Assessment of Renal Microcirculation With Rubidium Positron Emission Tomography: A Proof-of-Concept Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Renal blood flow in units of mL/min/100g
研究概览
简要总结
The aim of this study is to demonstrate that positron emission tomography imaging with Rubidium-82 (radioactive tracer) can non-invasively detect and quantify changes in renal blood flow (renal perfusion) and renal vascular resistance in both healthy subjects and patients with renal insufficiency. Ultimately, the results of this study will contribute to a better understanding of the role of positron emission imaging in the evaluation of patients with renal diseases.
详细描述
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Hypothesis
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We hypothesize that RBF assessed with rubidium PET is on average lower in patients with CKD. To test our hypothesis, RBF of patients with CKD and coronary artery disease (CAD) risk factors, a population characterized by renal microvascular rarefaction, will be compared to RBF of healthy controls.
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We hypothesize that RVR assessed with rubidium PET correlates with echographic measurements of renal resistance index (RI), the current non-invasive method of choice.
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We hypothesize that RBF quantification with rubidium PET is technically reproducible, meaning that the variation on the measurements of RBF purely attributable to technical factors (camera, positioning, tracer injection, etc.) is relatively small. To test this hypothesis, two PET scans will be acquired within a short time period.
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Objectives and Endpoints 3.1. Primary Objective
- To compare RBF of patients with CKD and CAD risk factors to healthy controls 3.2. Secondary Objectives
- To compare RVR of patients with CKD and CAD risk factors to healthy controls
- To evaluate the correlation between RVR measured with PET to renal RI as measured with echography
- To evaluate the repeatability and reproducibility of in vivo measurements of RBF and RVR
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Control Group
- •Age ≥ 18 years and < 80 years
- •Signed informed consent
- •No medical history of renal disease
- •Age ≥ 18 years and < 80 years
- •Signed informed consent
- •GFR between 30 and 45 mL/min/1.73m2 measured within the last 3 months
- •At least two cardiovascular disease risk factors such as hypertension, smoking, diabetes, obesity, and dyslipidemia
排除标准
- •Control Group
- •Hypertension
- •Dyslipidemia
- •Active smoking within the last 12 month
- •Left ventricular ejection fraction <45%
- •BMI >45 kg/m2
- •Severe aortic stenosis
- •Left ventricular ejection fraction <45%
- •BMI >45 kg/m2
- •Severe aortic stenosis
- •Changes in medical therapy within the last 4 weeks
- •Documented renal artery stenosis
- •Known structural cause of CKD including polycystic kidney disease, obstruction, or other post-renal causes
- •Pregnancy or breastfeeding
- •Renal failure requiring dialysis within the last 90 days
结局指标
主要结局
Renal blood flow in units of mL/min/100g
时间窗: 1 day
Average difference of RBF between healthy controls and CKD participants
次要结局
- Renal vascular resistance in units of mmHg/mL/min/100g(1 day)
- Correlation between renal vascular resistance measured with PET and measured with echography(Up to 4 weeks)
- Coefficient of repeatability of renal blood flow(1 day)
研究者
Matthieu Pelletier-Galarneau, MD MSc
MD MSc
Montreal Heart Institute