Cardiotoxicity Monitoring With Single-lead Electrocardiogram

NCT05676606 | Completed

• 1 other identifier: FZ 01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiotoxicity

Keywords

1-minute; single-lead ECG; cardiotoxicity; chemotherapy

Outcome Measures

Primary Outcomes (8)

• Severe asymptomatic cancer-therapy related cardiac dysfunction

  Left ventricular ejection fraction reduction (LVEF) to \< 40% .

  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;

  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.

  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

  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.

  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.

  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.

  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.

  Up to one month after the first cycle of chemotherapy treatment.

Study Arms (1)

monitoring group

EXPERIMENTAL

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

Device: Remote 1-minute single-lead electrocardiogram (ECG) monitoring in cancer patients after the first polychemotherapy cycle.

Interventions

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.

monitoring group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

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

Moscow, 119991, Russia

Location

MeSH Terms

Conditions

Cardiotoxicity

Interventions

Electrocardiography

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

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Philipp Kopylov, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 9, 2023
• Study Start: December 10, 2020
• Primary Completion: May 25, 2023
• Study Completion: May 25, 2023
• Last Updated: March 8, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)