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临床试验/NCT04681560
NCT04681560已完成不适用

The Effect of Polychemotherapy on Endothelial Function Ans Vessel Age in Cancer Patients.

I.M. Sechenov First Moscow State Medical University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年1月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Evaluation of blood pressure

研究概览

简要总结

In this research we investigate endothelial function in cancer patients who received platinum based chemotherapy.

详细描述

The goal of the study is to evaluate endothelial function in patients with platinum-based versus non-platinum-based chemotherapy.

Endothelial function was evaluated via Angioscan( the apparatus that evaluate the stiffness of vessels by pulse wave velocity) and serum levels of endothelial nitric oxide synthase (ENOS),endothelin1.

Patients with gastrointestinal, ovarian, bladder and brest cancer would be included.

Patients with malignancies were followed-up from 2 weeks to 3 month after start of chemotherapy, Medical records and hospital databases were searched for all the patients treated with different chemotherapy treatment for any kind of cancer.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject has solid cancer
  • Subject is expected to start chemotherapy

排除标准

  • Pregnancy and lactation
  • Severe impaired kidney function
  • Severe hepatic impairment
  • Mental disease
  • Acute myocardial infarction 28 days ago or earlier
  • Acute Cerebrovascular Event 1 month ago or earlier
  • Rhythm disturbance that complicate pulse wave velocity evaluation

结局指标

主要结局

Evaluation of blood pressure

时间窗: Before start of chemotherapy (1 hour after including in the trial)

Both systolic and diastiolic blood pressure were measured in the office in the seated position, noninvasively.

Evaluation of flow-mediated vasodilation and pulse-wave velocity

时间窗: Before start of chemotherapy (1 hour after including in the trial)

Flow-mediated dilatation and pulse-wave velocity were measured via "Angioscan" apparatus in the seated position.The cuff inflation period of 5 min was initially decided to produce adequate hyperaemia to allow flow-mediated dilatation. The scanning period used in our trial was 1 minite before and 9 minutes after the cuff deflation.

Evaluation of concetration of ENOS and Big Endothelin in blood sampling

时间窗: Before start of chemotherapy (1 hour after including in the trial)

Blood was collected from the cubital vein to 10.0 ml/ 6.0 ml red top tubes (without clot activator). The sample was then separated by centrifugation. The serum was frozen to -20C.

次要结局

  • Evaluation of blood pressure(In range of 3 -12 weeks after start of chemotherapy (before next chepotherapy drug injection))
  • Evaluation of concetration of ENOS and Big Endothelin of blood sampling(In range of 3 -12 weeks after start of chemotherapy (before next chepotherapy drug injection))
  • Evaluation of flow-mediated vasodilation and pulse-wave velocity(In range of 3 -12 weeks after start of chemotherapy (before next chepotherapy drug injection))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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