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| Name | Class |
|---|---|
| Polish Cardiac Society | OTHER |
| Servier | INDUSTRY |
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Cardiological complications of oncological treatment, including the most serious of them cardiotoxicity and heart failure, constitute a significant and still unsolved clinical problem. A history of hypercholesterolaemia and coronary artery disease in cancer patients, is one of the risk factors for cardiotoxicity. In recent years, a protective effect of statin treatment on the development of heart failure in cancer patients has been observed. ANTEC (Atherosclerosis iN chemoTherapy-rElated Cardiotoxicity) is a prospective observational study aimed at assessing the impact of the advancement of atherosclerotic lesions in the coronary arteries assessed in computed tomography on the development of left ventricular systolic dysfunction in cancer patients at high risk of myocardial damage. A group of 80 patients diagnosed with cancer before starting high-dose anthracycline chemotherapy (doxorubicin ≥ 240 mg / m2 or epirubicin ≥ 600 mg / m2 body weight), without a history of heart failure and coronary artery disease, will be included in the study. The total follow-up of patients was planned for 12 months. The primary endpoint is time to onset of left ventricular systolic dysfunction as assessed by echocardiography. The secondary composite endpoints include all-cause death, cardiovascular death, myocardial infarction, and stroke. Additionally, the assessment will include: the severity of atherosclerotic changes in the coronary arteries and the calcification index in computed tomography, the percentage decrease in left ventricular ejection fraction, GLS (global longitudinal strain) in echocardiography, and changes in the concentration of biomarkers involved in inflammatory and atherosclerotic processes. This is the first study of this type, which we hope will contribute to a better understanding of the pathophysiology of cardiotoxicity development and to changing the standards of management of oncological patients and improving survival in this group of patients.
Cardiological complications of oncological treatment, including the most serious: cardiotoxicity and heart failure, remains the most dangerous cardiological complication of oncological treatment and are still unsolved clinical problem. The fear of the toxic effects of anti-cancer drugs may lead to the modification or abandonment of oncological treatment, and consequently shorten the survival time of cancer patients.
A history of hypercholesterolaemia and coronary artery disease in cancer patients, is one of the risk factors for cardiotoxicity. In recent years, a protective effect of statin treatment on the development of heart failure in cancer patients has been observed. ANTEC (Atherosclerosis iN chemoTherapy-rElated Cardiotoxicity) is a prospective observational study aimed at assessing the impact of the advancement of atherosclerotic lesions in the coronary arteries assessed in computed tomography on the development of left ventricular systolic dysfunction in cancer patients at high risk of myocardial damage. A group of 80 patients diagnosed with cancer before starting high-dose anthracycline chemotherapy (doxorubicin ≥ 240 mg / m2 or epirubicin ≥ 600 mg / m2 body weight), without a history of heart failure and coronary artery disease, will be included in the study. The total follow-up of patients was planned for 12 months. The primary endpoint is time to onset of left ventricular systolic dysfunction as assessed by echocardiography. The secondary composite endpoints include all-cause death, cardiovascular death, myocardial infarction, and stroke. Additionally, the assessment will include: the severity of atherosclerotic changes in the coronary arteries and the calcification index in computed tomography, the percentage decrease in left ventricular ejection fraction, GLS (global longitudinal strain) in echocardiography, and changes in the concentration of biomarkers involved in inflammatory and atherosclerotic processes. This is the first study of this type, which we hope will contribute to a better understanding of the pathophysiology of cardiotoxicity development and to changing the standards of management of oncological patients and improving survival in this group of patients.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| echocardiography, computed tomography | Diagnostic Test | echocardiography - including GLS and MWI computed tomography - with calcium score index |
| Measure | Description | Time Frame |
|---|---|---|
| Patients with left ventricular systolic dysfunction | echocardiography | from date of randomization until the end of study, up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the secondary composite endpoint: all-cause death, cardiovascular death, myocardial infarction, and stroke | medical records | from date of randomization until the end of study, up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The presence of atherosclerosis in the coronary arteries and the calcification index | computed tomography | from date of randomization until the end of study, up to 12 months |
| Percentage decrease in left ventricular ejection fraction, GLS (global longitudinal strain) and MWI (myocardial work index) |
Inclusion Criteria:
Exclusion Criteria:
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The study will include patients with diagnosed cancer, diagnosed and qualified for further systemic treatment at the National Institute of Oncology in Warsaw. Patients must give informed and voluntary consent to participate in the study and meet all the conditions for inclusion in the study
The size of the study group was calculated at 80 people. The estimated group size is based on the Cochran-Armitage test for the existence of a trend for a variable on an ordinal scale. The one-sided test was taken into account (alternative hypothesis - increase in the incidence of cardiotoxicity with the severity of atherosclerotic lesions versus null hypothesis - no effect). Assumptions: power - 80%, level of statistical significance - 0.05, one-tailed test for the presence of a trend.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Oncology | Warsaw | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37590267 | Derived | Borowiec A, Ozdowska P, Rosinska M, Jagiello-Gruszfeld A, Jasek S, Waniewska J, Kotowicz B, Kosela-Paterczyk H, Lampka E, Makowka A, Fuksiewicz M, Chojnacka M, Zebrowska A, Gepner K, Kapala A, Cieszanowski A, Nowecki Z, Walewski J. Prognostic value of coronary atherosclerosis and CAC score for the risk of chemotherapy-related cardiac dysfunction (CTRCD): The protocol of ANTEC study. PLoS One. 2023 Aug 17;18(8):e0288146. doi: 10.1371/journal.pone.0288146. eCollection 2023. |
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| ID | Term |
|---|---|
| D066126 | Cardiotoxicity |
| D050197 | Atherosclerosis |
| 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 |
| D014057 | Tomography, X-Ray Computed |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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blood samples
echocardiography |
| from date of randomization until the end of study, up to 12 months |
| Changes in the concentration of biomarkers involved in inflammatory and proatherosclerotic processes (IL-6, MPO i TNF-alfa). | blood samples | from date of randomization until the end of study, up to 12 months |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D007090 | Image Interpretation, Computer-Assisted |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014054 | Tomography |