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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Severe asymptomatic cancer-therapy related cardiac dysfunction
研究概览
简要总结
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.
详细描述
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). 3. 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; 4. 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. 5. Instrumental examination: transthoracic echocardiography with assessment of left ventricular ejection fraction (LVEF) and speckle-tracking global longitudinal strain (GLS), standard 12-lead electrocardiography; 6. Laboratory testing: cardiac serum biomarkers-n-terminal pro b-type natriuretic peptide(NT-proBNP), highly sensitive troponin I.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
monitoring group
a group of chemotherapy-naive patients with first time diagnosed various kinds of tumors, planned for the first cycle polychemotherapy treatment.
干预措施: Remote 1-minute single-lead electrocardiogram (ECG) monitoring in cancer patients after the first polychemotherapy cycle. (Device)
结局指标
主要结局
Severe asymptomatic cancer-therapy related cardiac dysfunction
时间窗: Up to one month after the first cycle of chemotherapy treatment
Left ventricular ejection fraction reduction (LVEF) to \< 40% .
Chemotherapy-induced atrial fibrillation\ flutter.
时间窗: 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
时间窗: 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.
Moderate asymptomatic cancer-therapy related cardiac dysfunction
时间窗: 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
时间窗: 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 arterial hypertension:
时间窗: 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 QTc interval prolongation:
时间窗: 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 hypotension.
时间窗: 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.
次要结局
未报告次要终点