NCT05676606

Cardiotoxicity Monitoring With Single-lead Electrocardiogram

Official Title: Remote 1-minute Single-lead Electrocardiogram (ECG) Monitoring for Cardiotoxicity Detection in Patients With the First Diagnosed Cancer After the First Cycle of Polychemotherapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: I.M. Sechenov First Moscow State Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This research is a multi-center prospective cohort interventional study aimed to determinate the capabilities of remote 1-minute single-lead electrocardiogram monitoring for cardiotoxicity detection, during two- three weeks (depending on the scheme of polychemotherapy) after the first cycle of polychemotherapy in patients with the first diagnosed cancer.

Detailed description

The study planned to include 130 patients and will be conducted in three stages: Stage one - screening (the day before chemotherapy treatment): 1. Signing a voluntary informed consent to participate in the study; 2. Clinical examination; Questioning: finding out the complaints. Anamnesis morbid: investigation of the history of cardiovascular diseases (the presence of hypertension, ischemic heart disease, diabetes mellitus, congenital heart disease, heart surgery in the past). Anamnesis vitae: investigation of the history of patient's life (place of birth, development in childhood and adolescence, tobacco smoking, consumption of alcohol beverage, narcotic drugs, sleeping pills and sedatives, strong tea and coffee). 3. Assessment patient's risk profile according to the cardiotoxicity risk assessment scale for treatment of tumors (C.M. Larsen assessment scale 2014). Risk level-the sum of points of all risks ((1) the risk associated with the specific chemotherapy that will be received and (2) the risk related to co-existing cardiac risk factors, age and sex of patients), these factors can be used to generate a risk score: \>6 points-very high risk, 5-6 points - high risk; 3-4 points- intermediate risk; 1-2 points-rare risk; 4. All patients included in the study will be registered in single-lead ECG server base and will be trained to use single-lead electrocardiograph themselves. Before starting chemotherapy, each patient will record an 1-minute single-lead ECG. 5. Instrumental examination: transthoracic echocardiography with assessment of left ventricular ejection fraction (LVEF) and speckle-tracking global longitudinal strain (GLS), standard 12-lead electrocardiography; 6. Laboratory testing: cardiac serum biomarkers-n-terminal pro b-type natriuretic peptide(NT-proBNP), highly sensitive troponin I. Stage two - interim home control (during 2-3 weeks after first cycle of the chemotherapy): During this period, patients will registrate a single-lead electrocardiogram by themselves using single-lead ECG device, every day the patient should do at least 5 ECG records. The data will be sent to the server database, where cardiologist will check it for pathology, poor quality and will contact patients, if needed. Stage three - final control (after first course of the chemotherapy): 1. Patients' clinical examination, complaints registration; 2. Instrumental examination: transthoracic echocardiography with assessment of left ventricular ejection fraction (LVEF) and speckle-tracking global longitudinal strain (GLS), standard 12-lead electrocardiography; 3. Laboratory testing:cardiac serum biomarkers -n-terminal pro b-type natriuretic peptide (NT-proBNP), highly sensitive troponin I); 4. Evaluation of outcomes,depending on the patient's complaints, the results of instrumental and biochemical test methods carried out. The patient will be given recommendations necessary for their cardiovascular disorders correction; 5. Database compilation and statistical processing.

Conditions

• Cardiotoxicity

Interventions

Type	Name	Description
DEVICE	Remote 1-minute single-lead electrocardiogram (ECG) monitoring in cancer patients after the first polychemotherapy cycle.	Recording of the ECG using smart-phone at rest, 15 minutes before registering ECG patient should not smoke,having tea, coffee, alcohol. During the ECG recording hands should be fixed to avoid poor quality. Patient sitting on a char with tow hands fixed on a table holding electrocardiograph with index fingers placed at the ECG electrode (left) and at the photoplethysmograph sensor(right).ECG signals are recorded from the fingers using first standard ECG lead. After registration, all ECG and photoplethysmography data will be sent to the server. The data will be automatically compared with a standard for data quality, after that the data will be sent to cardiologist. If quality will be not sufficient, the data will be deleted and the doctor will contact the patient to solve the quality issue. Thereafter, the parameters will be carried out by cardiologist, on the basis of which value of ECG monitoring will be estimated.

Timeline

• Start date: 2020-12-10
• Primary completion: 2023-05-25
• Completion: 2023-05-25
• First posted: 2023-01-09
• Last updated: 2024-03-08

Locations

1 site across 1 country: Russia