Thoracic Fluid Assessment by Dynamic Contrast-enhanced Magnetic Resonance Imaging and Bioimpedance Spectroscopy: An Explorative Study in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Bolus kinetic parameters using Contrast-enhanced-MRI and BIS
研究概览
简要总结
Heart failure (HF) is a major health problem, which is characterized by reduced cardiac function leading to pulmonary congestion. Most episodes of acute HF requiring unplanned hospitalization are due to pulmonary congestion. There is an urgent clinical need for quantitative, reproducible, minimally invasive, and noninvasive methods to assess thoracic fluid status. The potential value of dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) to this end has been suggested and demonstrated in-vitro. In this study the investigators aim to compare intra-thoracic fluid volume assessed by DCE- MRI using bolus kinetic parameters of the indicator dilution theory and bioimpedance spectroscopy (BIS).
Primary objectives: This study evaluates the correlation between change in BIS and change in bolus kinetic parameters in response to a fluid challenge.
Secondary objectives: The sensitivity of the bolus kinetic parameters to fluid challenges and the normal range DCE-MRI bolus kinetic parameters is evaluated in healthy subjects.
Study design: Prospective nonrandomized pilot study.
Study population: Healthy volunteers.
Intervention: The subjects will receive an intra-venous injection of gadolinium, a MRI contrast agent. External pressure will be applied by means of a leg-compression device in order to induce a rapid increase of the preload by blood auto-transfusion.
Main study parameters: Pulmonary transit time (PTT), skewness of the indicator dilution curve which is a measure of trans-pulmonary dilution, intrathoracic blood volume (ITBV), changes in bolus kinetic parameters, and thoracic impedance in response to fluid challenges. The correlation between changes in bolus kinetic parameters and thoracic impedance in response to fluid challenges.
详细描述
HF is a major health problem that affects 6.5 million people in Europe and 200.000 in the Netherlands. HF is characterized by frequent and often costly hospitalizations. Most hospitalizations for acute heart failure are due to pulmonary congestion rather than low cardiac output syndrome. Congestion is one of the clinical targets for current therapeutic approaches. Therefore, the assessment of fluid status is crucial for diagnosis, management, stratification and follow-up of HF patients.
Existing HF diagnostic tools:
Congestion is usually assessed by clinical signs such as dyspnea, oedema, rales, and jugular venous distension. Semi-quantitative scores have been developed, which may be used to follow-up response to HF therapy. However, these scores offer limited added clinical value because of the lack of an acceptable reproducibility, specificity, and sensitivity.
Indicator dilution theory and bolus kinetic analysis:
Assessment of congestion is possible by kinetic analysis of a bolus of a suitable indicator. Circulation tests based on this principle are well-known techniques to diagnose cardiac failure. Lower cardiac output (CO) and large lung blood volumes result in prolongation of circulation times.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >18 years
- •Informed consent.
- •Body mass index between 18 and 25
排除标准
- •End-stage renal or hepatic disease
- •Pregnancy
- •Mild or moderate renal insufficiency, (GFR<60 mL/min);
- •Risk for developing nephrogenic systemic fibrosis;
- •General contra-indications to magnetic resonance imaging
- •Pro-inflammatory state, vascular endothelial dysfunction
研究组 & 干预措施
Thoracic fluid status assessment
Cardiac MRI by a 1.5 Tesla scanner:
- Left ventricular ejection fraction (LVEF), tracing short axis endocardial borders.
- CO, phase contrast angiography.
- Fluid challenge by auto-transfusion by distal leg compression using inflatable cuffs (Lympamat Digital Gradient system).
- DCE-MRI, bolus injection of Gd-CA intravenously by an injector. Each subject will receive repeated injections (10% of maximum dose).
- BIS, impedance will be measured continuously using ImpediMed-SFB7 and surface electrodes on the thorax. .
干预措施: MRI (Device)
Thoracic fluid status assessment
Cardiac MRI by a 1.5 Tesla scanner:
- Left ventricular ejection fraction (LVEF), tracing short axis endocardial borders.
- CO, phase contrast angiography.
- Fluid challenge by auto-transfusion by distal leg compression using inflatable cuffs (Lympamat Digital Gradient system).
- DCE-MRI, bolus injection of Gd-CA intravenously by an injector. Each subject will receive repeated injections (10% of maximum dose).
- BIS, impedance will be measured continuously using ImpediMed-SFB7 and surface electrodes on the thorax. .
干预措施: Gd-CA (Drug)
Thoracic fluid status assessment
Cardiac MRI by a 1.5 Tesla scanner:
- Left ventricular ejection fraction (LVEF), tracing short axis endocardial borders.
- CO, phase contrast angiography.
- Fluid challenge by auto-transfusion by distal leg compression using inflatable cuffs (Lympamat Digital Gradient system).
- DCE-MRI, bolus injection of Gd-CA intravenously by an injector. Each subject will receive repeated injections (10% of maximum dose).
- BIS, impedance will be measured continuously using ImpediMed-SFB7 and surface electrodes on the thorax. .
干预措施: BIS ImpediMed™ SFB7 (Device)
Thoracic fluid status assessment
Cardiac MRI by a 1.5 Tesla scanner:
- Left ventricular ejection fraction (LVEF), tracing short axis endocardial borders.
- CO, phase contrast angiography.
- Fluid challenge by auto-transfusion by distal leg compression using inflatable cuffs (Lympamat Digital Gradient system).
- DCE-MRI, bolus injection of Gd-CA intravenously by an injector. Each subject will receive repeated injections (10% of maximum dose).
- BIS, impedance will be measured continuously using ImpediMed-SFB7 and surface electrodes on the thorax. .
干预措施: Autotransfusion Lympamat Digital Gradient system (Device)
结局指标
主要结局
Bolus kinetic parameters using Contrast-enhanced-MRI and BIS
时间窗: 30 minutes
Correlation between changes in PTT and skewness of transpulmonary dilution system by DCE-MRI and changes in extravascular resistance measured by bio-impedance spectroscopy
次要结局
- Fluid challenge response(15 minutes)
- Bolus kinetic parameters (Optimal DCE-MRI imaging sequence and range of normal values for ITBV, PTT and skewness of transpulmonary circulation measured by DCE-MRI in healthy subjects)(5 minutes)
- Bolus kinetic parameters and hemodynamic parameters.(5 minutes)
研究者
Ingeborg Herold
MD
Catharina Ziekenhuis Eindhoven