Cardiotoxicity Clinical Trial
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
NCT number | NCT05676606 |
Other study ID # | FZ 01 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 10, 2020 |
Est. completion date | May 25, 2023 |
Verified date | January 2023 |
Source | I.M. Sechenov First Moscow State Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | May 25, 2023 |
Est. primary completion date | May 25, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 1. 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 2. 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 3. 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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | I.M. Sechenov First Moscow State Medical University (Sechenov University) | Moscow |
Lead Sponsor | Collaborator |
---|---|
I.M. Sechenov First Moscow State Medical University |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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. |
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