Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiotoxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Remote 1-minute single-lead electrocardiogram (ECG) monitoring in cancer patients after the first polychemotherapy cycle. | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- monitoring group
- description
- a group of chemotherapy-naive patients with first time diagnosed various kinds of tumors, planned for the first cycle polychemotherapy treatment.
- interventionNames
- Device: Remote 1-minute single-lead electrocardiogram (ECG) monitoring in cancer patients after the first polychemotherapy cycle.
Primary outcomes (8)
- measure
- Severe asymptomatic cancer-therapy related cardiac dysfunction
- timeFrame
- Up to one month after the first cycle of chemotherapy treatment
- description
- Left ventricular ejection fraction reduction (LVEF) to \< 40% .
- measure
- Moderate asymptomatic cancer-therapy related cardiac dysfunction
- timeFrame
- Up to one month after the first cycle of chemotherapy treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available