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临床试验/NCT00936416
NCT00936416已完成不适用

Assessment of Renal Physiology (Glomerular Filtration Rate and Blood Flow) by MRI With Validation by Inulin and Para-Aminohippuric Acid Clearance in Normal Volunteers

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
GFR estimation comparison between results obtained by MRI and Inulin clearance method. Blood flow estimation comparison between results obtained by MRI and PAH clearance method.

研究概览

简要总结

Estimation of Glomerular Filtration Rate (GFR) is the primary test used to assess patients with renal disease. Although serum creatinine based GFR and nuclear medicine based estimations are routinely used in clinical practice, GFR estimation by Inulin is the recommended gold standard. Inulin based estimation of GFR is cumbersome and time consuming.

A decrease in blood flow to the kidney (Renal Blood Flow (RBF)) is known to cause a decrease in GFR. RBF is typically determined using radioactive tracers, contrast MRI or a cumbersome para-aminohippuric acid (PAH) clearance method.

MRI based assessment of GFR and RBF have been suggested to provide reasonable accuracy. Most of these studies did not compare the GFR and RBF estimation directly to Inulin and PAH clearance which are ther gold standards . In this study we propose to estimate MRI based GFR estimation directly to Inulin and noncontrast MRI based derived RBF to PAH to assess if MRI is an accurate test of kidney function.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy male or female volunteers with no known renal disease
  • Ages between 18-65 years
  • Normal routine urinalysis
  • Estimated GFR (eGFR) >=90mls/min
  • Arterial pressure < 130/85
  • No medications (birth control pills and vitamins are acceptable)

排除标准

  • Pregnancy
  • Age <18y or >65y
  • Proteinuria or hematuria as determined by routine urinalysis
  • Estimate GFR (eGFR) < 90 ml/min
  • Known history or requirement of treatment for hypertension
  • Known allergy to inulin or PAH
  • MRI contrast allergy, general contraindications to MRI such as pacemaker, etc.

结局指标

主要结局

GFR estimation comparison between results obtained by MRI and Inulin clearance method. Blood flow estimation comparison between results obtained by MRI and PAH clearance method.

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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