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临床试验/NCT02399384
NCT02399384已完成不适用

Myocardial Adipose Inflammation and Pericardial Adipose Volume as Markers for Coronary Artery Disease In HIV Positive Patients

University of Cincinnati1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2015年1月14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
12
试验地点
1
主要终点
Pericardial adipose tissue volume

研究概览

简要总结

The investigators propose to correlate 1) cardiac MRI pericardial adipose volume, 2) the presence of pericardial monocytes and 3) circulating immune biomarkers in persons with and without CHD and HIV infection compared to seronegative controls with known CHD. The investigators aim to test the hypothesis that higher amounts of pericardial fat deposition and increased presence of monocytes within this adipose tissue are associated with underlying coronary artery disease in persons with HIV infection as measured by cardiac MRI.

详细描述

Methods and Procedures:

Screening Assessments Patients who potentially meet inclusion criteria will be identified through the Infectious Disease Center and/or the cardiac catheterization laboratory who have had a coronary angiogram or cardiac CT angiogram, with or without evidence of CAD. Their records will be reviewed for inclusion and exclusion criteria and informed consent will be obtained prior to any research related procedures by a member of the research team for this project.

A screening visit will be done to obtain informed consent. BUN and Creatinine will be done at screening to ensure the safety of the MRIprocedure.

In HIV-infected subjects who have not had HIV-1 RNA or CD4+ lymphocyte tests obtained in the last 60 days, these will be done at screening.

Screening visits will last approximately 30-60 minutes.

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

入选标准

  • > 18 years of age
  • History of HIV disease or no history of HIV
  • Prior history of left heart catheterization or CTA indicating the presence or absence of CAD.

排除标准

  • Unable to have a contrast enhanced cardiac MRI, (i.e. ferromagnetic foreign body, inability to follow verbal instructions, prior history of allergic reactions to gadolinium, history of nephrogenic systemic fibrosis, severe renal dysfunction GFR<30 ml/min/1.73 m2, or severe claustrophobia/anxiety);
  • Chronic kidney disease patient undergoing hemodialysis or peritoneal dialysis
  • Allergy to Iron Compounds;
  • Pregnant females.

结局指标

主要结局

Pericardial adipose tissue volume

时间窗: On baseline imaging

次要结局

  • Adipose spin spin relaxivity as measured by T2 star time(At baseline and 48-72 hours later)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Harris

Cardiac Imaging Director

University of Cincinnati

研究点 (1)

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