Cardiovascular Health in Adult Patients With Cancer Exposed to Cardiotoxic Therapies
NCT ID: NCT06664528
Last Updated: 2025-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2025-02-28
2028-12-15
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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ECHOCARDIOGRAPHY
A complete echocardiographic exam will be performed during each cardio-oncologic evaluation.
ELECTROCARDIOGRAPHY (ECG)
An ECG tracing will be obtained during each cardio-oncologic evaluation.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Principal Investigators
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Antonella Lombardo
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Locations
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Fondazione Policlinico Universitario A. Gemelli IRCCS;UOSD diagnostica cardiologica non invasiva
Rome, Lazio, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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6977
Identifier Type: -
Identifier Source: org_study_id
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