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Cardiotoxicity Monitoring With Single-lead Electrocardiogram

Primary Purpose

Cardiotoxicity

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Remote 1-minute single-lead electrocardiogram (ECG) monitoring in cancer patients after the first polychemotherapy cycle.
Sponsored by
I.M. Sechenov First Moscow State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiotoxicity focused on measuring 1-minute, single-lead ECG, cardiotoxicity, chemotherapy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: chemotherapy-naive patients with first time diagnosed various kinds of tumors, planned for the first cycle polychemotherapy treatment over 18 years old Written informed consent to participate in the study. Patients without decompensation of cardiovascular diseases Non-inclusion criteria: Pregnancy; Severe hepatic and\or renal failure(glomerular filtration rate below 30 (ml\min\1.732) Cockcroft-Gault, Child-Pugh score less than 6 points; Radiation therapy and\or any surgical treatment in last 30 days. Heart failure with left ventricular ejection fraction< 50 %, III-IV functional class New York Heart Association Functional Classification (NYHA) Cardiac arrhythmias - permanent form of atrial fibrillation\flutter, atrioventricular block (AV block) II-III degree Congenital or acquired heart valve disease Patients with impaired motor function or tremor of the upper limb. As well as patients with severe cognitive impairments Patients with a minimum life expectancy of less than 1 month Exclusion Criteria: Refusal to further participate in the study; Non-compliance to the therapy regimen. Poor quality ECG, poor echocardiography visualization,detection a defect of the preanalytical stage of the blood biochemical analysis (hemolysis, non-compliance with the temperature regime, long-term transportation, long-term storage, long-term or repeated centrifugation). Development of other toxicity during chemotherapy treatment, which might prevents the evaluation of the study results

Sites / Locations

  • I.M. Sechenov First Moscow State Medical University (Sechenov University)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

monitoring group

Arm Description

a group of chemotherapy-naive patients with first time diagnosed various kinds of tumors, planned for the first cycle polychemotherapy treatment.

Outcomes

Primary Outcome Measures

Severe asymptomatic cancer-therapy related cardiac dysfunction
Left ventricular ejection fraction reduction (LVEF) to < 40% .
Moderate asymptomatic cancer-therapy related cardiac dysfunction
LVEF reduction by ≥10 percentage points to an LVEF of 40-49% or new LVEF reduction by < 10 percentage points to an LVEF of 40-49% and either new relative decline in GLS by >15% from baseline or new rise in cardiac biomarkers;
Mild asymptomatic cancer-therapy related cardiac dysfunction
LVEF ≥ 50% and new relative decline in GLS by >15% from baseline and/or new rise in cardiac biomarkers.
Chemotherapy-induced atrial fibrillation\ flutter.
Rhythm with no discernible repeating P waves and irregular RR intervals is diagnosed on an standard 12-lead ECG or a single-lead ECG tracing of ≥ 30 s recording
Chemotherapy- induced atrioventricular block I-III degrees
First-degree atrioventricular block, on ECG, this is defined by a PR interval greater than 200 mc Second-degree atrioventricular block; not all P-waves are followed byQRS complexes. Second-degree atrioventricular blockMobitz type I- this manifest on the ECG as gradual increase of PR interval before a block of QRS complexes occurs. Second-degree atrioventricular blockMobitz type II-the block of QRS complexes occurs without gradual increase of PR interval. • Third degree atrioventricular block- on the ECG P-waves have no relation to the QRS complexes.
Chemotherapy-induced QTc interval prolongation:
QTc> 500 ms and\or QTc> 60 ms deviation from baseline.
Chemotherapy-induced arterial hypertension:
Steady increase in systolic arterial blood pressure ≥140 mmHg and/or diastolic ≥90 mmHg in period after chemotherapy.
Chemotherapy-induced arterial hypotension.
Steady decrease in systolic arterial blood pressure ≤ 100 mmHg and/or diastolic ≤ 90 mmHg.

Secondary Outcome Measures

Full Information

First Posted
December 22, 2022
Last Updated
September 27, 2023
Sponsor
I.M. Sechenov First Moscow State Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05676606
Brief Title
Cardiotoxicity Monitoring With Single-lead Electrocardiogram
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2020 (Actual)
Primary Completion Date
May 25, 2024 (Anticipated)
Study Completion Date
May 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
I.M. Sechenov First Moscow State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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): Signing a voluntary informed consent to participate in the study; 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). 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; 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. Instrumental examination: transthoracic echocardiography with assessment of left ventricular ejection fraction (LVEF) and speckle-tracking global longitudinal strain (GLS), standard 12-lead electrocardiography; 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): Patients' clinical examination, complaints registration; Instrumental examination: transthoracic echocardiography with assessment of left ventricular ejection fraction (LVEF) and speckle-tracking global longitudinal strain (GLS), standard 12-lead electrocardiography; Laboratory testing:cardiac serum biomarkers -n-terminal pro b-type natriuretic peptide (NT-proBNP), highly sensitive troponin I); 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; Database compilation and statistical processing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiotoxicity
Keywords
1-minute, single-lead ECG, cardiotoxicity, chemotherapy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
a group of chemotherapy-naive patients with first time diagnosed various kinds of tumors, planned for the first cycle polychemotherapy treatment.
Masking
None (Open Label)
Allocation
N/A
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
monitoring group
Arm Type
Experimental
Arm Description
a group of chemotherapy-naive patients with first time diagnosed various kinds of tumors, planned for the first cycle polychemotherapy treatment.
Intervention Type
Device
Intervention Name(s)
Remote 1-minute single-lead electrocardiogram (ECG) monitoring in cancer patients after the first polychemotherapy cycle.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Severe asymptomatic cancer-therapy related cardiac dysfunction
Description
Left ventricular ejection fraction reduction (LVEF) to < 40% .
Time Frame
Up to one month after the first cycle of chemotherapy treatment
Title
Moderate asymptomatic cancer-therapy related cardiac dysfunction
Description
LVEF reduction by ≥10 percentage points to an LVEF of 40-49% or new LVEF reduction by < 10 percentage points to an LVEF of 40-49% and either new relative decline in GLS by >15% from baseline or new rise in cardiac biomarkers;
Time Frame
Up to one month after the first cycle of chemotherapy treatment
Title
Mild asymptomatic cancer-therapy related cardiac dysfunction
Description
LVEF ≥ 50% and new relative decline in GLS by >15% from baseline and/or new rise in cardiac biomarkers.
Time Frame
Up to one month after the first cycle of chemotherapy treatment
Title
Chemotherapy-induced atrial fibrillation\ flutter.
Description
Rhythm with no discernible repeating P waves and irregular RR intervals is diagnosed on an standard 12-lead ECG or a single-lead ECG tracing of ≥ 30 s recording
Time Frame
Up to one month after the first cycle of chemotherapy treatment
Title
Chemotherapy- induced atrioventricular block I-III degrees
Description
First-degree atrioventricular block, on ECG, this is defined by a PR interval greater than 200 mc Second-degree atrioventricular block; not all P-waves are followed byQRS complexes. Second-degree atrioventricular blockMobitz type I- this manifest on the ECG as gradual increase of PR interval before a block of QRS complexes occurs. Second-degree atrioventricular blockMobitz type II-the block of QRS complexes occurs without gradual increase of PR interval. • Third degree atrioventricular block- on the ECG P-waves have no relation to the QRS complexes.
Time Frame
Up to one month after the first cycle of chemotherapy treatment
Title
Chemotherapy-induced QTc interval prolongation:
Description
QTc> 500 ms and\or QTc> 60 ms deviation from baseline.
Time Frame
Up to one month after the first cycle of chemotherapy treatment
Title
Chemotherapy-induced arterial hypertension:
Description
Steady increase in systolic arterial blood pressure ≥140 mmHg and/or diastolic ≥90 mmHg in period after chemotherapy.
Time Frame
Up to one month after the first cycle of chemotherapy treatment
Title
Chemotherapy-induced arterial hypotension.
Description
Steady decrease in systolic arterial blood pressure ≤ 100 mmHg and/or diastolic ≤ 90 mmHg.
Time Frame
Up to one month after the first cycle of chemotherapy treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: chemotherapy-naive patients with first time diagnosed various kinds of tumors, planned for the first cycle polychemotherapy treatment over 18 years old Written informed consent to participate in the study. Patients without decompensation of cardiovascular diseases Non-inclusion criteria: Pregnancy; Severe hepatic and\or renal failure(glomerular filtration rate below 30 (ml\min\1.732) Cockcroft-Gault, Child-Pugh score less than 6 points; Radiation therapy and\or any surgical treatment in last 30 days. Heart failure with left ventricular ejection fraction< 50 %, III-IV functional class New York Heart Association Functional Classification (NYHA) Cardiac arrhythmias - permanent form of atrial fibrillation\flutter, atrioventricular block (AV block) II-III degree Congenital or acquired heart valve disease Patients with impaired motor function or tremor of the upper limb. As well as patients with severe cognitive impairments Patients with a minimum life expectancy of less than 1 month Exclusion Criteria: Refusal to further participate in the study; Non-compliance to the therapy regimen. Poor quality ECG, poor echocardiography visualization,detection a defect of the preanalytical stage of the blood biochemical analysis (hemolysis, non-compliance with the temperature regime, long-term transportation, long-term storage, long-term or repeated centrifugation). Development of other toxicity during chemotherapy treatment, which might prevents the evaluation of the study results
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kopylov
Phone
+7 (903) 687 72 64
Email
kopylov_f_yu@staff.sechenov.ru
First Name & Middle Initial & Last Name or Official Title & Degree
ZAKI FASHAFSHA
Phone
+79018033138
Email
fashafsha_z_z@staff.sechenov.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philipp Kopylov, MD
Organizational Affiliation
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Official's Role
Study Director
Facility Information:
Facility Name
I.M. Sechenov First Moscow State Medical University (Sechenov University)
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philipp Kopylov
Phone
+79036877264
Email
kopylov_f_yu@staff.sechenov.ru
First Name & Middle Initial & Last Name & Degree
ZAKI FASHAFSHA
Phone
+79018033138
Email
fashafsha_z_z@staff.sechenov.ru

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
local ethics committee prohibits disclosure patients' information Information can be provided upon official request addressed to the principal investigator

Learn more about this trial

Cardiotoxicity Monitoring With Single-lead Electrocardiogram

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