Atherosclerosis in Chemotherapy-related Cardiotoxicity

NCT05118178 | Completed DMC

• 1 other identifier: 80/2021
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiotoxicity; Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Patients with left ventricular systolic dysfunction

  echocardiography

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

Secondary Outcomes (1)

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

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

Other Outcomes (3)

• The presence of atherosclerosis in the coronary arteries and the calcification index

  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)

  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).

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

Interventions

echocardiography, computed tomography DIAGNOSTIC_TEST

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead
• Polish Cardiac Society: collaborator
• Servier: collaborator

Study Sites (1)

National Institute of Oncology

Warsaw, Poland

Location

Related Publications (1)

• 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.

  PMID: 37590267 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Cardiotoxicity; Atherosclerosis

Interventions

Echocardiography; Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Image Interpretation, Computer-Assisted; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 11, 2021
• Study Start: November 15, 2021
• Primary Completion: September 15, 2024
• Study Completion: March 15, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)