Cardiovascular Disorders and Risk Factors in Childhood Cranial and Craniospinal Tumors Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- change in exercise tolerance
研究概览
简要总结
The purpose of research is to study to adverse cardiovascular disorder and risks factors in childhood cranial and craniospinal tumors survivors. In this research the investigators investigate cardiological instrumental diagnostic, such as electrocardiography, echocardiography with the determination of global longitudinal strain, cardiopulmonary exercise test, and diagnostic of endothelial function by Angioscan for the prediction of cardiovascular complications after cranial and craniospinal radiotherapy and chemotherapy.
详细描述
Cardiovascular disease, after recurrence of the original cancer and development of second primary cancers, has been reported to be the leading cause of premature mortality among long-term childhood cancer survivors. Childhood cancer survivors after chemotherapy and radiotherapy for cranial and craniospinal tumors are at increased risk of transient ischemic attack, ischemic stroke. The mechanisms of vascular damage are not well understood. Preventive measures are not developed.
The purpose of my research is to study to adverse cardiovascular disorder and risks factors in childhood cranial and craniospinal tumors survivors.
Cardiovascular risk factors monitoring and modification, development of nursing and follow-up guides of adult patients may improve outcomes in these patients after treatment for cranial and craniospinal tumors in childhood. Attempts to develop more individualized risk prediction for cardiovascular disease may help refine surveillance and counseling in the future.
This was an open prospective observational study. 68 people were enrolled in the study: 48 childhood cancer survivals after complex management of cranial and craniospinal tumors formed the main group, and 20 healthy people formed the control group.
Criteria of inclusion to the main group were: age 16-40 years, radiation and chemotherapy for cranial and craniospinal tumors in childhood or adolescence, completion of the therapy at least one year before enrollment, signed informed consent. There were three separate types of informed consent - for adults, for minors and for their parents. Minors were signing informed consent in the presence of their parents.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •radiation and chemotherapy for cranial and craniospinal tumors in childhood or adolescence
- •completion of the therapy at least one year before enrollment
- •signed informed consent
- •there were three separate types of informed consent - for adults, for minors and for their parents
- •minors were signing informed consent in the presence of their parents.
排除标准
- •standard contraindications to exercise testing
- •anemia, pregnancy
- •psychiatric disease
- •alcohol or drug abuse
- •active malignancy
- •acute infection
结局指标
主要结局
change in exercise tolerance
时间窗: At baseline and through study completion of 1 year
change anaerobic threshold\<14,0 ml/kg/min
Dyslipidemia
时间窗: At baseline and through study completion of 1 year
change сoncentration of total cholesterol \>5 mmol/l, change сoncentration of LDL \> 3 mmol/l, сoncentration of HDL \<1,2 mmol/l, change сoncentration of TG \>1,7 mmol/
endotelian dysfunction
时间窗: At baseline and through study completion of 1 year
change in endothelial function by Angioscan
次要结局
未报告次要终点