Early diagnosis and prevention of chemotherapy cardiotoxic effects in breast cancer patients Circulatory System
Conditions
Interventions
1. A retrospective analysis of medical records (of patients with breast cancer who were administered chemotherapy in the University's clinic during 2018-2019, inpatient and outpatient divisions).
2. A
cerebral natriuretic peptide (BNP)
myeloperoxidase (MPO), galectin-3 (gal-3), D-dimer.
Holter monitoring: 24-record 12-channel ECG using wearable devices
Transthoracic echocardiography and speckle tracking.
Data collection: every three months, 5 (five) patient visits.
The prospective samples will be divided into four groups of cardiotoxic risk at base
Sponsors
Ministry of Education and Science of the Republic of Kazakhstan
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Verified diagnosis of C50 malignant neoplasm of the breast at any stage (if eligible for chemotherapy), according to the Republican Protocol for Diagnosis and Treatment of Breast Cancer dated March 01, 2019, No. 56, upon admittance to the University's Medical Center 2. Any age 3. Out/inpatient treatment in the Medical Center 4. Targeted therapy upon the confirmed positive Her2 status and/or Anthracyclines administering 5. Simpson left ventricular ejection fraction =40% without symptoms of heart failure established within 30 days before admission to the chemotherapy division
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 29/07/2022: 1. Coronary heart disease (CHD) progression or congestive heart failure (CHF) decompensation 2. Simpson left ventricular ejection fraction =40% 3. Any recurrent comorbid pathology decompensation _____ Previous participant exclusion criteria: 1. Presence of recorded cardiotoxic effects of chemotherapy, regardless of the limitation period 2. Coronary heart disease (CHD) progression or congestive heart failure (CHF) decompensation in the previous six months 3. Simpson left ventricular ejection fraction =40%; 4. Decompensation of comorbid pathology within the previous three months: 4.1. Endocrine diseases 4.2. Diseases of the liver 4.3. Diseases of the kidneys 4.4. Diseases of the bronchopulmonary system
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 29/07/2022: 1. Number of patients who developed cardiotoxic complications, including subclinical dysfunction during chemotherapy measured using left ventricular ejection fraction (LVEF) monitoring (10% decline from baseline) and global longitudinal strain (GLS) assessment (decrease >15% from baseline) at 12 months after the chemotherapy course started, through all groups at risk 2. One-year survival without cardiotoxic complications measured using LVEF monitoring and GLS assessment (as defined above) at 12 months after chemotherapy completion through all groups at risk _____ Previous primary outcome measure: 1. Number of patients who developed cardiotoxic complications during chemotherapy measured using left ventricular ejection fraction (LVEF) monitoring (10% decline from baseline) and global longitudinal strain (GLS) assessment (decrease >15% from baseline) at 12 months after the chemotherapy course started 2. One-year survival without cardiotoxic complications measured using LVEF monitoring and GLS assessment (as defined above) at 12 months after chemotherapy completion | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure as of 29/07/2022: Measured using biomarker measurement units on immunoassay analyzers at 3, 6, 9, and 12 months for all below: 1. Presence of increased values of the tests during chemotherapy treatment: 1.1. Cardiac troponin (cTnI) - =0.3 ng/ml 1.2. Brain natriuretic peptide (BNP) - >100 pg/ml 1.3. C-reactive protein (CRP) - >5 mg/l 1.4. Antibodies to Myeloperoxidase (MPO) - >5 U/ml 1.5. Galectin-3 (gal-3) - >28.7 ng/ml 1.6. D-dimer - =0.5 mg/l. 2. Time trends in the biomarkers values elevation' onset applied to LVEF and GLS data. 3. The predictive value of a positive result (PPV) and the predictive value of a negative result (PVN) for all listed biomarkers 4. Frequency of all identified cardiovascular events during observation _____ Previous secondary outcome measure: Measured using Finecare analyzer immunofluorescence platform biomarker measurement units at 3, 6, 9, and 12 months for all below: 1. Presence of increased values of the tests during chemotherapy treatment: 1.1. Cardiac troponin (cTnI) - =0.3 ng/ml 1.2. Brain natriuretic peptide (BNP) - >100 pg/ml 1.3. C-reactive protein (CRP) - >5 mg/l 1.4. Antibodies to Myeloperoxidase (MPO) - >5 U/ml 1.5. Galectin-3 (gal-3) - >28.7 ng/ml 1.6. D-dimer - =0.5 mg/l. 2. The predictive value of a positive result (PPV) and the predictive value of a negative result (PVN) for: 2.1. Cardiac troponin (cTnI) 2.2. Brain natriuretic peptide (BNP) 2.3. C-reactive protein (CRP) 2.4. Myeloperoxidase (MPO) 2.5. Galectin-3 (gal-3) 2.6. D-dimer | — |
Countries
Kazakhstan
Outcome results
None listed