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临床试验/NCT05508087
NCT05508087已完成不适用

Cardiovascular Diagnostic in Assessment of Risk High Dose Chemotherapy and Hematopoietic Cell Transplantation in Patients With Haemoblasts.

I.M. Sechenov First Moscow State Medical University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年7月17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
150
试验地点
1
主要终点
Cardiac death

研究概览

简要总结

In this research we 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 high dose chemotherapy and hematopoietic cell transplantation in patients with haemoblasts.

详细描述

Cancer and cardiovascular (CV) disease are the most prevalent diseases in the developed world. Evidence increasingly shows that these conditions are interlinked through common risk factors, coincident in an ageing population, and are connected biologically through some deleterious effects of anticancer treatment on CV health. Anticancer therapies can cause a wide spectrum of short- and long-term cardiotoxic effects such as heart failure, arrhythmias, systolic and diastolic dysfunction, valvular disease, pericarditis, myocarditis, ischemic heart disease, cardiomyopathy, stroke, hypertension.

A number of studies have shown that autologous and allogeneic hematopoietic cell transplantation (HCT) contribute to an increased incidence of cardiovascular disease (CVD) and worsening of cardiovascular risk factors (CVRFs) that could contribute to further CVD over time. These observations combined with a notable increase in the number of survivors after HCT in recent years highlight the need for studies aimed at modifying risk or preventing these outcomes by changing specific approaches and/or post-HCT interventions.

The aim of this study is to evaluate the prognostic value of cardiological 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 high dose chemotherapy and hematopoietic cell transplantation in patients with haemoblasts.

This is an observational, prospective single- centre, non-randomized study. In this research included patients with haemoblasts. Before and after hematological treatment, all patients undergo a cardiological examination, including examination, history taking, measurement of blood pressure, as well as instrumental examination, including ECG, echocardiography with the determination of global longitudinal deformation, cardiopulmonary pulmonary test, assessment of endothelial function by Angioscan. In addition, all subjects take blood for troponin T and NT-proBNP.

Patients were followed-up from 3 to 12 month after hematopoietic cell transplantation.

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

盲法说明

to evaluate the possibility of cardiovascular studies in predicting the risk of complications after autologous hematopoietic stem cell transplantation in patients with hematological malignancies

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 being over 18 yers of age
  • Subject expected for high dose chemotherapy and hematopoietic cell transplantation

排除标准

  • Subject's refusal

结局指标

主要结局

Cardiac death

时间窗: Up to 5 years or in the moment of hematopoietic cell transplantation

Cardiac death after hematopoietic cell transplantation

Death

时间窗: Up to 5 years or in the moment of hematopoietic cell transplantation

Death after hematopoietic cell transplantation

次要结局

  • All cardiovascular complications(Up to 5 years or in the moment of hematopoietic cell transplantation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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