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NCT Number: NCT05118178

Atherosclerosis in Chemotherapy-related Cardiotoxicity

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.
  • Age ≥18 years at the time of signing the informed consent.
  • Known neoplastic disease prior to the initiation of chemotherapy with a high dose of anthracyclines (doxorubicin ≥ 240 mg / m2 b.w. or epirubicin ≥ 600 mg / m2 b.w.)
  • No history of heart failure (left ventricular ejection fraction ≥ 50% as assessed by echocardiography).
  • No history of: coronary artery disease, stroke and lower limb atherosclerosis
  • At least moderate baseline cardiovascular toxicity risk according to Heart Failure Association-International Cardio-Oncology Society stratification

Exclusion criteria

  • History of heart failure
  • Left ventricle systolic dysfunction with LVEF <50%
  • Significant valve defect
  • Previous chemotherapy or radiation to the chest
  • Presence of any disease with a life expectancy <1 year in the opinion of the investigator.
  • Drug or alcohol abuse
  • Lack of possibility or contraindications for coronary tomography before starting chemotherapy

Treatment and study plan

echocardiography, computed tomography

Diagnostic Test

echocardiography - including GLS and MWI computed tomography - with calcium score index

Primary outcomes

  1. Patients with left ventricular systolic dysfunction

    Time frame: from date of randomization until the end of study, up to 12 months

    echocardiography

Secondary outcomes

  1. Time to the secondary composite endpoint: all-cause death, cardiovascular death, myocardial infarction, and stroke

    Time frame: from date of randomization until the end of study, up to 12 months

    medical records

Other outcomes

  1. The presence of atherosclerosis in the coronary arteries and the calcification index

    Time frame: from date of randomization until the end of study, up to 12 months

    computed tomography

  2. Percentage decrease in left ventricular ejection fraction, GLS (global longitudinal strain) and MWI (myocardial work index)

    Time frame: from date of randomization until the end of study, up to 12 months

    echocardiography

  3. Changes in the concentration of biomarkers involved in inflammatory and proatherosclerotic processes (IL-6, MPO i TNF-alfa).

    Time frame: from date of randomization until the end of study, up to 12 months

    blood samples

Sponsors and collaborators

Lead sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Other

Collaborators

  • Polish Cardiac Society
  • Servier

Registry information

Official study title

Prognostic Significance of the Atherosclerosis in the Coronary Arteries Assessed in Computed Tomography on the Cardiotoxicity Development After Oncological Treatment

Acronym: ANTEC

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Nov 11, 2021
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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