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NCT05676606
Cardiotoxicity Monitoring With Single-lead Electrocardiogram
Conditions: Cardiotoxicity
Sex: All
Ages: 18 Years – 90 Years
Phase: NA
Enrollment: 128
Sponsor: I.M. Sechenov First Moscow State Medical University
Location: Russian Federation
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.
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 oldWritten informed consent to participate in the study.Patients without decompensation of cardiovascular diseasesNon-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 degreeCongenital or acquired heart valve diseasePatients with impaired motor function or tremor of the upper limb.
As well as patients with severe cognitive impairmentsPatients with a minimum life expectancy of less than 1 monthExclusion 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
Source: ClinicalTrials.gov (NCT05676606). StuddyBuddy aggregates publicly available trial information.