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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:
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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECHOCARDIOGRAPHY | Diagnostic Test | A complete echocardiographic exam will be performed during each cardio-oncologic evaluation. | ||
| ELECTROCARDIOGRAPHY (ECG) | Diagnostic Test | An ECG tracing will be obtained during each cardio-oncologic evaluation. | ||
| LABORATORY TESTS | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of cardiotoxicity | Incidence of cancer therapy-related cardiovascular toxicity according to the definitions of the European Society of Cardiology Cardio-Oncology Guidelines, published in 2022. | 24 months |
| Identification of major cardiovascular adverse events (MACE) | 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of early predictors of cardiotoxicity | Identification of any anamnestic, clinical, electrocardiographic and echocardiographic predictors of cardiotoxicity or major cardiovascular adverse events (MACE) at follow-up. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with cancer treated with potentially cardiotoxic anticancer drugs, with complete clinical, laboratory, electrocardiographic and echocardiographic data obtained at the first cardio-oncologic evaluation and at least at one follow-up visit.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonella Lombardo | Contact | +390630157070 | antonella.lombardo@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Antonella Lombardo | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS;UOSD diagnostica cardiologica non invasiva | Recruiting | Rome | Lazio | 00168 | Italy |
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| ID | Term |
|---|---|
| D066126 | Cardiotoxicity |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| D004562 | Electrocardiography |
| D019411 | Clinical Laboratory Techniques |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D004568 | Electrodiagnosis |
| D008919 | Investigative Techniques |