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临床试验/NCT05041452
NCT05041452Unknown不适用

Multiparametric Cardio-hepatic MRI in Patients With Noncirrhotic Portal Hypertension

University Hospital, Bonn2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年4月29日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
Myocardial T1 relaxation time

研究概览

简要总结

The aim of this study is to use multiparametric MRI to investigate any differences in myocardial structure and function in patients with noncirrhotic portal hypertension compared with a control group with liver cirrhosis.

详细描述

The term "cirrhotic cardiomyopathy" (CCM) was defined in 2005 according to expert consensus at the "World Congress of Gastroenterology" in Montreal as a clinical phenotype in patients with liver cirrhosis consisting of systolic and diastolic dysfunction and a complementary criterion, such as electrophysiological changes, without the presence of a known underlying cardiac disease. For a long time, CCM was considered to result from toxic effects of alcohol consumption. The current view is that CCM is a separate entity independent of the various etiologies of liver cirrhosis. Thus, generally impaired liver function and portal hypertension with splanchnic vasodilation leads to altered hemodynamic conditions with central hypovolemia, increased activation of volume and baroreceptors, especially of the sympathetic nervous system, resulting in a "hyperdynamic syndrome" with increased cardiac stress. However, the contribution of portal hypertension to CCM is unclear.

With new MRI techniques such as cardiac T1 and T2 mapping and extracellular volume fraction (ECV), quantitative parameters are available to detect pathologies of the myocardium before they become detectable with conventional techniques in cardiac MRI or echocardiography.

The aim of this study is to use multiparametric MRI to investigate any differences in myocardial structure and function in patients with noncirrhotic portal hypertension compared with a control group with liver cirrhosis and to investigate a quantifiable correlation between cardiac, hepatic, and splenic parameters.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Myocardial T1 relaxation time

时间窗: Measurement will be performed within 2 weeks after MRI scan.

T1 relaxation times will be obtained to asses acute myocardial injury and fibrosis. T1 maps will be analyzed using a segmental approach by region of interest analysis. T1 relaxation times are given in \[ms\].

次要结局

  • Myocardial T2 relaxation time(Measurement will be performed within 2 weeks after MRI scan.)
  • Myocardial strain(Measurement will be performed within 2 weeks after MRI scan.)
  • Myocardial ECV(Measurement will be performed within 2 weeks after MRI scan.)

研究者

发起方
University Hospital, Bonn
申办方类型
Other
责任方
Principal Investigator
主要研究者

Julian Alexander Luetkens

Principal Investigator, Senior Physician

University Hospital, Bonn

研究点 (2)

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