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临床试验/NCT02054494
NCT02054494Unknown不适用

Myocardial T1-mapping and T1-derived Extracellular Volume Fraction (ECV) in HIV-infection Patients With Chronic High and Low CD4+ Counts and in a Healthy Control Group

University Hospital, Bonn1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Native T1 Relaxation Times

研究概览

简要总结

HIV-infection is associated with an increased risk for cardiovascular disease. Especially patients with low CD4+ counts have a higher incidence of structural heart disease. Myocardial T1 relaxation time, as well as T1-derived extracellular volume fraction are relatively new methods for non-invasive myocardial tissue characterization, including diffuse myocardial fibrosis.

In our study HIV-patients with high and low CD4+ counts are examined on a 3T MRI scanner (Ingenia 3T, Philips Medical, Best, Netherlands). Scanning protocol includes common SSFP sequences, STIR imaging and LGE [Late gadolinium enhancement]. All HIV patients are treated in the HIV outpatient clinic of the hospital's Internal Medicine department and have an unremarkable history of cardiac disease. Patients are recruited from all over Germany. In order to obtain reference values, a subgroup of healthy, age-matched controls is included in this study.

Aim of this study is to show differences in T1- and ECV-values in the investigated subgroups. In addition, we also want to create cut-off values for healthy and affected myocardium in asymptomatic HIV-infected patients. This study could show whether myocardial T1 mapping is a potential screening parameter for beginning heart disease as part of an HIV-infection, and whether an application in routine diagnostic is reasonable.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • chronic HIV infection
  • no known cardiac disease
  • no cardiovascular risk factors

排除标准

  • contraindications to MRI (e.g. metal implants)
  • chronic kidney disease

结局指标

主要结局

Native T1 Relaxation Times

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

T1 relaxation times will be directly obtained form the T1 maps through ROI analysis. T1 maps will be analyzed using a segmental approach. T1 relaxation times are given in \[ms\].

次要结局

  • Extracellular volume fraction (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

Claas P. Naehle

PD Dr. med.

University Hospital, Bonn

研究点 (1)

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