DIAGNOSTIC_TEST
ECHOCARDIOGRAPHY
A complete echocardiographic exam will be performed during each cardio-oncologic evaluation.
Status
Recruiting
Phase
Not applicable
Enrollment
300
Locations
1
Results
Not posted
Publications
0
Study 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.
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_TEST
A complete echocardiographic exam will be performed during each cardio-oncologic evaluation.
DIAGNOSTIC_TEST
An ECG tracing will be obtained during each cardio-oncologic evaluation.
DIAGNOSTIC_TEST
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.
Timeline
First posted
Oct 29, 2024
Study start
Feb 28, 2025
Primary completion
Nov 15, 2028
Study completion
Dec 15, 2028
Results posted
Not reported
Registry updated
Mar 4, 2025
Outcomes
Incidence of cardiotoxicity
Time frame · 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)
Time frame · 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.
Identification of early predictors of cardiotoxicity
Time frame · 24 months
Identification of any anamnestic, clinical, electrocardiographic and echocardiographic predictors of cardiotoxicity or major cardiovascular adverse events (MACE) at follow-up.
Eligibility
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.
Study locations
Italy. Showing up to 24 locations stored in the fast local snapshot.
Fondazione Policlinico Universitario A. Gemelli IRCCS;UOSD diagnostica cardiologica non invasiva
Rome, Lazio, Italy
Publications
No PMID-linked publications were present in this registry snapshot.
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