CardiotoxicityNCT05676606
Cardiotoxicity Monitoring With Single-lead Electrocardiogram
A study testing Remote 1-minute single-lead electrocardiogram (ECG) monitoring in cancer patients after the first polychemotherapy cycle. in people with Cardiotoxicity, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiotoxicity
- What is being tested?
- Remote 1-minute single-lead electrocardiogram (ECG) monitoring in cancer patients after the first polychemotherapy cycle.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 10 Dec 2020to 25 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow, 119991
About this study
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
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.
Read the 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.
- Conditions
- Cardiotoxicity
- Being tested
- Remote 1-minute single-lead electrocardiogram (ECG) monitoring in cancer patients after the first polychemotherapy cycle.
- Keywords
- 1-minute, single-lead ECG, cardiotoxicity, chemotherapy
- Medical subject headings
- Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote 1-minute single-lead electrocardiogram (ECG) monitoring in cancer patients after the first polychemotherapy cycle.Device
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.
| Study group | Role | What they receive |
|---|---|---|
| monitoring group | Experimental | a group of chemotherapy-naive patients with first time diagnosed various kinds of tumors, planned for the first cycle polychemotherapy treatment. Receives: Device: Remote 1-minute single-lead electrocardiogram (ECG) monitoring in cancer patients after the first polychemotherapy cycle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe asymptomatic cancer-therapy related cardiac dysfunction
Left ventricular ejection fraction reduction (LVEF) to < 40% .
Measured: Up to one month after the first cycle of chemotherapy treatment
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;
Measured: Up to one month after the first cycle of chemotherapy treatment
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.
Measured: Up to one month after the first cycle of chemotherapy treatment
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
Measured: Up to one month after the first cycle of chemotherapy treatment
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.
Measured: Up to one month after the first cycle of chemotherapy treatment
Chemotherapy-induced QTc interval prolongation:
QTc> 500 ms and\or QTc> 60 ms deviation from baseline.
Measured: Up to one month after the first cycle of chemotherapy treatment
Chemotherapy-induced arterial hypertension:
Steady increase in systolic arterial blood pressure ≥140 mmHg and/or diastolic ≥90 mmHg in period after chemotherapy.
Measured: Up to one month after the first cycle of chemotherapy treatment
Chemotherapy-induced arterial hypotension.
Steady decrease in systolic arterial blood pressure ≤ 100 mmHg and/or diastolic ≤ 90 mmHg.
Measured: Up to one month after the first cycle of chemotherapy treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start10 Dec 2020
- Primary completion25 May 2023
- Study completion25 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiotoxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philipp Kopylov, MD, Study director, I.M. Sechenov First Moscow State Medical University (Sechenov University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676606
- Sponsor's protocol ID
- FZ 01
- Status last verified
- Jan 2023
- First submitted
- 22 Dec 2022
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: local ethics committee prohibits disclosure patients' information Information can be provided upon official request addressed to the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05676606
- Acronym / sponsor ID
- FZ 01
- Conditions
- Cardiotoxicity
- Keywords
- 1-minute, single-lead ECG, cardiotoxicity, chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a group of chemotherapy-naive patients with first time diagnosed various kinds of tumors, planned for the first cycle polychemotherapy treatment.
| Arm | Type | Receives |
|---|---|---|
| monitoring group | Experimental | Device: Remote 1-minute single-lead electrocardiogram (ECG) monitoring in cancer patients after the first polychemotherapy cycle.a group of chemotherapy-naive patients with first time diagnosed various kinds of tumors, planned for the first cycle polychemotherapy treatment. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | monitoring group |
Primary outcome
Severe asymptomatic cancer-therapy related cardiac dysfunction
Time frame: Up to one month after the first cycle of chemotherapy treatment
Left ventricular ejection fraction reduction (LVEF) to < 40% .
Moderate asymptomatic cancer-therapy related cardiac dysfunction
Time frame: Up to one month after the first cycle of chemotherapy treatment
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
Time frame: Up to one month after the first cycle of chemotherapy treatment
LVEF ≥ 50% and new relative decline in GLS by >15% from baseline and/or new rise in cardiac biomarkers.
Chemotherapy-induced atrial fibrillation\ flutter.
Time frame: Up to one month after the first cycle of chemotherapy treatment
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
Time frame: Up to one month after the first cycle of chemotherapy treatment
* 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:
Time frame: Up to one month after the first cycle of chemotherapy treatment
QTc> 500 ms and\or QTc> 60 ms deviation from baseline.
Chemotherapy-induced arterial hypertension:
Time frame: Up to one month after the first cycle of chemotherapy treatment
Steady increase in systolic arterial blood pressure ≥140 mmHg and/or diastolic ≥90 mmHg in period after chemotherapy.
Chemotherapy-induced arterial hypotension.
Time frame: Up to one month after the first cycle of chemotherapy treatment.
Steady decrease in systolic arterial blood pressure ≤ 100 mmHg and/or diastolic ≤ 90 mmHg.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: No. local ethics committee prohibits disclosure patients' information Information can be provided upon official request addressed to the principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp Kopylov, MD study director
I.M. Sechenov First Moscow State Medical University (Sechenov University)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote 1-minute single-lead electrocardiogram (ECG) monitoring in cancer patients after the first polychemotherapy cycle. in people with Cardiotoxicity, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe asymptomatic cancer-therapy related cardiac dysfunction (time frame: Up to one month after the first cycle of chemotherapy treatment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.