Role of Myocardial Work in the Prediction of Cardiac Dysfunction and Response After Revalidation in Patients With Cancer Undergoing Chemotherapy and/or Radiotherapy
试验速览
- 阶段
- 不适用
- 入组人数
- 191
- 试验地点
- 1
- 主要终点
- Change in the minute ventilation/carbon dioxide production (VE/VCO2) slope
研究概览
简要总结
This study regarding oncological patients for rehabilitation after specific cancer therapy involves three aims: (1) to evaluate the predictive value of myocardial work parameters on the improvement of exercise performance after rehabilitation, (2) to determine which echocardiographic parameters are more suitable in predicting cardiac dysfunction, and (3) to evaluate the correlation between echocardiographic parameters and fibrosis detected by cardiac magnetic resonance imaging (CMR).
详细描述
Myocardial work (MW) provides an estimation of cardiac function by combining global longitudinal strain (GLS) with blood pressure values obtained non-invasively, being less load dependent than standard GLS. The investigator hypothesize that myocardial work could be a useful marker for predicting the exercise performance after chemotherapy and/or radiotherapy in oncological patients undergoing rehabilitation. Moreover, this study may provide additional information in optimal selection for rehabilitation programs.
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
- •Patients diagnosed with cancer
- •Undergoing chemotherapy and/or radiotherapy/hormone therapy
- •Age older than 18 years old - maximum age of 90 years old
- •Willing to enter revalidation in Universitair Ziekenhuis Brussel
- •Signed consent form
排除标准
- •Severe aortic stenosis defined as aortic valve aria under 0.6 cm2/m2
- •Supraventricular arrhythmias
- •Poor image quality for 2D and 3D echocardiography defined as the impossibility to examine of more than 2 adjacent segments
- •Resistant hypertension defined as uncontrolled blood pressure values under current European guidelines, Systolic Blood Pressure more than 140 mmHg and/or Diastolic Blood Pressure more than 80 mmHg
- •Lung cancer
研究组 & 干预措施
Oncology patients
Patients diagnosed with cancer and treated with chemotherapy and/or radiotherapy
干预措施: Cardiorespiratory exercise test (Diagnostic Test)
结局指标
主要结局
Change in the minute ventilation/carbon dioxide production (VE/VCO2) slope
时间窗: change from baseline (before rehabilitation) at 15 months (after rehabilitation)
this parameter shows the increase in ventilation in response to CO2 production, thus it measures the ventilatory efficiency
Change in peak volume oxygen - VO2 (L/min)
时间窗: change from baseline (before rehabilitation) at 15 months (after rehabilitation)
represents the maximum oxygen consumption during incremental exercise that is measured during Cardiopulmonary Exercise test (CPET), being a measure of aerobic capacity of the subject
Change in the respiratory exchange ratio (RER)
时间窗: change from baseline (before rehabilitation) at 15 months (after rehabilitation)
represents the ratio between exhaled CO2 and inhale O2 may quantify the grade of the effort
次要结局
- Change in myocardial work (MW)(change from baseline (before rehabilitation) at 15 months (after rehabilitation))
- Change in health status(change from baseline (before rehabilitation) at 15 months (after rehabilitation))
- Major adverse cardiovascular events (MACE)(through study completion, an average of 1 year)
研究者
Bernard Cosyns
Head of Department
Universitair Ziekenhuis Brussel