaluation.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of cardiotoxicity | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identification of early predictors of cardiotoxicity | 24 months | Identification of any anamnestic, clinical, electrocardiographic and echocardiographic predictors of cardiotoxicity or major cardiovascular adverse events (MACE) at follow-up. |
Countries
Italy
Contacts
Primary ContactAntonella Lombardo
Outcome results
None listed